Thin delivery stents can obviate the need for additional fistula dilatation of large diameter in endoscopic ultrasound-guided hepaticogastrostomy

Thin delivery stents can obviate the need for additional fistula dilatation of large diameter in endoscopic ultrasound-guided hepaticogastrostomy | 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 Thin delivery stents can obviate the need for additional fistula dilatation of large diameter in endoscopic ultrasound-guided hepaticogastrostomy Tomoki Ogata, Yusuke Kurita, Takamitsu Sato, Shin Yagi, Sho Hasegawa, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4016211/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) often requires fistula dilation owing to the placement of large diameter of the delivery stent. The recently developed delivery devices as thin as 5.9/6.0 Fr may save the need for fistula dilation. Therefore, we investigated whether the large fistula dilation would be required or not in case of this newly developed thin diameter delivery stents. Methods We conducted a retrospective study involving 33 patients implemented with self-expandable metal stent (SEMS) during EUS-HGS. The patients were categorized based on the delivery device diameter into thin (n = 13; delivery device diameter: 5.9/6.0 Fr) and thick (n = 20; delivery device diameter: 8.5 Fr) groups. We compared the initial rate of success, technical success, and clinical success between the thin and thick groups. Initial rate of success was defined as successful stent placement without a balloon or large diameter mechanical dilation. Results The rate of initial stenting success was significantly higher in the thin group (100% [13/13]) compared with that in the thick group (65.0% [13/20]) (p = 0.027). In the thick group, seven cases with technical difficulty in stent placement could be successfully completed with additional fistula dilation with 9Fr bougie dilator, or 4mm balloon dilator; this resulted in a technical success of 100% in both groups ultimately. The rate of clinical success was 100% and 95.0% in the thin and thick groups, respectively (p = 1.00). Conclusions Thin-delivery stents may facilitate stent placement without the need for a balloon fistula or large-diameter mechanical dilation. biliary obstruction endoscopic ultrasound hepaticogastrostomy thin delivery stents fistula dilation Figures Figure 1 Figure 2 Figure 3 Introduction Recently, endoscopic ultrasound-guided hepatogastrostomy (EUS-HGS) has been performed for biliary obstruction in cases of failed transpapillary drainage in recent years [ 1 – 5 ]. The safety of EUS-HGS has been previously reported. However, there are some adverse events could be taken place [ 6 – 12 ]. EUS-HGS are composed of various steps for the success, fistula dilation is one of important technique, as some patients have difficulty with dilating the stomach wall or intrahepatic bile duct [ 6 , 9 , 13 , 14 ]. Notably, conventional metal stents may require balloon fistula dilation or mechanical dilation of a large diameter in addition to mechanical dilation to implant an 8.5Fr self-expandable metal stent (SEMS) with such a thick delivery [ 15 ]. Despite the high technical success rates for EUS-HGS, few dedicated devices are available, and this technique has not yet been established as a standard practice. The use of thin delivery stents (5.9Fr or 6Fr) is expected to make it easier for the endoscopist to insert the stent [ 16 , 17 ]. Although there have been cases where the thick delivery stent required balloon fistula dilation or 9 Fr mechanical dilation, thin delivery stents may be inserted without the need for additional dilation. However, the need for balloon fistula or mechanical dilation of a large diameter before inserting in thin and thick diameter delivery stents has not been fully explored. Therefore, we compared the need for large fistula dilation using thin and thick delivery stents. Methods Patients This is a retrospective cohort case study. The patients who underwent EUS-HGS were included Yokohama City University Hospital between April 2015 and January 2023. The inclusion criteria were: 1) patients who had a metal stent implanted at the time of EUS-HGS, and the exclusion criteria were 1) patients who had a plastic stent implanted and 2) patients who had balloon fistula dilatation, or larger diameter bougie catheter ( ≧ 9 Fr) before initial metal stenting (Fig. 1 ). For comparison, patients were divided into thin delivery stent (thin group) and thick delivery stent (thick group) groups based on the stent delivery system at our institution, EUS-HGS is indicated when bile duct intubation is impossible or when reaching the duodenal papilla is not possible due to obstruction of the gastric or surgical anatomical changes outlet. The present study was approved by the institutional review board of Yokohama City University Hospital (B200600003, approved on 1 May 2020). Only medical information was used in this retrospective observational study, and participants privacy was not compromised. All patients provided informed consent and were included in the study. Procedures of EUS-HGS EUS-HGS was performed in all cases by experienced endoscopists specialized in EUS-guided procedures. The standard procedure of EUS-HGS used at our hospital is as follows: The endoscopic ultrasound (EU-ME2 or EU-ME1; Olympus, Tokyo, Japan, and GF-UCT260) was performed from the stomach to show the left intrahepatic bile duct (segment 2: B2 or segment 3: B3). A 19 G needle or a 22 G needle (Sono Tip Pro Control; Medi-Globe GmbH, Rosenheim, Germany; Expect; Boston Scientific, Boston, MA, USA; or, EZ shot 3 plus; Olympus, Tokyo, Japan) was used to puncture the left intrahepatic bile duct. After puncturing the intrahepatic bile duct, and aspirating bile juice, the bile duct was confirmed to be a bile duct by contrast. A guidewire (VisiGlide2 Olympus, Tokyo, Japan), or a Fielder 18 (Asahi Intec, Aichi, Japan) were inserted into the intrahepatic bile duct. Tract dilation from stomach to bile duct was conducted using a 7 Fr bougie dilation catheter (ES dilator; Zeon Medical Co., Ltd., Tokyo, Japan, or Soehendra Biliary Dilation Catheter; Cook Japan, Tokyo, Japan). After the tract bougie dilation, SEMS was inserted, with a stent diameter of either 6 mm or 8 mm and a length of 10 cm or 12 cm. The thin delivery stents (thin group) were placed using a delivery device with a diameter of 5.9 Fr (HANAROSTENT Biliary Full Cover Benefit; Boston Scientific, Boston, USA) or 6 Fr (EGIS Biliary Full Cover Stent; SB-KAWASUMI, Kanagawa, Japan). Thick delivery stents (thick group) were placed using 8.5 Fr delivery stents (Niti-S S-type biliary stents; Taewoong Medical, Seoul, Korea, and HANAROSTENT Biliary Full Cover; Boston Scientific, Boston, USA) (Fig. 2 ). In cases where SEMS insertion was unsuccessful after initial dilation using 7 Fr bougie dilation catheter, additional dilatation was performed using a balloon catheter (REN biliary dilation catheter; 4 mm) or a large diameter bougie catheter (Soehendra Biliary Dilation Catheter; 9 Fr in diameter). Endpoints The primary endpoint was to compare the rate of initial stenting success between the thin and thick stent groups. Initial stenting success was defined as cases in which stenting was possible with 7 Fr mechanical fistula dilation alone, without balloon dilation of the fistula or a large diameter bougie catheter (< 9 Fr). In cases where initial stenting was unsuccessful, additional fistula dilation was conducted using a balloon catheter or a large mechanical catheter (9 Fr) depend on the situation. The secondary endpoints were the rate of technical success, the rate of clinical success, time to recurrent biliary obstruction (TRBO), and adverse events between the thin and thick groups. Technical success was defined as the feasibility of stent placement in the intended bile duct. Clinical success was defined as a successful procedure in which the level of total bilirubin was decreased to normal or ≥ 50% within 30 days. TRBO was defined as the period from stent placement to the occurrence of recurrent biliary obstruction [ 18 ]. Adverse events associated to the EUS-HGS were described in accordance with the American Society for Gastrointestinal Endoscopy dictionary within 1 month [ 19 ]. Statistical analysis The proportions of categorical variables were compared using Fisher’s exact test. The distributions of continuous variables pertaining to the baseline characteristics of the two treatment groups in the cohorts were compared using the Mann–Whitney U test. TRBO is evaluated using the Kaplan-Meier method and the log-rank test. A P value < 0.05 was considered statistically significant. Statistical analyses were performed using JMP 17.0 (SAS Institute Inc., Cary, North Carolina, USA). Results SEMS were placed through EUS-HGS in 84 patients; of these, 33 had SEMS placed without balloon fistula dilatation or a larger-diameter bougie catheter before the initial metal stent implantation in this study. Of the 33 patients, 13 and 20 were in the thin and thick groups, respectively (Figure 1). The characteristics of patients are presented in Table 1. The age, sex, etiology of biliary obstruction, or location of biliary strictures did not significantly differ between thin and thick groups. Outcomes of EUS-HGS Table 2 shows outcomes of EUS-HGS. There were significant differences in initial stenting success rates for SEMS placement between the two groups and was 100% (13/13) and 65.0% (13/20) in the thin and thick groups, respectively (p = 0.027). 6 of the 7 patients who failed initial stent placement had attempted stent placement in B3. The 7 cases in the thick group, where stent insertion was failure, were all successfully stented with 9 Fr mechanical or balloon fistula dilation in the end. The rate of technical success achieved increased to 100% in both groups. The rate of clinical success was 100% in the thin group and 95.0% in the thick group (p = 1.00). TRBO is shown in Figure 3. The median TRBO for the thin delivery stent group was 155 days (range, 2-199) and for the thick delivery stent group was 63 days (range, 9-241), not significantly different (hazard ratio, 0.56; 95% confidence interval, 0.20-1.59; p = 0.28). Biliary leakage was observed as an adverse event after EUS-HGS in 7.7% of patients in the thin group and 5.0% in the thick group; however, these values were not significantly different (p = 1.00). No case of other serious complications was observed. Discussion EUS-HGS is performed as a technique to biliary drainage. Despite its high technical and clinical success rates, there are limitations such as sure standard technique and safely devices which could appeal not only for patients but also for endoscopists. Advances in devices have lured endoscopists to the use of devices with thinner outer diameters. However, metal stents require adequate fistula dilation owing to the large external diameter of conventional thick stent delivery device depending on the case [ 15 ]. None of the thin delivery stents used in the present study required large fistula dilation with bougie, or balloon dilation. However, thick delivery stents require balloon fistula dilation or 9 Fr mechanical dilation. In this study, we compared the thin and thick delivery stents used for EUS-HGS to elucidate their efficacy for biliary drainage without the additional for balloon fistula or mechanical dilation. The thin delivery stents may be easier to use and may reduce the need for unnecessary fistula dilation. As a result, this stent would be promising patients underwent EUS-HGS. Most of the cases of failed initial stenting of thick delivery stents were in the B3 bile duct. This may be because the B3 bile duct has a large scope and stent insertion angle, making stent insertion more complicated. Previous studies have also reported that tight puncture angles require fistula dilation [ 20 ]. Balloon fistula dilation or large bougie fistula may be necessary in B3 if a thick delivery stent is to be implanted. Although TRBO was not significantly different in this study, the thin delivery stent had a better patency duration than the thick delivery stent. It is possible that even a narrow delivery stent can provide a patency period that is comparable to that of a conventional thick delivery stent [ 16 ]. Since study of TRBO of thin delivery stents has only been reported in a small number of cases, further study of a large number of cases is desirable. The complications associated with the use of thin and thick stents implanted using EUS-HGS were not significantly different. EUS-HGS can also be safely performed using thin delivery stents in this study. Regarding adverse events, in another study, peritonitis was observed in 3.3% of cases of EUS-BD performed using a thin delivery stent [ 17 ]. In EUS-HGS procedures, biliary leakage reportedly occurs because various devices must be replaced before stenting [ 21 ]. The dilatation step carries with it the risk of bile leaking into the abdominal cavity after dilatation [ 9 , 22 ]. The use of thin delivery stents may be advantageous in reducing unnecessary dilation procedures and avoid the peritonitis. Our study suffers from the limitation that it was a single facility retrospective study of a small group of patients. Therefore, prospective randomized controlled trials with many cases are required to validate our findings. In conclusion, thin delivery stents may facilitate stent placement without the need for balloon fistula dilation or large-diameter mechanical dilation. Thin-delivery stents may be a less invasive and safer approach to stent placement. Declarations Author contributions: All authors participated in this study. Tomoki Ogata was responsible for manuscript writing, drafting, conception, and design. Yusuke Kurita drafted, conceived, and designed the study; performed the endoscopic procedures; and assisted with manuscript writing. Shin Yagi, Takamitsu Sato, Sho Hasegawa, Kunihiro Hosono, Noritoshi Kobayashi, Itaru Endo, Kensuke Kubota, and Atsushi Nakajima performed the endoscopic procedures, analyzed the data, and provided clinical advice. All authors have approved the final draft of the manuscript. Funding Information: This research received no external funding. Institutional Review Board Statement This study was approved by the institutional review board of Yokohama City University Hospital (B200600003, approved on 1 May 2020). Informed Consent Statement Patient consent was waived because only medical information was used without invasion of the participants’ privacy in this retrospective observational study. Instead, all patients received an opt-out form for informed consent, and those who did not consent were excluded. Data Availability Statement Data are available on request because of restrictions, e.g., privacy or ethics. Acknowledgments The authors would like to thank all the patients, investigators, and the institutions involved in this study. Conflict of interests The authors declare no conflict of interest for this article. References Park DH, Jang JW, Lee SS, Seo DW, Lee SK, Kim MH. EUS-guided biliary drainage with transluminal stenting after failed ERCP: predictors of adverse events and long-term results. Gastrointest Endosc. 2011;74(6):1276–84. Vila JJ, Pérez-Miranda M, Vazquez-Sequeiros E, Abadia MA, Pérez-Millán A, González-Huix F, Gornals J, Iglesias-Garcia J, De la Serna C, Aparicio JR, et al. Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: a Spanish national survey. Gastrointest Endosc. 2012;76(6):1133–41. 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Maehara K, Hijioka S, Nagashio Y, Ohba A, Maruki Y, Suzuki H, Sone M, Okusaka T, Saito Y. Endoscopic ultrasound-guided hepaticogastrostomy or hepaticojejunostomy without dilation using a stent with a thinner delivery system. Endosc Int Open. 2020;8(8):E1034–8. Koga T, Hijioka S, Hisada Y, Maruki Y, Nagashio Y, Okusaka T, Saito Y. Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation using a novel fully covered metallic stent with a 5.9-Fr ultra-thin delivery system. Endoscopy. 2021;53(6):E223–5. Isayama H, Hamada T, Yasuda I, Itoi T, Ryozawa S, Nakai Y, Kogure H, Koike K. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc. 2015;27(2):259–64. Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr., Petersen BT, Petrini JL, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71(3):446–54. Ohno A, Fujimori N, Kaku T, Takamatsu Y, Matsumoto K, Murakami M, Teramatsu K, Takeno A, Hijioka M, Kawabe K, et al. Feasibility and Efficacy of Endoscopic Ultrasound-Guided Hepaticogastrostomy Without Dilation: A Propensity Score Matching Analysis. Dig Dis Sci. 2022;67(12):5676–84. Yamamoto Y, Ogura T, Nishioka N, Yamada T, Yamada M, Ueno S, Higuchi K. Risk factors for adverse events associated with bile leak during EUS-guided hepaticogastrostomy. Endosc Ultrasound. 2020;9(2):110–5. Park DH, Lee TH, Paik WH, Choi JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. Feasibility and safety of a novel dedicated device for one-step EUS-guided biliary drainage: A randomized trial. J Gastroenterol Hepatol. 2015;30(10):1461–6. Tables Table 1. Patient characteristics EUS-HGS: endoscopic ultrasound-guided hepaticogastrostomy Thin group n = 13 Thick group n = 20 p-value Age in years, median (range) 77 (45–91) 71.5 (36–83) 0.51 Sex, Male (%) 4 (30.8) 11 (55.0) 0.28 Primary disease (%) Pancreatic cancer Cholangiocarcinoma Other 6 (46.2) 4 (30.8) 3 (23.1) 7 (35.0) 9 (45.0) 4 (20.0) 0.72 0.49 1.00 Indications for EUS-HGS (%) Duodenal stenosis Insufficient papillary drainage Failed papillary cannulation Altered anatomy Other 5 (38.5) 2 (15.4) 4 (30.8) 1 (7.7) 1 (7.7) 5 (25.0) 6 (30.0) 3 (15.0) 1 (5.0) 5 (25.0) 0.46 0.43 0.39 1.00 0.36 Puncture site (%) B2 B3 4 (30.8) 9 (69.2) 5 (25.0) 15 (75.0) 1.00 Bile duct diameter (mm), median (range) 5 (3–9) 5.2 (4–11) 0.54 Fistula dilation device before initial stenting (%) Bougie dilator (7 Fr) 13 (100.0) 20 (100.0) 1.00 Stents (%) EGIS 6mm/10cm (6 Fr) HANAROSTENT Benefit 6mm/12cm (5.9 Fr) Niti-s S-type 6mm/12cm (8.5 Fr) Niti-s S-type 8mm/12cm (8.5 Fr) HANAROSTENT 6mm/12cm (8.5 Fr) 8 (61.6) 5 (38.5) - - - - - 17 (85.0) 2 (10.0) 1 (5.0) N/A Table 2. Outcomes of EUS-HGS Thin group n = 13 Thick group n = 20 p-value Initial stenting success 100％ (13/13) 65.0％ (13/20) 0.027 Additional fistula dilation (%) Bougie dilator (9 Fr) Balloon dilator (4 mm) 0 (0.0) 0 (0.0) 0 (0.0) 7 (35.0) 3 (15.0) 4 (20.0) 0.26 0.14 Successful stent placement after additional fistula dilation - 100% (7/7) N/A Treatment time, min, median (range) 30 (16–45) 30 (17–89) 0.45 Technical success 100% (13/13) 100% (20/20) 1.00 Clinical success 100% (13/13) 95.0% (19/20) 1.00 Adverse events Biliary peritonitis Bleeding Cholangitis 7.7% (1/13) 0% (0/13) 0% (0/13) 5.0% (1/20) 0% (0/20) 0% (0/20) 1.00 1.00 1.00 EUS-HGS: endoscopic ultrasound-guided hepaticogastrostomy Additional Declarations No competing interests reported. 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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-4016211","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":279166003,"identity":"71a06487-230d-4a75-a12c-a06de8987df6","order_by":0,"name":"Tomoki Ogata","email":"","orcid":"","institution":"Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Tomoki","middleName":"","lastName":"Ogata","suffix":""},{"id":279166004,"identity":"1caa5ccc-5d7a-49e6-84be-5ba60a424cc9","order_by":1,"name":"Yusuke 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University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Kunihiro","middleName":"","lastName":"Hosono","suffix":""},{"id":279166009,"identity":"2d98dc2f-02a9-4c4a-8b32-a909775c8f90","order_by":6,"name":"Noritoshi Kobayashi","email":"","orcid":"","institution":"Department of Oncology, Yokohama City University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Noritoshi","middleName":"","lastName":"Kobayashi","suffix":""},{"id":279166010,"identity":"edb61256-0482-49f5-b4d9-2058eb778600","order_by":7,"name":"Itaru Endo","email":"","orcid":"","institution":"Department of Gastroenterological Surgery, Yokohama City University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Itaru","middleName":"","lastName":"Endo","suffix":""},{"id":279166011,"identity":"94a08f9b-fd48-4ec0-b08b-29856a2c762d","order_by":8,"name":"Kensuke Kubota","email":"","orcid":"","institution":"Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Kensuke","middleName":"","lastName":"Kubota","suffix":""},{"id":279166012,"identity":"c8ac44e8-4fda-43a7-baf6-78f51ae650d7","order_by":9,"name":"Atsushi Nakajima","email":"","orcid":"","institution":"Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Atsushi","middleName":"","lastName":"Nakajima","suffix":""}],"badges":[],"createdAt":"2024-03-05 09:23:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4016211/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4016211/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":52694815,"identity":"e350beeb-d17b-4b9c-934a-f0e28eaf1fa8","added_by":"auto","created_at":"2024-03-14 15:44:23","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":26717,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart illustrating the patient selection and grouping criteria.\u003c/p\u003e","description":"","filename":"EUSHGSthindeliveryFigure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4016211/v1/984be9f72a1ca1ca52d960e2.png"},{"id":52694817,"identity":"24e424e6-3827-4bc2-afe8-9d44eb1f4465","added_by":"auto","created_at":"2024-03-14 15:44:23","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":214740,"visible":true,"origin":"","legend":"\u003cp\u003eIntroducing the stent used in this study.\u003c/p\u003e\n\u003cp\u003ea: HANAROSTENT Biliary Full Cover Benefit; Boston Scientific, Boston, USA (5.9 Fr)\u003c/p\u003e\n\u003cp\u003eb: EGIS Biliary Full Cover Stent; SB-KAWASUMI, Kanagawa, Japan (6 Fr)\u003c/p\u003e\n\u003cp\u003ec: Niti-S S-type biliary stent; Taewoong Medical, Seoul, Korea (8.5 Fr)\u003c/p\u003e\n\u003cp\u003ed: HANAROSTENT Biliary Full Cover; Boston Scientific, Boston, USA (8.5 Fr)\u003c/p\u003e","description":"","filename":"EUSHGSthindeliveryFigure2.png","url":"https://assets-eu.researchsquare.com/files/rs-4016211/v1/71108ca928b6c4dd029f2b6c.png"},{"id":52694814,"identity":"91060930-8c59-4e4f-99cb-c245b30fd484","added_by":"auto","created_at":"2024-03-14 15:44:23","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":51933,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier curves for TRBO with thin group and thick group.\u003c/p\u003e\n\u003cp\u003eTRBO: time to recurrent biliary obstruction\u003c/p\u003e","description":"","filename":"EUSHGSthindeliveryFigure3.png","url":"https://assets-eu.researchsquare.com/files/rs-4016211/v1/37faf720d1be6cf38e07865d.png"},{"id":52695418,"identity":"459a60ad-c6fc-4f7f-9216-d5605045dc47","added_by":"auto","created_at":"2024-03-14 15:52:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":608280,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4016211/v1/9e510195-4422-4f17-a24c-f2d62dfb4411.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Thin delivery stents can obviate the need for additional fistula dilatation of large diameter in endoscopic ultrasound-guided hepaticogastrostomy","fulltext":[{"header":"Introduction","content":"\u003cp\u003eRecently, endoscopic ultrasound-guided hepatogastrostomy (EUS-HGS) has been performed for biliary obstruction in cases of failed transpapillary drainage in recent years [\u003cspan additionalcitationids=\"CR2 CR3 CR4\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The safety of EUS-HGS has been previously reported. However, there are some adverse events could be taken place [\u003cspan additionalcitationids=\"CR7 CR8 CR9 CR10 CR11\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. EUS-HGS are composed of various steps for the success, fistula dilation is one of important technique, as some patients have difficulty with dilating the stomach wall or intrahepatic bile duct [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eNotably, conventional metal stents may require balloon fistula dilation or mechanical dilation of a large diameter in addition to mechanical dilation to implant an 8.5Fr self-expandable metal stent (SEMS) with such a thick delivery [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Despite the high technical success rates for EUS-HGS, few dedicated devices are available, and this technique has not yet been established as a standard practice.\u003c/p\u003e \u003cp\u003eThe use of thin delivery stents (5.9Fr or 6Fr) is expected to make it easier for the endoscopist to insert the stent [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Although there have been cases where the thick delivery stent required balloon fistula dilation or 9 Fr mechanical dilation, thin delivery stents may be inserted without the need for additional dilation. However, the need for balloon fistula or mechanical dilation of a large diameter before inserting in thin and thick diameter delivery stents has not been fully explored. Therefore, we compared the need for large fistula dilation using thin and thick delivery stents.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePatients\u003c/h2\u003e \u003cp\u003eThis is a retrospective cohort case study. The patients who underwent EUS-HGS were included Yokohama City University Hospital between April 2015 and January 2023. The inclusion criteria were: 1) patients who had a metal stent implanted at the time of EUS-HGS, and the exclusion criteria were 1) patients who had a plastic stent implanted and 2) patients who had balloon fistula dilatation, or larger diameter bougie catheter (\u0026thinsp;≧\u0026thinsp;9 Fr) before initial metal stenting (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). For comparison, patients were divided into thin delivery stent (thin group) and thick delivery stent (thick group) groups based on the stent delivery system at our institution, EUS-HGS is indicated when bile duct intubation is impossible or when reaching the duodenal papilla is not possible due to obstruction of the gastric or surgical anatomical changes outlet.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e The present study was approved by the institutional review board of Yokohama City University Hospital (B200600003, approved on 1 May 2020). Only medical information was used in this retrospective observational study, and participants privacy was not compromised. All patients provided informed consent and were included in the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eProcedures of EUS-HGS\u003c/h2\u003e \u003cp\u003eEUS-HGS was performed in all cases by experienced endoscopists specialized in EUS-guided procedures. The standard procedure of EUS-HGS used at our hospital is as follows: The endoscopic ultrasound (EU-ME2 or EU-ME1; Olympus, Tokyo, Japan, and GF-UCT260) was performed from the stomach to show the left intrahepatic bile duct (segment 2: B2 or segment 3: B3). A 19 G needle or a 22 G needle (Sono Tip Pro Control; Medi-Globe GmbH, Rosenheim, Germany; Expect; Boston Scientific, Boston, MA, USA; or, EZ shot 3 plus; Olympus, Tokyo, Japan) was used to puncture the left intrahepatic bile duct. After puncturing the intrahepatic bile duct, and aspirating bile juice, the bile duct was confirmed to be a bile duct by contrast. A guidewire (VisiGlide2 Olympus, Tokyo, Japan), or a Fielder 18 (Asahi Intec, Aichi, Japan) were inserted into the intrahepatic bile duct. Tract dilation from stomach to bile duct was conducted using a 7 Fr bougie dilation catheter (ES dilator; Zeon Medical Co., Ltd., Tokyo, Japan, or Soehendra Biliary Dilation Catheter; Cook Japan, Tokyo, Japan).\u003c/p\u003e \u003cp\u003eAfter the tract bougie dilation, SEMS was inserted, with a stent diameter of either 6 mm or 8 mm and a length of 10 cm or 12 cm. The thin delivery stents (thin group) were placed using a delivery device with a diameter of 5.9 Fr (HANAROSTENT Biliary Full Cover Benefit; Boston Scientific, Boston, USA) or 6 Fr (EGIS Biliary Full Cover Stent; SB-KAWASUMI, Kanagawa, Japan). Thick delivery stents (thick group) were placed using 8.5 Fr delivery stents (Niti-S S-type biliary stents; Taewoong Medical, Seoul, Korea, and HANAROSTENT Biliary Full Cover; Boston Scientific, Boston, USA) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eIn cases where SEMS insertion was unsuccessful after initial dilation using 7 Fr bougie dilation catheter, additional dilatation was performed using a balloon catheter (REN biliary dilation catheter; 4 mm) or a large diameter bougie catheter (Soehendra Biliary Dilation Catheter; 9 Fr in diameter).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eEndpoints\u003c/h2\u003e \u003cp\u003eThe primary endpoint was to compare the rate of initial stenting success between the thin and thick stent groups. Initial stenting success was defined as cases in which stenting was possible with 7 Fr mechanical fistula dilation alone, without balloon dilation of the fistula or a large diameter bougie catheter (\u0026lt;\u0026thinsp;9 Fr). In cases where initial stenting was unsuccessful, additional fistula dilation was conducted using a balloon catheter or a large mechanical catheter (9 Fr) depend on the situation. The secondary endpoints were the rate of technical success, the rate of clinical success, time to recurrent biliary obstruction (TRBO), and adverse events between the thin and thick groups. Technical success was defined as the feasibility of stent placement in the intended bile duct. Clinical success was defined as a successful procedure in which the level of total bilirubin was decreased to normal or \u0026ge;\u0026thinsp;50% within 30 days. TRBO was defined as the period from stent placement to the occurrence of recurrent biliary obstruction [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Adverse events associated to the EUS-HGS were described in accordance with the American Society for Gastrointestinal Endoscopy dictionary within 1 month [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe proportions of categorical variables were compared using Fisher\u0026rsquo;s exact test. The distributions of continuous variables pertaining to the baseline characteristics of the two treatment groups in the cohorts were compared using the Mann\u0026ndash;Whitney U test. TRBO is evaluated using the Kaplan-Meier method and the log-rank test. A P value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant. Statistical analyses were performed using JMP 17.0 (SAS Institute Inc., Cary, North Carolina, USA).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eSEMS were placed through EUS-HGS in 84 patients; of these, 33 had SEMS placed without balloon fistula dilatation or a larger-diameter bougie catheter before the initial metal stent implantation in this study. Of the 33 patients, 13 and 20 were in the thin and thick groups, respectively (Figure 1). The characteristics of patients are presented in Table 1. The age, sex, etiology of biliary obstruction, or location of biliary strictures did not significantly differ between thin and thick groups. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eOutcomes of EUS-HGS\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 2 shows outcomes of EUS-HGS. There were significant differences in\u0026nbsp;initial stenting success\u0026nbsp;rates for SEMS placement\u0026nbsp;between the two groups and was 100% (13/13) and 65.0% (13/20) in the thin and thick groups, respectively (p = 0.027).\u0026nbsp;6\u0026nbsp;of the 7 patients who failed initial stent placement had attempted stent placement in B3. The 7 cases in the thick group, where stent insertion was\u0026nbsp;failure, were all successfully stented with 9 Fr mechanical or balloon fistula dilation in the end. The rate of technical success achieved increased to 100% in both groups. The rate of clinical success was 100% in the thin group and 95.0% in the thick group (p = 1.00).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTRBO is shown in Figure 3.\u0026nbsp;The median TRBO for the thin delivery stent group was 155 days (range, 2-199) and for the thick delivery stent group was 63 days (range, 9-241), not significantly different\u0026nbsp;(hazard ratio, 0.56; 95% confidence interval, 0.20-1.59; p = 0.28).\u003c/p\u003e\n\u003cp\u003eBiliary leakage was observed as an adverse event after EUS-HGS in 7.7% of patients in the thin group and 5.0% in the thick group; however, these values were not significantly different (p = 1.00). No case of other serious complications was observed.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eEUS-HGS is performed as a technique to biliary drainage. Despite its high technical and clinical success rates, there are limitations such as sure standard technique and safely devices which could appeal not only for patients but also for endoscopists. Advances in devices have lured endoscopists to the use of devices with thinner outer diameters. However, metal stents require adequate fistula dilation owing to the large external diameter of conventional thick stent delivery device depending on the case [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. None of the thin delivery stents used in the present study required large fistula dilation with bougie, or balloon dilation. However, thick delivery stents require balloon fistula dilation or 9 Fr mechanical dilation. In this study, we compared the thin and thick delivery stents used for EUS-HGS to elucidate their efficacy for biliary drainage without the additional for balloon fistula or mechanical dilation. The thin delivery stents may be easier to use and may reduce the need for unnecessary fistula dilation. As a result, this stent would be promising patients underwent EUS-HGS.\u003c/p\u003e \u003cp\u003eMost of the cases of failed initial stenting of thick delivery stents were in the B3 bile duct. This may be because the B3 bile duct has a large scope and stent insertion angle, making stent insertion more complicated. Previous studies have also reported that tight puncture angles require fistula dilation [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Balloon fistula dilation or large bougie fistula may be necessary in B3 if a thick delivery stent is to be implanted.\u003c/p\u003e \u003cp\u003eAlthough TRBO was not significantly different in this study, the thin delivery stent had a better patency duration than the thick delivery stent. It is possible that even a narrow delivery stent can provide a patency period that is comparable to that of a conventional thick delivery stent [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Since study of TRBO of thin delivery stents has only been reported in a small number of cases, further study of a large number of cases is desirable.\u003c/p\u003e \u003cp\u003eThe complications associated with the use of thin and thick stents implanted using EUS-HGS were not significantly different. EUS-HGS can also be safely performed using thin delivery stents in this study. Regarding adverse events, in another study, peritonitis was observed in 3.3% of cases of EUS-BD performed using a thin delivery stent [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. In EUS-HGS procedures, biliary leakage reportedly occurs because various devices must be replaced before stenting [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. The dilatation step carries with it the risk of bile leaking into the abdominal cavity after dilatation [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. The use of thin delivery stents may be advantageous in reducing unnecessary dilation procedures and avoid the peritonitis.\u003c/p\u003e \u003cp\u003eOur study suffers from the limitation that it was a single facility retrospective study of a small group of patients. Therefore, prospective randomized controlled trials with many cases are required to validate our findings.\u003c/p\u003e \u003cp\u003eIn conclusion, thin delivery stents may facilitate stent placement without the need for balloon fistula dilation or large-diameter mechanical dilation. Thin-delivery stents may be a less invasive and safer approach to stent placement.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor contributions:\u0026nbsp;\u003c/strong\u003eAll authors participated in this study. Tomoki Ogata was responsible for manuscript writing, drafting, conception, and design. Yusuke Kurita drafted, conceived, and designed the study; performed the endoscopic procedures; and assisted with manuscript writing. Shin Yagi, Takamitsu Sato, Sho Hasegawa, Kunihiro Hosono, Noritoshi Kobayashi, Itaru Endo, Kensuke Kubota, and Atsushi Nakajima performed the endoscopic procedures, analyzed the data, and provided clinical advice. All authors have approved the final draft of the manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding Information:\u0026nbsp;\u003c/strong\u003eThis research received no external funding.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInstitutional Review Board Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the institutional review board of Yokohama City University Hospital (B200600003, approved on 1 May 2020).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed Consent Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatient consent was waived because only medical information was used without invasion of the participants\u0026rsquo; privacy in this retrospective observational study. Instead, all patients received an opt-out form for informed consent, and those who did not consent were excluded.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData are available on request because of restrictions, e.g., privacy or ethics.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank all the patients, investigators, and the institutions involved in this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interests\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflict of interest for this article.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003ePark DH, Jang JW, Lee SS, Seo DW, Lee SK, Kim MH. 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Endoscopic ultrasound-guided biliary drainage: a review. Clin J Gastroenterol. 2014;7(2):94\u0026ndash;102.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang K, Zhu J, Xing L, Wang Y, Jin Z, Li Z. Assessment of efficacy and safety of EUS-guided biliary drainage: a systematic review. Gastrointest Endosc. 2016;83(6):1218\u0026ndash;27.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCho JH, Park SW, Kim EJ, Park CH, Park DH, Lee KJ, Lee SS. Long-term outcomes and predictors of adverse events of EUS-guided hepatico-gastrostomy for malignant biliary obstruction: Multicenter, retrospective study. Surg Endosc. 2022;36(12):8950\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmano M, Ogura T, Onda S, Takagi W, Sano T, Okuda A, Miyano A, Masuda D, Higuchi K. Prospective clinical study of endoscopic ultrasound-guided biliary drainage using novel balloon catheter (with video). J Gastroenterol Hepatol. 2017;32(3):716\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHonjo M, Itoi T, Tsuchiya T, Tanaka R, Tonozuka R, Mukai S, Sofuni A, Nagakawa Y, Iwasaki H, Kanai T. Safety and efficacy of ultra-tapered mechanical dilator for EUS-guided hepaticogastrostomy and pancreatic duct drainage compared with electrocautery dilator (with video). Endosc Ultrasound. 2018;7(6):376\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYagi S, Kurita Y, Sato T, Hasegawa S, Hosono K, Kobayashi N, Endo I, Saigusa Y, Kubota K, Nakajima A. Utility of Fine-Gauge Balloon Catheter for EUS-Guided Hepaticogastrostomy. \u003cem\u003eJ Clin Med\u003c/em\u003e 2022, 11(19).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaehara K, Hijioka S, Nagashio Y, Ohba A, Maruki Y, Suzuki H, Sone M, Okusaka T, Saito Y. Endoscopic ultrasound-guided hepaticogastrostomy or hepaticojejunostomy without dilation using a stent with a thinner delivery system. Endosc Int Open. 2020;8(8):E1034\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKoga T, Hijioka S, Hisada Y, Maruki Y, Nagashio Y, Okusaka T, Saito Y. Endoscopic ultrasound-guided choledochoduodenostomy without fistula dilation using a novel fully covered metallic stent with a 5.9-Fr ultra-thin delivery system. Endoscopy. 2021;53(6):E223\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eIsayama H, Hamada T, Yasuda I, Itoi T, Ryozawa S, Nakai Y, Kogure H, Koike K. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc. 2015;27(2):259\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr., Petersen BT, Petrini JL, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71(3):446\u0026ndash;54.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOhno A, Fujimori N, Kaku T, Takamatsu Y, Matsumoto K, Murakami M, Teramatsu K, Takeno A, Hijioka M, Kawabe K, et al. Feasibility and Efficacy of Endoscopic Ultrasound-Guided Hepaticogastrostomy Without Dilation: A Propensity Score Matching Analysis. Dig Dis Sci. 2022;67(12):5676\u0026ndash;84.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYamamoto Y, Ogura T, Nishioka N, Yamada T, Yamada M, Ueno S, Higuchi K. Risk factors for adverse events associated with bile leak during EUS-guided hepaticogastrostomy. Endosc Ultrasound. 2020;9(2):110\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePark DH, Lee TH, Paik WH, Choi JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. Feasibility and safety of a novel dedicated device for one-step EUS-guided biliary drainage: A randomized trial. J Gastroenterol Hepatol. 2015;30(10):1461\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Patient characteristics\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEUS-HGS: endoscopic ultrasound-guided hepaticogastrostomy\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"608\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\"\u003e\n \u003cp\u003eThin group\u003c/p\u003e\n \u003cp\u003en = 13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\"\u003e\n \u003cp\u003eThick group\u003c/p\u003e\n \u003cp\u003en = 20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003eAge in years, median (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\"\u003e\n \u003cp\u003e77 (45\u0026ndash;91)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\"\u003e\n \u003cp\u003e71.5 (36\u0026ndash;83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\"\u003e\n \u003cp\u003e0.51\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003eSex, \u0026nbsp;Male (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\"\u003e\n \u003cp\u003e4 (30.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\"\u003e\n \u003cp\u003e11\u0026nbsp;(55.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\"\u003e\n \u003cp\u003e0.28\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003ePrimary disease (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;Pancreatic cancer\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;Cholangiocarcinoma\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;Other\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e6 (46.2)\u003c/p\u003e\n \u003cp\u003e4\u0026nbsp;(30.8)\u003c/p\u003e\n \u003cp\u003e3 (23.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7\u0026nbsp;(35.0)\u003c/p\u003e\n \u003cp\u003e9 (45.0)\u003c/p\u003e\n \u003cp\u003e4 (20.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.72\u003c/p\u003e\n \u003cp\u003e0.49\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003eIndications for EUS-HGS (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;Duodenal stenosis\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;Insufficient papillary drainage\u003c/p\u003e\n \u003cp\u003eFailed papillary cannulation\u003c/p\u003e\n \u003cp\u003eAltered anatomy\u003c/p\u003e\n \u003cp\u003eOther\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5 (38.5)\u003c/p\u003e\n \u003cp\u003e2\u0026nbsp;(15.4)\u003c/p\u003e\n \u003cp\u003e4 (30.8)\u003c/p\u003e\n \u003cp\u003e1 (7.7)\u003c/p\u003e\n \u003cp\u003e1 (7.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5\u0026nbsp;(25.0)\u003c/p\u003e\n \u003cp\u003e6\u0026nbsp;(30.0)\u003c/p\u003e\n \u003cp\u003e3 (15.0)\u003c/p\u003e\n \u003cp\u003e1 (5.0)\u003c/p\u003e\n \u003cp\u003e5\u0026nbsp;(25.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.46\u003c/p\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003cp\u003e0.39\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003cp\u003e0.36\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003ePuncture site (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;B2\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;B3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4\u0026nbsp;(30.8)\u003c/p\u003e\n \u003cp\u003e9 (69.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5\u0026nbsp;(25.0)\u003c/p\u003e\n \u003cp\u003e15\u0026nbsp;(75.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003eBile duct diameter (mm), median (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\"\u003e\n \u003cp\u003e5 (3\u0026ndash;9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\"\u003e\n \u003cp\u003e5.2 (4\u0026ndash;11)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\"\u003e\n \u003cp\u003e0.54\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003eFistula dilation device before initial stenting (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;Bougie dilator (7 Fr)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e13 (100.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e20 (100.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"51.23152709359606%\"\u003e\n \u003cp\u003eStents (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp;EGIS 6mm/10cm (6 Fr)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;HANAROSTENT Benefit 6mm/12cm (5.9 Fr)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;Niti-s S-type 6mm/12cm (8.5 Fr)\u003c/p\u003e\n \u003cp\u003eNiti-s S-type 8mm/12cm\u0026nbsp;(8.5 Fr)\u003c/p\u003e\n \u003cp\u003eHANAROSTENT\u0026nbsp;6mm/12cm\u0026nbsp;(8.5 Fr)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.24137931034483%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e8 (61.6)\u003c/p\u003e\n \u003cp\u003e5 (38.5)\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"17.077175697865353%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003cp\u003e17 (85.0)\u003c/p\u003e\n \u003cp\u003e2 (10.0)\u003c/p\u003e\n \u003cp\u003e1 (5.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"14.44991789819376%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2. Outcomes of EUS-HGS\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"590\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003eThin group\u003c/p\u003e\n \u003cp\u003en = 13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003eThick group\u003c/p\u003e\n \u003cp\u003en = 20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eInitial stenting success\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003e100％\u0026nbsp;(13/13)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003e65.0％\u0026nbsp;(13/20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\"\u003e\n \u003cp\u003e0.027\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eAdditional fistula dilation (%)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u0026nbsp;Bougie dilator (9 Fr)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u0026nbsp;Balloon dilator (4 mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0 (0.0)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003e7 (35.0)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;3 (15.0)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;4 (20.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e0.26\u003c/p\u003e\n \u003cp\u003e0.14\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eSuccessful stent placement after additional fistula dilation\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003e100% (7/7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\"\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eTreatment time, min, median (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003e30\u0026nbsp;(16\u0026ndash;45)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003e30 (17\u0026ndash;89)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\"\u003e\n \u003cp\u003e0.45\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eTechnical success\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003e100% (13/13)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003e100% (20/20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eClinical success\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\"\u003e\n \u003cp\u003e100% (13/13)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\"\u003e\n \u003cp\u003e95.0% (19/20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"38.37011884550085%\"\u003e\n \u003cp\u003eAdverse events\u003c/p\u003e\n \u003cp\u003eBiliary peritonitis\u003c/p\u003e\n \u003cp\u003eBleeding\u003c/p\u003e\n \u003cp\u003eCholangitis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.787775891341255%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7.7% (1/13)\u003c/p\u003e\n \u003cp\u003e0% (0/13)\u003c/p\u003e\n \u003cp\u003e0% (0/13)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.95755517826825%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5.0% (1/20)\u003c/p\u003e\n \u003cp\u003e0% (0/20)\u003c/p\u003e\n \u003cp\u003e0% (0/20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"11.884550084889643%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eEUS-HGS: endoscopic ultrasound-guided hepaticogastrostomy\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"biliary obstruction, endoscopic ultrasound, hepaticogastrostomy, thin delivery stents, fistula dilation","lastPublishedDoi":"10.21203/rs.3.rs-4016211/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4016211/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEndoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) often requires fistula dilation owing to the placement of large diameter of the delivery stent. The recently developed delivery devices as thin as 5.9/6.0 Fr may save the need for fistula dilation. Therefore, we investigated whether the large fistula dilation would be required or not in case of this newly developed thin diameter delivery stents.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe conducted a retrospective study involving 33 patients implemented with self-expandable metal stent (SEMS) during EUS-HGS. The patients were categorized based on the delivery device diameter into thin (n = 13; delivery device diameter: 5.9/6.0 Fr) and thick (n = 20; delivery device diameter: 8.5 Fr) groups. We compared the initial rate of success, technical success, and clinical success between the thin and thick groups. Initial rate of success was defined as successful stent placement without a balloon or large diameter mechanical dilation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe rate of initial stenting success was significantly higher in the thin group (100% [13/13]) compared with that in the thick group (65.0% [13/20]) (p = 0.027). In the thick group, seven cases with technical difficulty in stent placement could be successfully completed with additional fistula dilation with 9Fr bougie dilator, or 4mm balloon dilator; this resulted in a technical success of 100% in both groups ultimately. The rate of clinical success was 100% and 95.0% in the thin and thick groups, respectively (p = 1.00).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThin-delivery stents may facilitate stent placement without the need for a balloon fistula or large-diameter mechanical dilation.\u003c/p\u003e","manuscriptTitle":"Thin delivery stents can obviate the need for additional fistula dilatation of large diameter in endoscopic ultrasound-guided hepaticogastrostomy","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-14 15:44:18","doi":"10.21203/rs.3.rs-4016211/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-03-13T11:17:24+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-03-12T15:23:56+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-12T15:23:56+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Gastroenterology","date":"2024-03-05T09:20:42+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c5213cb7-ffdb-484c-9c8c-bdbae47f09f4","owner":[],"postedDate":"March 14th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2024-04-14T11:44:07+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-14 15:44:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4016211","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4016211","identity":"rs-4016211","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}