Utility of endoscopic ultrasound-guided hepaticoduodenostomy for intrahepatic bile duct drainage: a multicenter retrospective study in western Japan

Utility of endoscopic ultrasound-guided hepaticoduodenostomy for intrahepatic bile duct drainage: a multicenter retrospective study in western Japan | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Utility of endoscopic ultrasound-guided hepaticoduodenostomy for intrahepatic bile duct drainage: a multicenter retrospective study in western Japan Ken Kamata, Atsushi Okuda, Takeshi Ogura, Yuzo Shimokawa, Akihisa Ohno, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7698529/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : There are several biliary drainage procedures for biliary strictures, including endoscopic ultrasound-guided hepaticoduodenostomy (EUS-HDS). However, only a few studies have investigated the technical and clinical success of this procedure with a small number of cases at single high-volume centers. Objective: This multicenter, non-controlled, retrospective study evaluated the safety and efficacy of EUS-HDS for intrahepatic bile duct drainage. Methods : Consecutive patients who underwent EUS-HDS at one of 12 Japanese referral centers between January 2010 and December 2024 were enrolled. The primary endpoint was clinical success. The secondary endpoints were technical success, stent patency, and complications. Results : A total of 35 eligible patients were analyzed. Perihilar biliary stenosis was observed in 32 of 35 patients (91.4%) and right posterior sectoral bile ducts were targeted by EUS-HDS in 28 of 35 patients (80.0%). Technical success was achieved in 31 of 35 patients (88.6%) and clinical success was achieved in 24 of 31 patients (77.4%) according to per-protocol analysis. Median stent patency was 285 (6–999) days. An early procedural adverse event (mild peritonitis) occurred in one case. Patency did not significantly differ between plastic and metal stents (P=0.117). In multivariable analysis, less severe than mild cholangitis (P=0.073) and biliary stent deployment before EUS-HDS (P=0.065) tended to predict clinical effectiveness. Conclusions : EUS-HDS may be a feasible and effective treatment, especially for cases with some degree of controlled cholangitis achieved by adequate biliary drainage other than bile ducts targeted by EUS-HDS. biliary cholangiocarcinoma drainage endosonography jaundice Figures Figure 1 Introduction Biliary drainage procedures for biliary strictures includes percutaneous transhepatic biliary drainage (PTBD), endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD has been widely performed in recent years, especially at advanced facilities 1 – 11 . The main procedural steps are puncture of the biliary tract, dilation of the puncture site, and placement of a stent, which allows one-stage internal biliary drainage. Stenting sites vary widely and include the left intrahepatic bile duct-stomach, right intrahepatic bile duct-duodenum, common bile duct-duodenum, and gallbladder-duodenum. Endoscopic ultrasonography-guided hepaticoduodenostomy (EUS-HDS) is relatively rarely used, but can be performed in cases of ERCP failure or as an alternative to PTBD. It has the advantage of being applicable to bile ducts of the right posterior segment; however, there are only a few reports regarding technical and clinical successes of this procedure using a small number of cases at single high-volume centers 12 , 13 . The reasons for this are that there are few cases of trans-papillary approach failure or in which only the right posterior sectoral bile duct is responsible for cholangitis, and this procedure is difficult to perform in cases with duodenal stenosis. The aims of the present study were to evaluate the technical feasibility and clinical efficacy of EUS-HDS for intrahepatic bile duct drainage in a multicenter retrospective study, to explore in which cases this technique is performed in the real world, and to determine in which cases it is appropriate to perform this technique. Methods Patients This multicenter, non-controlled, retrospective study was approved by the Ethics Committee of the Kindai University Faculty of Medicine (number: R06-190). Consecutive patients who underwent EUS-HDS at one of 12 western Japanese referral centers between January 2010 and December 2024 were enrolled. Informed consent was obtained via opt-out on the website. All methods were performed in accordance with the relevant guidelines and regulations. The cut-off date for data analysis was April 4, 2025. EUS-HDS All EUS-HDS procedure were performed by trained endoscopists. A conventional linear array echoendoscope (GF-UCT 260; Olympus) was used for EUS-HDS. The intrahepatic bile duct was depicted from the duodenal bulb on EUS and was punctured using a 19- or 22-gauge needle (EZ Shot3; Olympus or SonoTip; Medi-Globe) after confirming there were no intervening vessels above the puncture line using Doppler mode. After the tip of the puncture needle was confirmed to be in the intrahepatic bile duct by performing EUS and aspirating bile juice with a syringe, contrast medium was injected and 0.025- or 0.018-inch guidewires (Fielder; Asahi Intecc, VisiGlide2; Olympus, EndoSelector, Pathcourse, NovaGold, or VENTY; Boston Scientific, or J-WIRE; J-MIT) were inserted into the bile duct. The puncture site was dilated using contrast (Uneven Double Lumen Cannula; Piolax), dilation (ES dilator; Zeon, Soehendra; Cook, or Tornus; Asahi Intecc), a 3–6-mm balloon catheter (REN; Kaneka), or electrocautery (Cysto-Gastro-Sets; ENDO-FLEX). In some cases, these methods were used in combination or dilation was not required. Thereafter, a 5–7-Fr plastic (Harmo Ray; Hanaco, REGULUS; Japan Lifeline, or Type-IT; Gadelius) or 6–10-mm metal (BileRush; Piolax, Niti-S or Spring Stopper; Taewoong, or Hanaro or WallFlex; Boston Scientific) stent was placed between the intrahepatic bile duct and duodenum, and it was confirmed that the stent was released into the bile duct on both EUS and fluoroscopy images. In some cases, endoscopic nasobiliary drainage was performed. Definitions Acute cholangitis and its severity were diagnosed according to the Tokyo guidelines 14 . Only confirmed cases were considered acute cholangitis. The primary endpoint was clinical success. The secondary endpoints were technical success, stent patency, and complications. Clinical success was defined as an improvement of the serum bilirubin level to less than 50% of that before treatment within 1 week after EUS-HDS or complete cure of clinical symptoms of cholangitis. To calculate clinical success rates, all cases and cases with technical success were used as denominators in the intention-to-treat and per-protocol analyses, respectively. Technical success was defined as successful deployment of the stent in the required position during EUS-HDS. The duration of stent patency was defined as the length of time between stent deployment and stent occlusion, removal, migration, or change other than routine stent replacement. Procedure-related adverse events and their severity were defined according to the recommendation of the American Society of Gastrointestinal Endoscopy 15 . Early procedural adverse events were defined as any adverse events due to EUS-HDS that developed within 2 weeks. Statistical analysis Results are presented as the median with range or numbers with percentage and/or 95% confidence interval (CI). Stent patency was analyzed in all patients with technical success by the Kaplan-Meier method with the log-rank test. For this analysis, calculations were performed by censoring death and the last follow-up date or treating them as events. Univariable and multivariable logistic regression analyses were performed to identify factors associated with the clinical effectiveness of EUS-HDS. The odds ratio (OR) and 95% CI were calculated. Variables with a P value <0.2 in univariable analysis were included in multivariable analysis. Effects were considered statistically significant at P < 0.05, and a P value between 0.05 and 0.1 was considered to indicate a tendency. Statistical analyses were performed using GraphPad Prism (GraphPad Software). Results Patient characteristics A total of 35 patients who underwent EUS-HDS during the study period were enrolled. Patient characteristics at baseline are shown in Table 1 . Of the 35 patients, 33 had primary malignancy and about half had cholangiocarcinoma (intrahepatic; n = 3, peripheral; n = 12, distal; n = 3). Cholangitis was less severe than mild in most cases, and one of the 10 cases with moderate cholangitis was complicated by a liver abscess. Most patients had perihilar biliary stenosis with segregated left and right intrahepatic bile ducts; however, four patients underwent surgical resection of the left hepatic lobe. Nine patients received at least five biliary interventions, and only two patients had never received them before EUS-HDS regardless of success or non-success. The main causes of failed ERCP-mediated drainage of bile ducts targeted by EUS-HDS were a tight stricture (n = 22), a previous stent mesh (n = 5), and surgically altered anatomy (n = 6). These patients included one patient in whom ERCP was not performed because of anticipated difficulty in penetrating the bile duct stricture and three patients in whom ERCP was not performed because of anticipated difficulty in reaching the bile duct orifice due to surgically altered anatomy. Twenty-four patients had undergone one or more stent deployments in any bile ducts that were not targeted by EUS-HDS, and the remaining 11 patients had not undergone stent deployment prior to EUS-HDS. Table 1 Patient characteristics at baseline (n = 35) Sex, n (%) Male Female 17 (48.6) 18 (51.4) Median age, years (range) 76 (29–89) Performance status, n (%) 0 1 2 3 15 (42.9) 14 (40.0) 5 (14.3) 1 (2.9) American Society of Anesthesiologists physical status, n (%) 0 1 2 3 4 1 (2.9) 4 (11.4) 20 (57.1) 4 (11.4) 6 (17.1) Median age-adjusted Charlson comorbidity index (range) 9 (0–13) Primary diseases, n (%) Hepatocellular carcinoma Cholangiocarcinoma Gallbladder cancer Pancreatic cancer Gastric cancer Colon cancer Peritoneal cancer Hepaticojejunostomy anastomotic stricture Traffic injury 1 (2.9) 18 (51.4) 4 (11.4) 2 (5.7) 1 (2.9) 6 (17.1) 1 (2.9) 1 (2.9) 1 (2.9) Degree of cholangitis, n (%) Absence Mild Moderate Severe 8 (22.9) 17 (48.6) 10 (28.6) 0 (0) Location of biliary stenosis*, n (%) Distal Perihilar Right intrahepatic 1 (2.9) 32 (91.4) 5 (14.3) Segregated left and right intrahepatic bile ducts, n (%) Presence Absence 26 (74.3) 9 (25.7) Median number of biliary interventions before EUS-HDS † , n (range) 2 (0–11) History of PTBD, n (%) Presence Absence 5 (14.3) 30 (85.7) History of ERCP, n (%) Presence Absence 30 (85.7) 5 (14.3) History of EUS-HGS, n (%) Presence Absence 12 (34.3) 23 (65.7) Cause of failed ERCP drainage prior to EUS-HDS, n (%) Bile duct cannulation failure Tight stricture Previous stent mesh Surgically altered anatomy 2 (5.7) 22 (62.9) 5 (14.3) 6 (17.1) Number of stents deployed before EUS-HDS, n (%) 0 1 Multiple 11 (31.4) 8 (22.9) 16 (45.7) Type of stent deployed before EUS-HDS ‡ , n (%) Plastic stent Metal stent Both 6 (25.0) 14 (58.3) 4 (16.7) Median interval from last drainage to EUS-HDS § , days (range) 17 (1–197) *There were duplicate cases. † Calculated by including non-successful cases. ‡ The percentage was calculated using 24 cases with stent deployment as the denominator. § Calculated using 24 cases with stent deployment before EUS-HDS. ERCP, endoscopic retrograde cholangiopancreatography; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; PTBD, percutaneous transhepatic biliary drainage. Procedure details and outcomes of EUS-HDS Procedure details of EUS-HDS are shown in Table 2 . The median procedure duration was 35 minutes, and the shortest procedure duration among successful cases was 10 min. The technical success rate was 88.6% (95% CI; 73.5–96.1%). In one case, the bile duct could not be punctured due to an intervening vessel. In two cases, the guidewires only peaked at the peripheral bile ducts and the procedures were abandoned at the preliminary stage of dilatation of the puncture site. In one case, the puncture site was not dilated properly and stent placement was not possible. The main puncture sites were B6 and B7. Plastic and metal stents were used in 16 and 15 patients, respectively. Stent size and length were appropriately chosen for each case and varied. Table 2 Procedure details of EUS-HDS (n = 35) Median diameter of target bile duct on EUS, mm (range) 5.0 (1.5–9.2) Median procedure duration, min (range) 35 (8–245) Technical success, n (% [95% CI]) 31 (88.6 [73.5–96.1]) Failure phase*, n (%) Puncture Dilation Stent deployment 1 (25.0) 2 (50.0) 1 (25.0) Puncture site † , n (%) B1 B5 B6 B7 B8 Detail unknown 1 (2.9) 2 (5.9) 22 (64.7) 6 (17.6) 1 (2.9) 2 (5.9) Size of puncture needle † , n (%) 19-gauge 22-gauge 30 (88.2) 4 (11.8) Size of guidewire † , n (%) 0.025-inch 0.018-inch Detail unknown 30 (88.2) 3 (8.8) 1 (2.9) Method of fistula dilatation ‡ , n (%) Contrast catheter Dilation catheter Balloon catheter Dilation plus balloon catheter Electrocautery Not required 3 (9.4) 9 (28.1) 12 (37.5) 5 (15.6) 1 (3.1) 2 (6.3) Type of stent § , n (%) Plastic stent Metal stent 16 (51.6) 15 (48.4) Size of stent § , n (%) Plastic stent 5 Fr 6 Fr 7 Fr Detail unknown Metal stent 6 mm 8 mm 10 mm 1 (3.2) 2 (6.5) 12 (38.7) 1 (3.2) 2 (6.5) 9 (29.0) 4 (12.9) Length of stent § , n (%) Plastic stent 7 cm 10 cm 12 cm 14 cm ENBD Detail unknown Metal stent 6 cm 8 cm 10 cm 12 cm 2 (6.5) 1 (3.2) 1 (3.2) 8 (25.8) 3 (9.7) 1 (3.2) 1 (3.2) 8 (25.8) 3 (9.7) 3 (9.7) *The percentage was calculated using four cases with failure as the denominator. † The percentage was calculated using 34 cases with puncture as the denominator. ‡ The percentage was calculated using 32 cases with dilation as the denominator. § The percentage was calculated using 31 cases with stent deployment as the denominator. CI, confidence interval; ENBD, endoscopic nasobiliary drainage; EUS, endoscopic ultrasonography; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy. Outcomes after EUS-HDS are shown in Table 3 . The clinical success rate in the intention-to-treat and per-protocol analyses was 68.6% (95% CI; 51.9–81.6%) and 77.4% (95% CI; 59.9–88.9%), respectively. There was one case of peritonitis, which was an early procedural adverse event. Of the 21 patients who required re-intervention after EUS-HDS, the EUS-HDS route was used in 12 patients. These 12 patients included two who underwent routine stent replacement. Median stent patency with last follow-up and death censored and treated as events was 285 (6–999) days and 77 (6–999) days, respectively. Patency of plastic and metal stents did not significantly differ in analyses with last follow-up and death censored (238.0 vs. 285.0 days, P = 0.117) and treated as events (64.5 vs. 77.0 days, P = 0.455). Excluding patients with technical failure, factors predicting the clinical effectiveness of EUS-HDS were compared between the 24 patients with clinical success and the seven patients with clinical failure. Univariable analysis showed that cholangitis more severe than moderate and biliary stent deployment before EUS-HDS were candidate factors related to clinical effectiveness (Table 4 ). Multivariable analysis revealed that cholangitis more severe than moderate and biliary stent deployment before EUS-HDS tended to be negatively (OR; 0.11, 95% CI; 0.00–1.00, P = 0.073) and positively (OR; 9.16, 95% CI; 1.13–196.20, P = 0.065) associated with clinical success of EUS-HDS, respectively (Table 5 ). Table 3 Outcomes after EUS-HDS (n = 35) Clinical success, n/N (% [95%CI]) Intention-to-treat analysis Per-protocol analysis 24/35 (68.6 [51.9–81.6]) 24/31 (77.4 [59.9–88.9]) Early procedural adverse events, n (%[95%CI]) Mild Moderate Severe 1 (2.9 [-0.8–15.8]) 0 0 Re-intervention rate*, n/N (%) 21/35 (60.0) Frequency of re-interventions, n (%) 0 1 2 More than 3 16 (45.7) 6 (17.1) 3 (8.6) 10 (28.6) Re-intervention rate using the EUS-HDS route † , n/N (%) 12/31 (38.7) Median stent patency*, days (range) Last follow-up or death censored Last follow-up or death treated as an event 285 (6–999) 77 (6–999) Median follow-up duration, days (range) 131 (6–999) *Includes all biliary drainage treatments performed after EUS-HDS. † Calculated using 31 cases with technical success. CI, confidence interval; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy. Table 4 Univariable analysis of factors associated with the clinical effectiveness of EUS-HDS in 31 patients with technically successful procedures. Independent variable OR 95% CI P value Male 0.63 0.11–3.49 0.600 Older than 76 years 1.33 0.24–8.02 0.740 PS 2 or higher 0.36 0.05–3.25 0.322 ASA-PS 3 or higher 1.03 0.17–8.38 0.976 Charlson comorbidity index 9 or higher 0.63 0.11–3.49 0.600 Hepatobiliary pancreatic cancer 1.82 0.30–10.55 0.499 Cholangitis more severe than moderate 0.27 0.04–1.77 0.160 Biliary stenosis of the hepatic hilum NA* NA* NA* Segregated left and right intrahepatic bile ducts 0.40 0.02–3.03 0.439 At least two previous biliary interventions before EUS-HDS 2.67 0.48–16.51 0.264 History of PTBD 0.36 0.05–3.25 0.322 History of ERCP 2.80 0.31–21.96 0.322 History of EUS-HGS 3.00 0.41–61.75 0.345 Surgically altered anatomy the cause of ERCP failure 0.50 0.07–4.33 0.488 Biliary stent deployment before EUS-HDS 4.00 0.70–25.86 0.123 Metal stent deployment before EUS-HDS 1.33 0.24–8.02 0.740 Diameter of target bile duct larger than 5mm 1.05 0.17–5.83 0.955 Procedure time longer than 35 min 0.40 0.05–2.27 0.325 Puncture site B6 2.25 0.36–13.42 0.366 Use of a 19-gauge puncture needle 1.17 0.05–11.23 0.901 Use of a 0.025-inch guidewire 1.17 0.05–11.23 0.901 Use of a balloon catheter for fistula dilation 1.58 0.29–9.51 0.600 Use of a metal stent 1.33 0.24–8.02 0.740 *Because all cases without clinical effectiveness were positive. ASA-PS, American Society of Anesthesiologists physical status; CI, confidence interval; ERCP, endoscopic retrograde cholangiopancreatography; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; NA, not available; OR, odds ratio; PS, performance status; PTBD, percutaneous transhepatic biliary drainage. Table 5 Multivariable analysis of factors associated with the clinical effectiveness of EUS-HDS in 31 patients with technically successful procedures. Independent variable OR 95%CI P value Cholangitis more than severe moderate 0.11 0.00–1.00 0.073 Biliary stent deployment before EUS-HDS 9.16 1.13–196.20 0.065 CI, confidence interval; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy; OR, odds ratio. Discussion Despite the good performance of EUS-HDS without severe adverse events in the present study, the technical success rate was about 10% lower than in two previous studies 12 , 13 . In those two studies, median patient age was more than 10 years older than in the present study and the median diameter of target bile ducts was 6.2 and 7.0 mm, respectively 12 , 13 . On the other hand, the diameters of targeted bile ducts in the four unsuccessful EUS-HDS cases in the present study were 2.8, 2.9, 3.0, and 5.2 mm. The small bile duct diameter might have contributed to technical failure; however, we cannot conclude this was the only reason because one case was abandoned due to an intervening vessel before puncture and one case suffered failure during stent placement although it was possible to proceed to the dilation part. Recently, the usefulness of a 0.018-inch guidewire and 22-gauge needle in EUS-BD procedures has been reported 16 , 17 . In the present study, these devices were used in three patients with bile duct diameters of 1.5, 3.3, and 4.7 mm, respectively, and successful stent deployment was achieved in these cases. Thus, a 0.018-inch guidewire and 22-gauge needle are expected to facilitate EUS-HDS in patients with mild bile duct dilatation. Ma et al. reported a better clinical success rate of 80% (28/35) in intention-to-treat analysis compared with the present study 12 . Cho et al. reported even higher clinical success rates in both intention-to-treat and per-protocol analyses (83% [15/18] and 88% [17/18]) 13 . Unlike the present study, metal stents were used in all patients with technical success in these studies 12 , 13 . A metal stent may be linked with clinical success; however, univariable analysis did not find a significant difference between metal and plastic stents in the present study (OR; 1.33, 95% CI; 0.24–8.02, P = 0.740). In addition, patency of metal and plastic stents did not significantly differ. However, it remains possible that the endosonographer's selection of the appropriate stent type, including size or length, for each case underlies the lack of a difference in clinical success and patency between plastic and metal stents. Multivariate analysis suggested that less severe than mild cholangitis and biliary stent deployment before EUS-HDS contribute to the efficacy of EUS-HDS. Some degree of controlled cholangitis by adequate biliary drainage other than bile ducts targeted by EUS-HDS might be a good indication of this procedure. In support of this, all cases in the study by Cho et al. had a history of biliary intervention, and metal stents were inserted into the intrahepatic bile duct prior to EUS-HDS, which might have led to the high clinical success rate of EUS-HDS 13 . Furthermore, Minaga et al. reported that a Bismuth type 4 stricture (i.e., cholangitis that is difficult to control) predicted clinical ineffectiveness (OR; 12.7, 95% CI; 1.18–135.4, P = 0.035) of EUS-guided intrahepatic biliary drainage for malignant hilar biliary stricture after failed ERCP 18 . Of note, that study mainly reported EUS-HGS, and the targeted bile ducts differed from those in the present study. A recent study points to the importance of bilateral biliary drainage when performing EUS-HDS 19 . Hijioka, et al. retrospectively reviewed combination procedures and simultaneously performed EUS-HGS and EUS-HDS in eight patients with Bismuth type 2–4, with technical and clinical success rates of 87.5% and 75.0%, respectively 19 . There were two case of mild peritonitis and six cases of recurrent biliary obstruction after the procedure, and median stent patency was 90 days (95% CI; 47.0–133 days) when last follow-up and death were censored. Generally, cases with segregated left and right intrahepatic bile ducts (i.e., Bismuth type 2–4) are considered prone to recurrence of cholangitis after biliary interventions. We believe that it is important to perform not only total hepatic biliary drainage at the time of EUS-HDS but also adequate re-intervention at the time of recurrent biliary obstruction to improve the outcome of EUS-HDS and achieve long-term stent patency. As in the cholangiocarcinoma case with perihilar biliary stenosis who underwent EUS-HDS after ERCP and EUS-HGS shown in Fig. 1 , it is essential to identify which bile duct is obstructed and what is the cause and to add a stent or replace the stent appropriately during the re-intervention. This case had multiple stenoses of intrahepatic bile ducts, but only one re-intervention was required during the 8 months between the date of EUS-HGS and transfer to the hospital for palliative care by performing biliary procedures via three routes (trans-papillary, EUS-HGS, and EUS-HDS). The present study has several limitations. First, it is a non-comparative retrospective study using a small number of patients. Second, the stent types used during EUS-HDS varied, although patency of plastic and metal stents was compared. Third, the clinical success of EUS-HDS may have been underestimated because many cases with biliary obstruction not within the therapeutic area of EUS-HDS were included. The significance of EUS-HDS prior to ERCP or EUS-HGS remains unclear, although a recent study showed the efficacy of simultaneously performing EUS-HGS and EUS-HDS as a first-step biliary intervention 19 . Finally, the results of multivariable analysis may be inaccurate because this analysis was perfomred after selecting factors with P values less than 0.2 in univariable analysis and the P values obtained in this analysis were not statistically significant and only indicated tendency. In conclusion, EUS-HDS is a feasible, safe, and effective method for intrahepatic bile duct drainage. EUS-HDS is expected to have a better therapeutic benefit when it is used in combination with other biliary interventions such as ERCP and EUS-HGS. Further prospective randomized trials using larger cohorts of patients are required to compare EUS-HDS with alternative treatments as a first- or second-step biliary intervention with respect to efficacy and safety. Abbreviations ASA-PS, American Society of Anesthesiologists physical status CI, confidence interval ENBD, endoscopic nasobiliary drainage ERCP, endoscopic retrograde cholangiopancreatography EUS, endoscopic ultrasonography EUS-BD, endoscopic ultrasound-guided biliary drainage EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy NA, not available OR, odds ratio PS, performance status PTBD, percutaneous transhepatic biliary drainage Declarations Conflict of interest: The authors have no potential conflicts of interest to declare. Funding support: No funding was received for conducting this study. Data availability: The datasets analyzed during the current study are available from the corresponding author on reasonable request. Author contribution Ken Kamata: Conceptualization, Methodology, Investigation, Formal Analysis, Resources, Writing - Original Draft; Mamoru Takenaka: Writing - Review & Editing; Atsushi Okuda, Takeshi Ogura, Yuzo Shimokawa, Akihisa Ohno, Nao Fujimori, Masahiro Itonaga, Masayuki Kitano, Kazuyuki Matsumoto, Koichiro Mandai, Hideyuki Shiomi, Ryota Sagami, Hajime Imai, Hirotsugu Maruyama, and Hideki Kamada: Resources. All authors have read and approved the manuscript. Disclosure Ken Kamata, Atsushi Okuda, Takeshi Ogura, Yuzo Shimokawa, Akihisa Ohno, Nao Fujimori, Masahiro Itonaga, Masayuki Kitano, Kazuyuki Matsumoto, Koichiro Mandai, Hideyuki Shiomi, Ryota Sagami, Hajime Imai, Hirotsugu Maruyama, Hideki Kamada, and Mamoru Takenaka have no conflict of interest or financial ties to disclose. References Imai H, Kitano M, Omoto S, et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. 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Endoscopic Ultrasound 2022; 11: 520–1 Ogura T, Okuda A, Ueno S, et al. EUS-guided hepaticojejunostomy using a 22G needle and novel 0.018-inchguidewire (with video). Endoscopic Ultrasound 2022; 11: 513–4 Minaga K, Takenaka M, Kitano M, et al. Rescue EUS-guided intrahepatic biliary drainage for malignant hilar biliary stricture after failed transpapillary re-intervention. Surg Endosc 2017; 31: 4764–772 Hijioka S, Nagashio Y, Maruki Y, et al. Novel approach to bilateral biliary drainage: EUS-guided hepaticoduodenostomy plus hepaticogastrostomy in malignant hilar biliary obstruction. Endosc Int Open 2025; 13: a25658206 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7698529","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":528228817,"identity":"ed516912-0bb4-4fcd-b863-6ef55b94e2f8","order_by":0,"name":"Ken Kamata","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8klEQVRIiWNgGAWjYBACCQbGhgMfCtBEDfBrYW48OMMASCMrJqCFvfkwD7oWvEByRmLDYRsDmzp+BuaDjwsq/jCYszcwFKO7FBlISwC15BikSUg2sCUbzzhjwGDZc4DBeAYeLXIQLYclDA7wmEnzthkwGNxIYDDmIaTFwuA/UAv/N2nef0At9x/g1wJ2GIPBAZAtbNK8DSBbGPBrkex52HCwxyBZcmYzm7ExzzFjHoMziQ14/SJxPP3xhx8Vdvz87M0PH/PUyMkZHD98zBhfiDEIJEAZzBAK6CTGNmN8Ohj4D2CKMT/Gq2UUjIJRMApGGgAADOlFUnF2bygAAAAASUVORK5CYII=","orcid":"","institution":"Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Ken","middleName":"","lastName":"Kamata","suffix":""},{"id":528228819,"identity":"6fe13bff-70fe-4fe3-8ad5-29d1bdcfed8f","order_by":1,"name":"Atsushi Okuda","email":"","orcid":"","institution":"2nd Department of Internal Medicine, Osaka Medical 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Gastroenterology, Hyogo Medical University","correspondingAuthor":false,"prefix":"","firstName":"Hideyuki","middleName":"","lastName":"Shiomi","suffix":""},{"id":528228836,"identity":"9b282ca5-231e-4f70-8ca6-f54ad2742d51","order_by":11,"name":"Ryota Sagami","email":"","orcid":"","institution":"Department of Advanced Gastrointestinal Cancer Medicine, Faculty of Medicine, Oita University","correspondingAuthor":false,"prefix":"","firstName":"Ryota","middleName":"","lastName":"Sagami","suffix":""},{"id":528228837,"identity":"97715cb1-c540-48f5-a0a3-372a843294e7","order_by":12,"name":"Hajime Imai","email":"","orcid":"","institution":"Department of Gastroenterology, Okanami General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hajime","middleName":"","lastName":"Imai","suffix":""},{"id":528228838,"identity":"ce1fbd34-937c-49d7-ab00-f7a2f85dcf77","order_by":13,"name":"Hirotsugu Maruyama","email":"","orcid":"","institution":"Department of Gastroenterology, Osaka Metropolitan 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1","display":"","copyAsset":false,"role":"figure","size":457679,"visible":true,"origin":"","legend":"\u003cp\u003e(a) Fluoroscopy image showing a straight-type plastic stent deployed in B8 by the trans-papillary approach and a partially covered metal stent placed in B3 by EUS-HGS prior to EUS-HDS for B6 using a Type-IT plastic stent. (b) Cholangiography during re-intervention showing dilated B6 and B8 due to the obstruction of plastic stents. (c) Cholangiography from the EUS-HGS route showing obstruction due to hyperplasia in the uncovered part of the metal stent. (d) Finally, two plastic stents were replaced with straight-type plastic stents, and an additional Type-IT plastic stent was deployed thought the metal stent placed via the EUS-HGS route.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7698529/v1/f6f5ff6469d062571e798e8d.png"},{"id":94987217,"identity":"e0bc6a74-ea2e-4a22-89b6-4577542a85f1","added_by":"auto","created_at":"2025-11-03 07:01:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1380819,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7698529/v1/a194b3e3-a939-4704-8811-2321b53fa2af.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eUtility of endoscopic ultrasound-guided hepaticoduodenostomy for intrahepatic bile duct drainage: a multicenter retrospective study in western Japan\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBiliary drainage procedures for biliary strictures includes percutaneous transhepatic biliary drainage (PTBD), endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultrasound-guided biliary drainage (EUS-BD). EUS-BD has been widely performed in recent years, especially at advanced facilities\u003csup\u003e\u003cspan additionalcitationids=\"CR2 CR3 CR4 CR5 CR6 CR7 CR8 CR9 CR10\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. The main procedural steps are puncture of the biliary tract, dilation of the puncture site, and placement of a stent, which allows one-stage internal biliary drainage. Stenting sites vary widely and include the left intrahepatic bile duct-stomach, right intrahepatic bile duct-duodenum, common bile duct-duodenum, and gallbladder-duodenum. Endoscopic ultrasonography-guided hepaticoduodenostomy (EUS-HDS) is relatively rarely used, but can be performed in cases of ERCP failure or as an alternative to PTBD. It has the advantage of being applicable to bile ducts of the right posterior segment; however, there are only a few reports regarding technical and clinical successes of this procedure using a small number of cases at single high-volume centers\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. The reasons for this are that there are few cases of trans-papillary approach failure or in which only the right posterior sectoral bile duct is responsible for cholangitis, and this procedure is difficult to perform in cases with duodenal stenosis. The aims of the present study were to evaluate the technical feasibility and clinical efficacy of EUS-HDS for intrahepatic bile duct drainage in a multicenter retrospective study, to explore in which cases this technique is performed in the real world, and to determine in which cases it is appropriate to perform this technique.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003ePatients\u003c/p\u003e\n\u003cp\u003eThis multicenter, non-controlled, retrospective study was approved by the Ethics Committee of the Kindai University Faculty of Medicine (number: R06-190). Consecutive patients who underwent EUS-HDS at one of 12 western Japanese referral centers between January 2010 and December 2024 were enrolled. Informed consent was obtained via opt-out on the website. All methods were performed in accordance with the relevant guidelines and regulations. The cut-off date for data analysis was April 4, 2025.\u003c/p\u003e\n\u003cp\u003eEUS-HDS\u003c/p\u003e\n\u003cp\u003eAll EUS-HDS procedure were performed by trained endoscopists. A conventional linear array echoendoscope (GF-UCT 260; Olympus) was used for EUS-HDS. The intrahepatic bile duct was depicted from the duodenal bulb on EUS and was punctured using a 19- or 22-gauge needle (EZ Shot3; Olympus or SonoTip; Medi-Globe) after confirming there were no intervening vessels above the puncture line using Doppler mode. After the tip of the puncture needle was confirmed to be in the intrahepatic bile duct by performing EUS and aspirating bile juice with a syringe, contrast medium was injected and 0.025- or 0.018-inch guidewires (Fielder; Asahi Intecc, VisiGlide2; Olympus, EndoSelector, Pathcourse, NovaGold, or VENTY; Boston Scientific, or J-WIRE; J-MIT) were inserted into the bile duct. The puncture site was dilated using contrast (Uneven Double Lumen Cannula; Piolax), dilation (ES dilator; Zeon, Soehendra; Cook, or Tornus; Asahi Intecc), a 3\u0026ndash;6-mm balloon catheter (REN; Kaneka), or electrocautery (Cysto-Gastro-Sets; ENDO-FLEX). In some cases, these methods were used in combination or dilation was not required. Thereafter, a 5\u0026ndash;7-Fr plastic (Harmo Ray; Hanaco, REGULUS; Japan Lifeline, or Type-IT; Gadelius) or 6\u0026ndash;10-mm metal (BileRush; Piolax, Niti-S or Spring Stopper; Taewoong, or Hanaro or WallFlex; Boston Scientific) stent was placed between the intrahepatic bile duct and duodenum, and it was confirmed that the stent was released into the bile duct on both EUS and fluoroscopy images. In some cases, endoscopic nasobiliary drainage was performed.\u003c/p\u003e\n\u003cp\u003eDefinitions\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAcute cholangitis and its severity were diagnosed according to the Tokyo guidelines\u003csup\u003e14\u003c/sup\u003e. Only confirmed cases were considered acute cholangitis. The primary endpoint was clinical success. The secondary endpoints were technical success, stent patency, and complications. Clinical success was defined as an improvement of the serum bilirubin level to less than 50% of that before treatment within 1 week after EUS-HDS or complete cure of clinical symptoms of cholangitis. To calculate clinical success rates, all cases and cases with technical success were used as denominators in the intention-to-treat and per-protocol analyses, respectively. Technical success was defined as successful deployment of the stent in the required position during EUS-HDS. The duration of stent patency was defined as the length of time between stent deployment and stent occlusion, removal, migration, or change other than routine stent replacement. Procedure-related adverse events and their severity were defined according to the recommendation of the American Society of Gastrointestinal Endoscopy\u003csup\u003e15\u003c/sup\u003e. Early procedural adverse events were defined as any adverse events due to EUS-HDS that developed within 2 weeks.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eStatistical analysis\u003c/p\u003e\n\u003cp\u003eResults are presented as the median with range or numbers with percentage and/or 95% confidence interval (CI). Stent patency was analyzed in all patients with technical success by the Kaplan-Meier method with the log-rank test. For this analysis,\u0026nbsp;calculations were performed by censoring death and the last follow-up date or treating them as events. Univariable and multivariable logistic regression analyses were performed to identify factors associated with the clinical effectiveness of EUS-HDS. The odds ratio (OR) and 95% CI were calculated. Variables with a P value \u0026lt;0.2 in univariable analysis were included in multivariable analysis. Effects were considered statistically significant at \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.05, and a P value between 0.05 and 0.1 was considered to indicate a tendency. Statistical analyses were performed using GraphPad Prism (GraphPad Software).\u0026nbsp;\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003ePatient characteristics\u003c/p\u003e\u003cp\u003eA total of 35 patients who underwent EUS-HDS during the study period were enrolled. Patient characteristics at baseline are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Of the 35 patients, 33 had primary malignancy and about half had cholangiocarcinoma (intrahepatic; n\u0026thinsp;=\u0026thinsp;3, peripheral; n\u0026thinsp;=\u0026thinsp;12, distal; n\u0026thinsp;=\u0026thinsp;3). Cholangitis was less severe than mild in most cases, and one of the 10 cases with moderate cholangitis was complicated by a liver abscess. Most patients had perihilar biliary stenosis with segregated left and right intrahepatic bile ducts; however, four patients underwent surgical resection of the left hepatic lobe. Nine patients received at least five biliary interventions, and only two patients had never received them before EUS-HDS regardless of success or non-success. The main causes of failed ERCP-mediated drainage of bile ducts targeted by EUS-HDS were a tight stricture (n\u0026thinsp;=\u0026thinsp;22), a previous stent mesh (n\u0026thinsp;=\u0026thinsp;5), and surgically altered anatomy (n\u0026thinsp;=\u0026thinsp;6). These patients included one patient in whom ERCP was not performed because of anticipated difficulty in penetrating the bile duct stricture and three patients in whom ERCP was not performed because of anticipated difficulty in reaching the bile duct orifice due to surgically altered anatomy. Twenty-four patients had undergone one or more stent deployments in any bile ducts that were not targeted by EUS-HDS, and the remaining 11 patients had not undergone stent deployment prior to EUS-HDS.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePatient characteristics at baseline (n\u0026thinsp;=\u0026thinsp;35)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex, n (%)\u003c/p\u003e\u003cp\u003eMale\u003c/p\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17 (48.6)\u003c/p\u003e\u003cp\u003e18 (51.4)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian age, years (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e76 (29\u0026ndash;89)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePerformance status, n (%)\u003c/p\u003e\u003cp\u003e0\u003c/p\u003e\u003cp\u003e1\u003c/p\u003e\u003cp\u003e2\u003c/p\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e15 (42.9)\u003c/p\u003e\u003cp\u003e14 (40.0)\u003c/p\u003e\u003cp\u003e5 (14.3)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAmerican Society of Anesthesiologists physical status, n (%)\u003c/p\u003e\u003cp\u003e0\u003c/p\u003e\u003cp\u003e1\u003c/p\u003e\u003cp\u003e2\u003c/p\u003e\u003cp\u003e3\u003c/p\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e4 (11.4)\u003c/p\u003e\u003cp\u003e20 (57.1)\u003c/p\u003e\u003cp\u003e4 (11.4)\u003c/p\u003e\u003cp\u003e6 (17.1)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian age-adjusted Charlson comorbidity index (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9 (0\u0026ndash;13)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrimary diseases, n (%)\u003c/p\u003e\u003cp\u003eHepatocellular carcinoma\u003c/p\u003e\u003cp\u003eCholangiocarcinoma\u003c/p\u003e\u003cp\u003eGallbladder cancer\u003c/p\u003e\u003cp\u003ePancreatic cancer\u003c/p\u003e\u003cp\u003eGastric cancer\u003c/p\u003e\u003cp\u003eColon cancer\u003c/p\u003e\u003cp\u003ePeritoneal cancer\u003c/p\u003e\u003cp\u003eHepaticojejunostomy anastomotic stricture\u003c/p\u003e\u003cp\u003eTraffic injury\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e18 (51.4)\u003c/p\u003e\u003cp\u003e4 (11.4)\u003c/p\u003e\u003cp\u003e2 (5.7)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e6 (17.1)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDegree of cholangitis, n (%)\u003c/p\u003e\u003cp\u003eAbsence\u003c/p\u003e\u003cp\u003eMild\u003c/p\u003e\u003cp\u003eModerate\u003c/p\u003e\u003cp\u003eSevere\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e8 (22.9)\u003c/p\u003e\u003cp\u003e17 (48.6)\u003c/p\u003e\u003cp\u003e10 (28.6)\u003c/p\u003e\u003cp\u003e0 (0)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLocation of biliary stenosis*, n (%)\u003c/p\u003e\u003cp\u003eDistal\u003c/p\u003e\u003cp\u003ePerihilar\u003c/p\u003e\u003cp\u003eRight intrahepatic\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e32 (91.4)\u003c/p\u003e\u003cp\u003e5 (14.3)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSegregated left and right intrahepatic bile ducts, n (%)\u003c/p\u003e\u003cp\u003ePresence\u003c/p\u003e\u003cp\u003eAbsence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e26 (74.3)\u003c/p\u003e\u003cp\u003e9 (25.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian number of biliary interventions before EUS-HDS\u003csup\u003e\u0026dagger;\u003c/sup\u003e, n (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (0\u0026ndash;11)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of PTBD, n (%)\u003c/p\u003e\u003cp\u003ePresence\u003c/p\u003e\u003cp\u003eAbsence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (14.3)\u003c/p\u003e\u003cp\u003e30 (85.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of ERCP, n (%)\u003c/p\u003e\u003cp\u003ePresence\u003c/p\u003e\u003cp\u003eAbsence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e30 (85.7)\u003c/p\u003e\u003cp\u003e5 (14.3)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of EUS-HGS, n (%)\u003c/p\u003e\u003cp\u003ePresence\u003c/p\u003e\u003cp\u003eAbsence\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12 (34.3)\u003c/p\u003e\u003cp\u003e23 (65.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCause of failed ERCP drainage prior to EUS-HDS, n (%)\u003c/p\u003e\u003cp\u003eBile duct cannulation failure\u003c/p\u003e\u003cp\u003eTight stricture\u003c/p\u003e\u003cp\u003ePrevious stent mesh\u003c/p\u003e\u003cp\u003eSurgically altered anatomy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (5.7)\u003c/p\u003e\u003cp\u003e22 (62.9)\u003c/p\u003e\u003cp\u003e5 (14.3)\u003c/p\u003e\u003cp\u003e6 (17.1)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNumber of stents deployed before EUS-HDS, n (%)\u003c/p\u003e\u003cp\u003e0\u003c/p\u003e\u003cp\u003e1\u003c/p\u003e\u003cp\u003eMultiple\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e11 (31.4)\u003c/p\u003e\u003cp\u003e8 (22.9)\u003c/p\u003e\u003cp\u003e16 (45.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eType of stent deployed before EUS-HDS\u003csup\u003e\u0026Dagger;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003ePlastic stent\u003c/p\u003e\u003cp\u003eMetal stent\u003c/p\u003e\u003cp\u003eBoth\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (25.0)\u003c/p\u003e\u003cp\u003e14 (58.3)\u003c/p\u003e\u003cp\u003e4 (16.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian interval from last drainage to EUS-HDS\u003csup\u003e\u0026sect;\u003c/sup\u003e, days (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e17 (1\u0026ndash;197)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e*There were duplicate cases. \u003csup\u003e\u0026dagger;\u003c/sup\u003eCalculated by including non-successful cases. \u003csup\u003e\u0026Dagger;\u003c/sup\u003eThe percentage was calculated using 24 cases with stent deployment as the denominator. \u003csup\u003e\u0026sect;\u003c/sup\u003eCalculated using 24 cases with stent deployment before EUS-HDS.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eERCP, endoscopic retrograde cholangiopancreatography; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; PTBD, percutaneous transhepatic biliary drainage.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eProcedure details and outcomes of EUS-HDS\u003c/p\u003e\u003cp\u003eProcedure details of EUS-HDS are shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The median procedure duration was 35 minutes, and the shortest procedure duration among successful cases was 10 min. The technical success rate was 88.6% (95% CI; 73.5\u0026ndash;96.1%). In one case, the bile duct could not be punctured due to an intervening vessel. In two cases, the guidewires only peaked at the peripheral bile ducts and the procedures were abandoned at the preliminary stage of dilatation of the puncture site. In one case, the puncture site was not dilated properly and stent placement was not possible. The main puncture sites were B6 and B7. Plastic and metal stents were used in 16 and 15 patients, respectively. Stent size and length were appropriately chosen for each case and varied.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eProcedure details of EUS-HDS (n\u0026thinsp;=\u0026thinsp;35)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian diameter of target bile duct on EUS, mm (range)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5.0 (1.5\u0026ndash;9.2)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian procedure duration, min (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e35 (8\u0026ndash;245)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTechnical success, n (% [95% CI])\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e31 (88.6 [73.5\u0026ndash;96.1])\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFailure phase*, n (%)\u003c/p\u003e\u003cp\u003ePuncture\u003c/p\u003e\u003cp\u003eDilation\u003c/p\u003e\u003cp\u003eStent deployment\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (25.0)\u003c/p\u003e\u003cp\u003e2 (50.0)\u003c/p\u003e\u003cp\u003e1 (25.0)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePuncture site\u003csup\u003e\u0026dagger;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003eB1\u003c/p\u003e\u003cp\u003eB5\u003c/p\u003e\u003cp\u003eB6\u003c/p\u003e\u003cp\u003eB7\u003c/p\u003e\u003cp\u003eB8\u003c/p\u003e\u003cp\u003eDetail unknown\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e2 (5.9)\u003c/p\u003e\u003cp\u003e22 (64.7)\u003c/p\u003e\u003cp\u003e6 (17.6)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003cp\u003e2 (5.9)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSize of puncture needle\u003csup\u003e\u0026dagger;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003e19-gauge\u003c/p\u003e\u003cp\u003e22-gauge\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e30 (88.2)\u003c/p\u003e\u003cp\u003e4 (11.8)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSize of guidewire\u003csup\u003e\u0026dagger;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003e0.025-inch\u003c/p\u003e\u003cp\u003e0.018-inch\u003c/p\u003e\u003cp\u003eDetail unknown\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e30 (88.2)\u003c/p\u003e\u003cp\u003e3 (8.8)\u003c/p\u003e\u003cp\u003e1 (2.9)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMethod of fistula dilatation\u003csup\u003e\u0026Dagger;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003eContrast catheter\u003c/p\u003e\u003cp\u003eDilation catheter\u003c/p\u003e\u003cp\u003eBalloon catheter\u003c/p\u003e\u003cp\u003eDilation plus balloon catheter\u003c/p\u003e\u003cp\u003eElectrocautery\u003c/p\u003e\u003cp\u003eNot required\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (9.4)\u003c/p\u003e\u003cp\u003e9 (28.1)\u003c/p\u003e\u003cp\u003e12 (37.5)\u003c/p\u003e\u003cp\u003e5 (15.6)\u003c/p\u003e\u003cp\u003e1 (3.1)\u003c/p\u003e\u003cp\u003e2 (6.3)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eType of stent\u003csup\u003e\u0026sect;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003ePlastic stent\u003c/p\u003e\u003cp\u003eMetal stent\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e16 (51.6)\u003c/p\u003e\u003cp\u003e15 (48.4)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSize of stent\u003csup\u003e\u0026sect;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003ePlastic stent\u003c/p\u003e\u003cp\u003e5 Fr\u003c/p\u003e\u003cp\u003e6 Fr\u003c/p\u003e\u003cp\u003e7 Fr\u003c/p\u003e\u003cp\u003eDetail unknown\u003c/p\u003e\u003cp\u003eMetal stent\u003c/p\u003e\u003cp\u003e6 mm\u003c/p\u003e\u003cp\u003e8 mm\u003c/p\u003e\u003cp\u003e10 mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003cp\u003e2 (6.5)\u003c/p\u003e\u003cp\u003e12 (38.7)\u003c/p\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003cp\u003e2 (6.5)\u003c/p\u003e\u003cp\u003e9 (29.0)\u003c/p\u003e\u003cp\u003e4 (12.9)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLength of stent\u003csup\u003e\u0026sect;\u003c/sup\u003e, n (%)\u003c/p\u003e\u003cp\u003ePlastic stent\u003c/p\u003e\u003cp\u003e7 cm\u003c/p\u003e\u003cp\u003e10 cm\u003c/p\u003e\u003cp\u003e12 cm\u003c/p\u003e\u003cp\u003e14 cm\u003c/p\u003e\u003cp\u003eENBD\u003c/p\u003e\u003cp\u003eDetail unknown\u003c/p\u003e\u003cp\u003eMetal stent\u003c/p\u003e\u003cp\u003e6 cm\u003c/p\u003e\u003cp\u003e8 cm\u003c/p\u003e\u003cp\u003e10 cm\u003c/p\u003e\u003cp\u003e12 cm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2 (6.5)\u003c/p\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003cp\u003e8 (25.8)\u003c/p\u003e\u003cp\u003e3 (9.7)\u003c/p\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003cp\u003e1 (3.2)\u003c/p\u003e\u003cp\u003e8 (25.8)\u003c/p\u003e\u003cp\u003e3 (9.7)\u003c/p\u003e\u003cp\u003e3 (9.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e*The percentage was calculated using four cases with failure as the denominator. \u003csup\u003e\u0026dagger;\u003c/sup\u003eThe percentage was calculated using 34 cases with puncture as the denominator. \u003csup\u003e\u0026Dagger;\u003c/sup\u003eThe percentage was calculated using 32 cases with dilation as the denominator. \u003csup\u003e\u0026sect;\u003c/sup\u003eThe percentage was calculated using 31 cases with stent deployment as the denominator.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eCI, confidence interval; ENBD, endoscopic nasobiliary drainage; EUS, endoscopic ultrasonography; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eOutcomes after EUS-HDS are shown in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. The clinical success rate in the intention-to-treat and per-protocol analyses was 68.6% (95% CI; 51.9\u0026ndash;81.6%) and 77.4% (95% CI; 59.9\u0026ndash;88.9%), respectively. There was one case of peritonitis, which was an early procedural adverse event. Of the 21 patients who required re-intervention after EUS-HDS, the EUS-HDS route was used in 12 patients. These 12 patients included two who underwent routine stent replacement. Median stent patency with last follow-up and death censored and treated as events was 285 (6\u0026ndash;999) days and 77 (6\u0026ndash;999) days, respectively. Patency of plastic and metal stents did not significantly differ in analyses with last follow-up and death censored (238.0 vs. 285.0 days, P\u0026thinsp;=\u0026thinsp;0.117) and treated as events (64.5 vs. 77.0 days, P\u0026thinsp;=\u0026thinsp;0.455). Excluding patients with technical failure, factors predicting the clinical effectiveness of EUS-HDS were compared between the 24 patients with clinical success and the seven patients with clinical failure. Univariable analysis showed that cholangitis more severe than moderate and biliary stent deployment before EUS-HDS were candidate factors related to clinical effectiveness (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Multivariable analysis revealed that cholangitis more severe than moderate and biliary stent deployment before EUS-HDS tended to be negatively (OR; 0.11, 95% CI; 0.00\u0026ndash;1.00, P\u0026thinsp;=\u0026thinsp;0.073) and positively (OR; 9.16, 95% CI; 1.13\u0026ndash;196.20, P\u0026thinsp;=\u0026thinsp;0.065) associated with clinical success of EUS-HDS, respectively (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eOutcomes after EUS-HDS (n\u0026thinsp;=\u0026thinsp;35)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eClinical success, n/N (% [95%CI])\u003c/p\u003e\u003cp\u003eIntention-to-treat analysis\u003c/p\u003e\u003cp\u003ePer-protocol analysis\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003e24/35 (68.6 [51.9\u0026ndash;81.6])\u003c/p\u003e\u003cp\u003e24/31 (77.4 [59.9\u0026ndash;88.9])\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEarly procedural adverse events, n (%[95%CI])\u003c/p\u003e\u003cp\u003eMild\u003c/p\u003e\u003cp\u003eModerate\u003c/p\u003e\u003cp\u003eSevere\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (2.9 [-0.8\u0026ndash;15.8])\u003c/p\u003e\u003cp\u003e0\u003c/p\u003e\u003cp\u003e0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRe-intervention rate*, n/N (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e21/35 (60.0)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFrequency of re-interventions, n (%)\u003c/p\u003e\u003cp\u003e0\u003c/p\u003e\u003cp\u003e1\u003c/p\u003e\u003cp\u003e2\u003c/p\u003e\u003cp\u003eMore than 3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e16 (45.7)\u003c/p\u003e\u003cp\u003e6 (17.1)\u003c/p\u003e\u003cp\u003e3 (8.6)\u003c/p\u003e\u003cp\u003e10 (28.6)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRe-intervention rate using the EUS-HDS route\u003csup\u003e\u0026dagger;\u003c/sup\u003e, n/N (%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12/31 (38.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian stent patency*, days (range)\u003c/p\u003e\u003cp\u003eLast follow-up or death censored\u003c/p\u003e\u003cp\u003eLast follow-up or death treated as an event\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e285 (6\u0026ndash;999)\u003c/p\u003e\u003cp\u003e77 (6\u0026ndash;999)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian follow-up duration, days (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e131 (6\u0026ndash;999)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e*Includes all biliary drainage treatments performed after EUS-HDS. \u003csup\u003e\u0026dagger;\u003c/sup\u003eCalculated using 31 cases with technical success.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003eCI, confidence interval; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eUnivariable analysis of factors associated with the clinical effectiveness of EUS-HDS in 31 patients with technically successful procedures.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndependent variable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e95% CI\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.63\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.11\u0026ndash;3.49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.600\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOlder than 76 years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.24\u0026ndash;8.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.740\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePS 2 or higher\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.05\u0026ndash;3.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.322\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eASA-PS 3 or higher\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.03\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.17\u0026ndash;8.38\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.976\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharlson comorbidity index 9 or higher\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.63\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.11\u0026ndash;3.49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.600\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHepatobiliary pancreatic cancer\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.82\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.30\u0026ndash;10.55\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.499\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCholangitis more severe than moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.04\u0026ndash;1.77\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.160\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBiliary stenosis of the hepatic hilum\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNA*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNA*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNA*\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSegregated left and right intrahepatic bile ducts\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.02\u0026ndash;3.03\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.439\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAt least two previous biliary interventions before EUS-HDS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2.67\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.48\u0026ndash;16.51\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.264\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of PTBD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.36\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.05\u0026ndash;3.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.322\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of ERCP\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2.80\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.31\u0026ndash;21.96\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.322\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHistory of EUS-HGS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.41\u0026ndash;61.75\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.345\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSurgically altered anatomy the cause of ERCP failure\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.50\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.07\u0026ndash;4.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.488\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBiliary stent deployment before EUS-HDS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.70\u0026ndash;25.86\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.123\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMetal stent deployment before EUS-HDS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.24\u0026ndash;8.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.740\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiameter of target bile duct larger than 5mm\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.05\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.17\u0026ndash;5.83\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.955\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProcedure time longer than 35 min\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0.40\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.05\u0026ndash;2.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.325\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePuncture site B6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.36\u0026ndash;13.42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.366\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of a 19-gauge puncture needle\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.05\u0026ndash;11.23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.901\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of a 0.025-inch guidewire\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.05\u0026ndash;11.23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.901\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of a balloon catheter for fistula dilation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.29\u0026ndash;9.51\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.600\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUse of a metal stent\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0.24\u0026ndash;8.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.740\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003e*Because all cases without clinical effectiveness were positive.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eASA-PS, American Society of Anesthesiologists physical status; CI, confidence interval; ERCP, endoscopic retrograde cholangiopancreatography; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; NA, not available; OR, odds ratio; PS, performance status; PTBD, percutaneous transhepatic biliary drainage.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eMultivariable analysis of factors associated with the clinical effectiveness of EUS-HDS in 31 patients with technically successful procedures.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndependent variable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e95%CI\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCholangitis more than severe moderate\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.11\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.00\u0026ndash;1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.073\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBiliary stent deployment before EUS-HDS\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e9.16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1.13\u0026ndash;196.20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.065\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eCI, confidence interval; EUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy; OR, odds ratio.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eDespite the good performance of EUS-HDS without severe adverse events in the present study, the technical success rate was about 10% lower than in two previous studies\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. In those two studies, median patient age was more than 10 years older than in the present study and the median diameter of target bile ducts was 6.2 and 7.0 mm, respectively\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. On the other hand, the diameters of targeted bile ducts in the four unsuccessful EUS-HDS cases in the present study were 2.8, 2.9, 3.0, and 5.2 mm. The small bile duct diameter might have contributed to technical failure; however, we cannot conclude this was the only reason because one case was abandoned due to an intervening vessel before puncture and one case suffered failure during stent placement although it was possible to proceed to the dilation part. Recently, the usefulness of a 0.018-inch guidewire and 22-gauge needle in EUS-BD procedures has been reported\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. In the present study, these devices were used in three patients with bile duct diameters of 1.5, 3.3, and 4.7 mm, respectively, and successful stent deployment was achieved in these cases. Thus, a 0.018-inch guidewire and 22-gauge needle are expected to facilitate EUS-HDS in patients with mild bile duct dilatation. Ma et al. reported a better clinical success rate of 80% (28/35) in intention-to-treat analysis compared with the present study\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Cho et al. reported even higher clinical success rates in both intention-to-treat and per-protocol analyses (83% [15/18] and 88% [17/18])\u003csup\u003e13\u003c/sup\u003e. Unlike the present study, metal stents were used in all patients with technical success in these studies\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. A metal stent may be linked with clinical success; however, univariable analysis did not find a significant difference between metal and plastic stents in the present study (OR; 1.33, 95% CI; 0.24\u0026ndash;8.02, P\u0026thinsp;=\u0026thinsp;0.740). In addition, patency of metal and plastic stents did not significantly differ. However, it remains possible that the endosonographer's selection of the appropriate stent type, including size or length, for each case underlies the lack of a difference in clinical success and patency between plastic and metal stents.\u003c/p\u003e\u003cp\u003eMultivariate analysis suggested that less severe than mild cholangitis and biliary stent deployment before EUS-HDS contribute to the efficacy of EUS-HDS. Some degree of controlled cholangitis by adequate biliary drainage other than bile ducts targeted by EUS-HDS might be a good indication of this procedure. In support of this, all cases in the study by Cho et al. had a history of biliary intervention, and metal stents were inserted into the intrahepatic bile duct prior to EUS-HDS, which might have led to the high clinical success rate of EUS-HDS\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Furthermore, Minaga et al. reported that a Bismuth type 4 stricture (i.e., cholangitis that is difficult to control) predicted clinical ineffectiveness (OR; 12.7, 95% CI; 1.18\u0026ndash;135.4, P\u0026thinsp;=\u0026thinsp;0.035) of EUS-guided intrahepatic biliary drainage for malignant hilar biliary stricture after failed ERCP\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. Of note, that study mainly reported EUS-HGS, and the targeted bile ducts differed from those in the present study. A recent study points to the importance of bilateral biliary drainage when performing EUS-HDS\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. Hijioka, et al. retrospectively reviewed combination procedures and simultaneously performed EUS-HGS and EUS-HDS in eight patients with Bismuth type 2\u0026ndash;4, with technical and clinical success rates of 87.5% and 75.0%, respectively\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. There were two case of mild peritonitis and six cases of recurrent biliary obstruction after the procedure, and median stent patency was 90 days (95% CI; 47.0\u0026ndash;133 days) when last follow-up and death were censored. Generally, cases with segregated left and right intrahepatic bile ducts (i.e., Bismuth type 2\u0026ndash;4) are considered prone to recurrence of cholangitis after biliary interventions. We believe that it is important to perform not only total hepatic biliary drainage at the time of EUS-HDS but also adequate re-intervention at the time of recurrent biliary obstruction to improve the outcome of EUS-HDS and achieve long-term stent patency. As in the cholangiocarcinoma case with perihilar biliary stenosis who underwent EUS-HDS after ERCP and EUS-HGS shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, it is essential to identify which bile duct is obstructed and what is the cause and to add a stent or replace the stent appropriately during the re-intervention. This case had multiple stenoses of intrahepatic bile ducts, but only one re-intervention was required during the 8 months between the date of EUS-HGS and transfer to the hospital for palliative care by performing biliary procedures via three routes (trans-papillary, EUS-HGS, and EUS-HDS).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThe present study has several limitations. First, it is a non-comparative retrospective study using a small number of patients. Second, the stent types used during EUS-HDS varied, although patency of plastic and metal stents was compared. Third, the clinical success of EUS-HDS may have been underestimated because many cases with biliary obstruction not within the therapeutic area of EUS-HDS were included. The significance of EUS-HDS prior to ERCP or EUS-HGS remains unclear, although a recent study showed the efficacy of simultaneously performing EUS-HGS and EUS-HDS as a first-step biliary intervention\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. Finally, the results of multivariable analysis may be inaccurate because this analysis was perfomred after selecting factors with P values less than 0.2 in univariable analysis and the P values obtained in this analysis were not statistically significant and only indicated tendency. In conclusion, EUS-HDS is a feasible, safe, and effective method for intrahepatic bile duct drainage. EUS-HDS is expected to have a better therapeutic benefit when it is used in combination with other biliary interventions such as ERCP and EUS-HGS. Further prospective randomized trials using larger cohorts of patients are required to compare EUS-HDS with alternative treatments as a first- or second-step biliary intervention with respect to efficacy and safety.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eASA-PS, American Society of Anesthesiologists physical status\u003c/p\u003e\n\u003cp\u003eCI, confidence interval\u003c/p\u003e\n\u003cp\u003eENBD, endoscopic nasobiliary drainage\u003c/p\u003e\n\u003cp\u003eERCP, endoscopic retrograde cholangiopancreatography\u003c/p\u003e\n\u003cp\u003eEUS, endoscopic ultrasonography\u003c/p\u003e\n\u003cp\u003eEUS-BD, endoscopic ultrasound-guided biliary drainage\u003c/p\u003e\n\u003cp\u003eEUS-HDS, endoscopic ultrasound-guided hepaticoduodenostomy\u003c/p\u003e\n\u003cp\u003eEUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy\u003c/p\u003e\n\u003cp\u003eNA, not available\u003c/p\u003e\n\u003cp\u003eOR, odds ratio\u003c/p\u003e\n\u003cp\u003ePS, performance status\u003c/p\u003e\n\u003cp\u003ePTBD, percutaneous transhepatic biliary drainage\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eConflict of interest:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors have no potential conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003eFunding support:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNo funding was received for conducting this study.\u003c/p\u003e\n\u003cp\u003eData availability:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe datasets analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003eAuthor contribution\u003c/p\u003e\n\u003cp\u003eKen Kamata: Conceptualization, Methodology, Investigation, Formal Analysis, Resources, Writing - Original Draft; Mamoru Takenaka: Writing - Review \u0026amp; Editing; Atsushi Okuda, Takeshi Ogura, Yuzo Shimokawa, Akihisa Ohno, Nao Fujimori, Masahiro Itonaga, Masayuki Kitano, Kazuyuki Matsumoto, Koichiro Mandai, Hideyuki Shiomi, Ryota Sagami, Hajime Imai, Hirotsugu Maruyama, and Hideki Kamada: Resources. All authors have read and approved the manuscript.\u003c/p\u003e\n\u003cp\u003eDisclosure\u003c/p\u003e\n\u003cp\u003eKen Kamata, Atsushi Okuda, Takeshi Ogura, Yuzo Shimokawa, Akihisa Ohno, Nao Fujimori, Masahiro Itonaga, Masayuki Kitano, Kazuyuki Matsumoto, Koichiro Mandai, Hideyuki Shiomi, Ryota Sagami, Hajime Imai, Hirotsugu Maruyama, Hideki Kamada, and Mamoru Takenaka\u003csup\u003e\u0026nbsp;\u003c/sup\u003ehave no conflict of interest or financial ties to disclose.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eImai H, Kitano M, Omoto S, et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointest Endosc 2016; 84: 147\u0026ndash;51\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKamata K, Takenaka M, Kitano M, et al. Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis: Long-term outcomes after removal of a self-expandable metal stent. World J Gastroenterol 2017; 23: 661\u0026ndash;7\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOgura T, Onda S, Takagi W, et al. Clinical utility of endoscopic ultrasound-guided biliary drainage as a rescue of re-intervention procedure for high-grade hilar stricture. J Gastroenterol Hepatol 2017; 32: 163\u0026ndash;8\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMinaga K, Ogura T, Shiomi H, et al. Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction: Multicenter, randomized, clinical trial. Dig Endosc 2019; 31: 575\u0026ndash;82\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKato H, Matsumoto K, and Okada H. Recent advances regarding endoscopic biliary drainage for unresectable malignant hilar biliary obstruction. DEN Open 2021; 2: e33\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eItonaga M, Kitano M, and Ashida R. Development of devices for interventional endoscopic ultrasound for the management of pancreatobiliary diseases. Dig Endosc 2023; 35: 302\u0026ndash;13\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSagami R, Mizukami K, Okamoto K, et al. Experience-Related Factors in the Success of Beginner Endoscopic Ultrasound-Guided Biliary Drainage: A Multicenter Study. J Clin Med 2023; 12: 2393\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMaruyama H, Ishikawa-Kakiya Y, Tanoue K, et al. Preloading guidewire method: EUS-guided hepaticogastrostomy. Arab J Gastroenterol 2023; 24: 183\u0026ndash;5\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKoga T, Ishida Y, Hashigo S, et al. Feasibility and safety of EUS-guided biliary drainage in inexperienced centers: a multicenter study in southwest Japan. Gastrointest Endosc 2025; 101: 843\u0026ndash;52\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eShiomi H. Current status of endoscopic ultrasound-guided antegrade stone removal for patients with a surgically altered anatomy. Dig Endosc 2022; 34: 82\u0026ndash;4\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMandai K, Inoue T, Shinomiya R, et al. Safety of early oral intake after endoscopic ultrasound-guided hepaticoenterostomy. Surg Endosc 2023; 37: 3449\u0026ndash;54\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMa KW, So H, Cho DH, et al. Durability and outcome of endoscopic ultrasound-guided hepaticoduodenostomy using a fully covered metal stent for segregated right intrahepatic duct dilatation. J Gastroenterol Hepatol 2020; 35: 1753\u0026ndash;60\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCho SH, Song TJ, Oh D, et al. Endoscopic ultrasound-guided hepaticoduodenostomy versus percutaneous drainage for right intrahepatic duct dilatation in malignant hilar obstruction. J Gastroenterol Hepatol 2024; 39: 552\u0026ndash;9\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKiriyama S, Kozaka K, Takeda T, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholantitis (with videos). J Hepatobiliary Pancreat Sci 2018; 25: 17\u0026ndash;30\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCotton PB, Eisen GM, Abakken L, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446\u0026ndash;54\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTakenaka M, Omoto S, Kudo M. EUS-guided drainage of the gallbladder using a novel 0.018-inch guidewire for preventing bile leakage (with video). Endoscopic Ultrasound 2022; 11: 520\u0026ndash;1\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOgura T, Okuda A, Ueno S, et al. EUS-guided hepaticojejunostomy using a 22G needle and novel 0.018-inchguidewire (with video). Endoscopic Ultrasound 2022; 11: 513\u0026ndash;4\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMinaga K, Takenaka M, Kitano M, et al. Rescue EUS-guided intrahepatic biliary drainage for malignant hilar biliary stricture after failed transpapillary re-intervention. Surg Endosc 2017; 31: 4764\u0026ndash;772\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHijioka S, Nagashio Y, Maruki Y, et al. Novel approach to bilateral biliary drainage: EUS-guided hepaticoduodenostomy plus hepaticogastrostomy in malignant hilar biliary obstruction. Endosc Int Open 2025; 13: a25658206\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"biliary, cholangiocarcinoma, drainage, endosonography, jaundice ","lastPublishedDoi":"10.21203/rs.3.rs-7698529/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7698529/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: There are several biliary drainage procedures for biliary strictures, including endoscopic ultrasound-guided hepaticoduodenostomy (EUS-HDS). However, only a few studies have investigated the technical and clinical success of this procedure with a small number of cases at single high-volume centers. Objective: This multicenter, non-controlled, retrospective study evaluated the safety and efficacy of EUS-HDS for intrahepatic bile duct drainage.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: Consecutive patients who underwent EUS-HDS at one of 12 Japanese referral centers between January 2010 and December 2024 were enrolled. The primary endpoint was clinical success. The secondary endpoints were technical success, stent patency, and complications.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: A total of 35 eligible patients were analyzed. Perihilar biliary stenosis was observed in 32 of 35 patients (91.4%) and right posterior sectoral bile ducts were targeted by EUS-HDS in 28 of 35 patients (80.0%). Technical success was achieved in 31 of 35 patients (88.6%) and clinical success was achieved in 24 of 31 patients (77.4%) according to per-protocol analysis. Median stent patency was 285 (6–999) days. An early procedural adverse event (mild peritonitis) occurred in one case. Patency did not significantly differ between plastic and metal stents (P=0.117). In multivariable analysis, less severe than mild cholangitis (P=0.073) and biliary stent deployment before EUS-HDS (P=0.065) tended to predict clinical effectiveness.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: EUS-HDS may be a feasible and effective treatment, especially for cases with some degree of controlled cholangitis achieved by adequate biliary drainage other than bile ducts targeted by EUS-HDS.\u003c/p\u003e","manuscriptTitle":"Utility of endoscopic ultrasound-guided hepaticoduodenostomy for intrahepatic bile duct drainage: a multicenter retrospective study in western Japan","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-15 09:16:18","doi":"10.21203/rs.3.rs-7698529/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"80191dcd-fae7-4519-9a89-c35945ad1a4a","owner":[],"postedDate":"October 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-11-01T15:38:31+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-15 09:16:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7698529","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7698529","identity":"rs-7698529","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}