{"paper_id":"4795bfba-5591-4d96-a531-1ca1cb5a13e0","body_text":"Development of Novel Criteria for Drain Removal After Pancreaticogastrostomy in Pancreaticoduodenectomy: A Retrospective Analysis and Validation Study at a Single Institution | 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 Development of Novel Criteria for Drain Removal After Pancreaticogastrostomy in Pancreaticoduodenectomy: A Retrospective Analysis and Validation Study at a Single Institution Hisashi Murakami, Satoshi Okubo, Takuma Okada, Masaru Matsumura, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8325851/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Apr, 2026 Read the published version in Langenbeck's Archives of Surgery → Version 1 posted 9 You are reading this latest preprint version Abstract Purpose Postoperative pancreatic fistula (POPF) remains a major complication following pancreaticoduodenectomy (PD). Although pancreaticogastrostomy (PG) reduces POPF risk, the optimal criteria for drain management in PG cases remain unclear. Methods This single-institution retrospective study analyzed 195 consecutive PD cases involving a soft pancreas and PG. New criteria for safe drain removal were developed based on independent risk factors identified through a multivariate analysis. A prospective validation study was then conducted in 70 consecutive soft pancreas cases to assess the safety and efficacy of these criteria. Results In the retrospective cohort, white blood cell count (WBC) > 8200/µL, drain fluid amylase (DFA) > 160 U/L on postoperative day (POD) 5, and delayed nasogastric (NG) tube removal were identified as independent risk factors. The criteria for drain removal were defined as: WBC ≤ 8200/µL, DFA ≤ 160 U/L, and NG tube removal by POD5. In the validation cohort, 42 out of 70 patients met the criteria; none developed Clavien–Dindo grade IIIa or higher complications after drain removal. The incidence of delayed gastric emptying (DGE) was significantly lower ( p < 0.01). Conclusion In patients undergoing PG with a soft pancreas, application of the new criteria enables safe early drain removal and may help reduce the incidence of DGE. Gastric emptying Pancreaticoduodenectomy Pancreatic fistula Postoperative complications Drain removal Figures Figure 1 Figure 2 Introduction Pancreaticoduodenectomy (PD) is one of the most challenging surgical procedures in gastrointestinal surgery, with a complication rate of grade IIIa or higher according to the Clavien–Dindo classification[ 1 ] ranging between 15.5 and 24.2%, and a 90-day mortality rate of 1.8–3.0% [ 2 ]. Among these complications, postoperative pancreatic fistula (POPF) is the most significant because of its potential to prolong hospitalization, cause life-threatening postoperative bleeding, or necessitate reoperation. Even in high-volume centers, the incidence of POPF ranges from 3–45% [ 3 ] and soft pancreas is recognized as a significant risk factor [ 4 ]. To diagnose and manage POPF, surgical drains are routinely placed at the pancreatic anastomosis site. However, unnecessary prolonged drain placement increases the risk of retrograde infections; leading to intra-abdominal complications such as subsequent pancreatic fistulas. This highlights the need for proper drain management [ 5 ]. Although various criteria for drain removal have been proposed, most have focused on pancreatojejunostomy (PJ) rather than pancreaticogastrostomy (PG). While PG reportedly has a lower risk of POPF compared with PJ [ 6 ], the potential stress on the PG anastomosis caused by delayed gastric emptying (DGE) and postoperative dietary intake must be carefully considered. Additionally, various PG techniques including duct-to-mucosa anastomosis and invagination methods; may result in differing risks of pancreatic fistulas, potentially requiring unique criteria for drain removal. At our institution, we have employed an invagination method for PG. In this study, we retrospectively reviewed PD cases at our institution to identify the risk factors for prolonged drain placement in soft pancreatic cases. Based on these findings, we developed new criteria for drain removal specific to PG and validated their effectiveness in subsequent cases. Material and Methods Study design This was a single-institution, retrospective study. Study population Study 1 Between August 2011 and May 2022, consecutive patients who underwent PD with PG at our institution and had a soft pancreas were included. Two groups were compared: patients requiring drain placement for more than 3 weeks and those with drains removed within 3 weeks. Perioperative data were analyzed to identify the risk factors for prolonged drain placement. Based on these findings, a novel drain removal protocol was established. Study 2 (Validation) Consecutive patients who underwent PD between May 2023 and September 2025 were managed prospectively according to the newly established drain removal protocol, while data collection and analyses were performed retrospectively. Drains were removed on POD5 if the predefined criteria were met and the safety and risks of post-removal complications were assessed. Surgical procedure and postoperative management PD was primarily performed using the right approach [ 7 ], with the mesenteric approach adopted in cases suspected of superior mesenteric vein/artery invasion [ 8 ]. Regarding reconstruction, PG was routinely performed for all cases except those involving gastric resection, using the invagination method. Drains were placed at the PG and hepaticojejunostomy sites. The nasogastric (NG) tube was removed between POD2 and POD5, depending on the volume of drainage. Oral intake was initiated after NG tube removal with a liquid diet and was gradually advanced to a solid diet. The NG tube was removed when the drainage volume decreased to less than 500 mL/day. If vomiting occurred after NG tube was removed, reinsertion was performed. Cases where the NG tube remained in place on POD5 were defined as delayed NG tube removal. Jejunostomy tubes were not placed and enteral nutrition was not administered. Drains were routinely left in place until POD5 and were removed after meal initiation to ensure that the PG anastomosis tolerated gastric passage. The original criteria of drain removal were a drain fluid amylase (DFA) level less than three times the corresponding serum value and the absence of clinical signs of infection. In cases with POPF or intra-abdominal infection, the drains were maintained; and removal was deferred until inflammation was controlled and the drainage volume had decreased to less than 10 mL/day. In the validation cohort, the drain at the PG site was removed on POD5 in patients who met the updated removal criteria. Data collection Data such as age, sex, body mass index (BMI), history of diabetes, intraoperative findings, and postoperative laboratory data were extracted from electronic medical records. Complications were assessed by two independent surgeons. Pancreatic texture was retrospectively classified as soft when there was no evidence of pancreatic atrophy on CT scan and the main pancreatic duct diameter was ≤ 3 mm. Definition of complications Postoperative complications were assessed according to the Clavien–Dindo classification [ 1 ]. POPF was classified based on the International Study Group of Pancreatic Surgery (ISGPS) criteria [ 3 ]. Grade B requires prolonged drain placement or endoscopic/percutaneous intervention, while Grade C involves reoperation or organ failure. Clinically relevant (CR)-POPF included both Grades B and C. DGE was graded according to ISGPS guidelines [ 9 ]: Grade B required NG tube placement by POD7–14 or the inability to tolerate a solid diet by POD14. Grade C indicated the need for a NG tube beyond POD14 or the inability to tolerate a solid diet by POD21. Statistical analysis Continuous variables are presented as medians with interquartile ranges and were compared using the Mann–Whitney U test. Categorical variables are expressed as frequencies and percentages, and were analyzed using either the Pearson’s Chi-squared test or the Fisher’s exact test. Statistical significance was set at p < 0.05. In addition to the POPF risk factors reported in previous studies (sex, BMI, operative time, intraoperative blood loss, main pancreatic duct diameter, white blood cell [WBC] count, C-reactive protein [CRP], and DFA), items indicating stress on the PG anastomosis (NG tube drainage volume, delayed NG tube removal, and initiation of oral intake) were compared. Postoperative data up to POD5 were used because drain removal was always after solid meal initiation. Cases requiring drain placement for more than 3 weeks were compared with those in whom the drains were removed within 3 weeks. Receiver operating characteristic (ROC) curves were created to determine appropriate cut-off values for WBC count, CRP, and DFA. Variables with significant differences in the univariate analysis were further examined using multivariate analysis with logistic regression to identify independent risk factors. All analyses were conducted using R version 4.4.1 (The R Foundation for Statistical Computing, Vienna, Austria). Ethical compliance All procedures performed in studies involving human participants were conducted in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments. This study received approval from the Institutional Review Board of Toranomon Hospital (No.1919). Written informed consent was obtained from all patients. Results Study 1 Between August 2011 and May 2022, 195 consecutive patients with a soft pancreas who underwent PD were analyzed (Fig. 1 ). The median age of the patients was 68 (61, 74) years, and 127 patients (65%) were men. BMI was 22.6 (20.9, 24.8). The intraoperative blood loss was 685 (437, 1023) mL and the operative time was 263 (228–353) min. Drain removal was performed on POD 10 (8, 19), and the hospital discharge occurred on POD 25 (20, 35). Among the 195 cases included in the study, 42 (22%) had drains placed for more than 3 weeks. The breakdown of these cases was as follows: CR-POPF in 27 (13%), intra-abdominal infection in 11 (6%), bile leakage in 1 (0.5%), and unclear causes in 3 (2%) cases. Univariate analysis revealed significant associations between prolonged drain placement and sex (p < 0.01), BMI (p = 0.010), WBC on POD5 (p = 0.018), CRP on POD5 (p < 0.01), DFA on POD5 (p < 0.01), delayed NG tube removal (p = 0.024), operative time (p < 0.01), and intraoperative blood loss (p = 0.018) (Table 1). ROC curves were created, and the following cut-offs were determined: WBC > 8200/µL on POD5 (area under the curve [AUC]: 0.63), CRP > 6.4 mg/dL on POD5 (AUC: 0.69), and DFA > 158 U/L on POD5 (AUC: 0.74) (Fig. 2 ). Multivariate analysis identified the following as independent factors: male sex (p = 0.045, odds ratio [OR] 2.91, 95% confidence interval [CI] 1.02–8.29), WBC > 8200/µL on POD5 (p = 0.028, OR 2.60, 95% CI 1.10–6.11), DFA > 160 U/L on POD5 (p < 0.001, OR 4.90, 95% CI 2.16–11.08), and delayed NG tube removal (p = 0.050, OR 2.24, 95% CI 1.00–5.06) (Table 2). Based on the above results, the criteria for drain removal were established as follows: WBC < 8200/µL on POD5, DFA < 160 U/L on POD5, NG tube removal, and initiation of oral intake by POD5. Study 2 From May 2023 to September 2025, 70 consecutive cases of soft pancreas underwent PD with PG reconstruction. Among these 70 cases, the median age was 69 (60, 76) years, 43 patients (61%) were men, and the BMI was 22.4 (20.3, 24.6). Drain removal was performed 7 (6, 8) days postoperatively, and the hospital discharge days were 22 (17, 27) days post operation. A total of 42 cases (60%) met the criteria for drain removal. None of these patients required intervention after removal, and no complications of Clavien–Dindo grade IIIa or higher were observed. Conversely, among cases that did not meet the criteria, nine (32%) developed CR-POPF. The sensitivity and specificity of the removal criteria were 68.9% and 100%, respectively. When comparing the 195 cases before validation with the 70 cases after validation (Table 3), the median timing of drain removal was significantly reduced from 10 [8, 19] days to 7 (6, 8) days postoperatively (p < 0.001). The hospital discharge days were 25 (20, 35) days vs. 22 (17, 27) days postoperatively (p < 0.001), indicating a significant reduction in drain placement duration and the length of hospital stay. The rates of intra-abdominal infection were 18% vs. 28% (p = 0.10), CR-POPF were 13% vs. 13% (p = 1.0), and complications of Clavien–Dindo grade IIIa or higher were 24% vs. 30% (p = 0.38); respectively, with no significant differences. However, the incidence of DGE was significantly lower (39% vs. 13%, p < 0.01). Discussion PG has been reported to carry a lower risk of POPF compared with PJ [ 6 ]. Additionally, PG offers several advantages including fewer sutures, a simpler surgical technique, and the absence of major arterial stumps (e.g., gastroduodenal artery) near the anastomosis; which reduces the risk of pseudoaneurysm caused by POPF. However, because the pancreas is directly anastomosed to the stomach, there is a potential increased risk of developing DGE. Moreover, the rise in gastric pressure associated with the initiation of oral intake raises concerns regarding anastomotic leakage, making it challenging to apply the same drain removal criteria used for PJ. Several reports have examined drain management in patients undergoing PG and summarized the risk factors for POPF after PG (Table 4). Mintziras et al. [ 10 ] reported in a retrospective study of 188 patients undergoing PG that a DFA ≥ 303 U/L on POD1 and a CRP ≥ 20.3 mg/L on POD3 were risk factors for CR-POPF. Uemura et al. [ 11 ] in a retrospective study of 200 patients, identified non-serous drain output and a CRP ≥ 15.6 mg/L on POD4 as risk factors for CR-POPF. Yuan et al. [ 12 ] retrospectively analyzed 272 cases and reported that a DFA > 3000 U/L on POD1 was the cut-off value for predicting CR-POPF. However, these studies, including our own; differ substantially in surgical techniques, patient backgrounds, and postoperative management; which complicates the generalization of risk factors for CR-POPF following PG. Regarding reconstruction methods for PG, Mintziras et al. [ 10 ] similar to our approach, employed an invagination technique; however, they performed the anastomosis on the posterior gastric wall by opening the anterior gastric wall [ 13 ]. In contrast, our method utilizes only pancreatic sutures on the posterior gastric wall without opening the anterior gastric wall. Two other studies utilized duct-to-mucosa anastomosis for PG, indicating the lack of a standardized reconstruction method across institutions. The patient populations also varied, with the proportion of pancreatic cancer cases ranging between 18.8% and 50.5%. The frequency of soft pancreas, a known risk factor for POPF, also differs across studies. According to Czarnecka et al. [ 14 ] a soft pancreas not only increases the risk of POPF, but also leads to severe postoperative complications, raising concerns about whether the same drain management criteria used for hard pancreas cases should be applied. Notably, aside from our study, the other three did not account for pancreatic texture when analyzing POPF risk after PG; our exclusive focus on soft pancreas cases adds a novel dimension. With respect to postoperative management, three institutions including ours, initiated oral intake on POD5–7; however, the timing of drain removal relative to oral intake differed across institutions. At our facility, owing to cases in which increased stress on the PG anastomosis after oral intake led to anastomotic leakage and pancreatic fistulas, drain removal was performed only after oral intake. Consequently, we utilized POD5 data collected post-initiation of oral intake to evaluate independent risk factors for prolonged drain placement. Our analysis (Study 1) identified prolonged drain placement as being associated with a WBC > 8200/µL on POD5, a DFA > 160 U/L on POD5, and delayed NG tube removal. Increased gastric pressure resulting from DGE could place additional tension on the PG anastomosis, potentially causing POPF or intra-abdominal infections. Indicators such as WBC count and CRP levels are useful markers of intra-abdominal inflammation associated with POPF. In studies on PJ, El Naleeb et al. [ 15 ] reported that a WBC > 10,000/µL on both POD1 and POD5 was predictive of CR-POPF. While both Mintziras et al. [ 10 ] and Uemura et al. [ 11 ] identified CRP as an important inflammatory marker. In our study, the WBC count was significantly associated with prolonged drain placement, while a CRP > 6.4 mg/L was also notable (p = 0.068 in multivariate analysis). Procalcitonin has similarly been suggested as a potential predictor of POPF [ 16 ], with the selection of inflammatory markers largely based on institutional preferences. In summary, in Study 1 we established safer drain removal criteria by incorporating DFA to quantitatively evaluate POPF, WBC count as an indicator of intra-abdominal inflammation, and the timing of NG tube removal to assess DGE. In Study 2, among the 42 cases in which drains were removed according to the criteria, none developed intra-abdominal infections or POPF after removal, underscoring the significance of these safer criteria. Previous studies have suggested a DFA cut-off of 200 U/L on POD5 [ 17 ], and our cut-off of 160 U/L aligns with this proposal. The limitations of this study include its single center and retrospective design, and limited sample size. Selection bias may have occurred because clinical decisions sometimes delayed drain removal. Additionally, only 60% of soft pancreas cases met the criteria, resulting in unnecessary prolonged drainage in some cases. Future research should explore expanding these criteria or establishing new criteria for outliers through larger, multi-center studies. Conclusion In conclusion, for PG, if the WBC count on POD5 is ≤ 8200/µL, the DFA on POD5 is ≤ 160 U/L, and there is no DGE that hinders NG tube removal; the risk of complications is considered low, suggesting that the drain can be removed safely. The findings of this study may guide the development of standardized protocols for drain removal in patients undergoing PG, with the potential to reduce hospital stay durations and complications such as DGE, thereby improving postoperative outcomes and lowering healthcare costs. Declarations Conflict of Interest: The authors declare that they have no conflicts of interest. Ethics statement All procedures performed involving human participants were in accordance with the ethical standards of the institutional and national research committee, and with the 1964 Helsinki Declaration and its later amendments. This study received approval from the Institutional Review Board of Toranomon Hospital (No.1919). Consent to participate Informed consent was obtained from all individual participants included in the study. Funding: This research did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors. Author Contribution HM: study conception and conduction, data analysis and interpretation, and manuscript drafting; SO: data analysis and contribution to the manuscript; TO: data analysis and contributions to the manuscript; MM: data analysis and contributions to the manuscript; JS: data analysis and contribution to the manuscript; MH: manuscript revision and study supervision. All the authors have read and approved the manuscript. Acknowledgments None Data Availability The datasets used and analyzed in this study are available from the corresponding author upon reasonable request. 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Ann Surg 244:1–7 Salman MA, Elewa A, Elsherbiny M et al (2024) Postoperative pancreatic fistula after pancreaticogastrostomy versus pancreatojejunostomy after pancreatic resection, a comparative systematic review and meta-analysis. World J Surg 48:1467–1480 Nagakawa Y, Watanabe Y, Kozono S et al (2022) Surgical approaches to the superior mesenteric artery during minimally invasive pancreaticoduodenectomy: A systematic review. J Hepatobiliary Pancreat Sci 29:114–123 Nakao A (2016) The mesenteric approach in pancreatoduodenectomy. Dig Surg 33:308–313 Wente MN, Bassi C, Dervenis C et al (2007) Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS) Surgery 142:761–768 Mintziras I, Maurer E, Kanngiesser V et al (2020) C-reactive protein and drain amylase accurately predict clinically relevant pancreatic fistula after partial pancreaticoduodenectomy. Int J Surg 76:53–58 Uemura K, Murakami Y, Sudo T et al (2014) Indicators for proper management of surgical drains following pancreaticoduodenectomy. J Surg Oncol 109:702–707 Yuan S, Kim JH, Li GY et al (2022) The value of drain fluid amylase as a predictor of postoperative pancreatic fistula after pancreaticogastrostomy. ANZ J Surg 92:419–425 Bartsch DK, Langer P, Kanngießer V et al (2012) A simple and safe anastomosis for pancreatogastrostomy using one binding purse-string and two transfixing mattress sutures. Int J Surg Oncol 2012:718637 Czarnecka Z, Verhoeff K, Bigam D et al (2025) Impact of soft pancreas on pancreaticoduodenectomy outcomes and the development of the preoperative soft pancreas risk score. Ann Hepatobiliary Pancreat Surg 29:62–71 El Nakeeb A, Salah T, Sultan A et al (2013) Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg 37:1405–1418 Giardino A, Spolverato G, Regi P et al (2016) C-reactive protein and procalcitonin as predictors of postoperative inflammatory complications after pancreatic surgery. J Gastrointest Surg 20:1482–1492 Partelli S, Tamburrino D, Crippa S et al (2014) Evaluation of a predictive model for pancreatic fistula based on amylase value in drains after pancreatic resection. Am J Surg 208:634–639 Tables Table 1 to 4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.jpg Table 1. Comparison between long drainage group (n = 42) and control group (n = 153) Table2.jpg Table 2. Multivariate analysis identified male sex (p = 0.045, odds ratio [OR] 2.91, 95% confidence interval [CI] 1.02–8.29), white blood cell count >8200/μL on postoperative day (POD) 5 (p = 0.028, OR 2.60, 95% CI 1.10–6.11), drain fluid amylase >160 U/L on POD5 (p < 0.001, OR 4.90, 95% CI 2.16–11.08), and delayed nasogastric tube removal (p = 0.050, OR 2.24, 95% CI 1.00–5.06) as independent factors. Table3.jpg Table 3. Comparison between pre-validation (n = 195) and post-validation (n = 70) Table4.jpg Table 4. Summary of other reports regarding risk factors for postoperative pancreatic fistula in patients undergoing pancreaticogastrostomy NR, Not reported Cite Share Download PDF Status: Published Journal Publication published 01 Apr, 2026 Read the published version in Langenbeck's Archives of Surgery → Version 1 posted Editorial decision: Revision requested 26 Jan, 2026 Reviews received at journal 16 Jan, 2026 Reviews received at journal 06 Jan, 2026 Reviewers agreed at journal 04 Jan, 2026 Reviewers agreed at journal 03 Jan, 2026 Reviewers invited by journal 02 Jan, 2026 Editor assigned by journal 11 Dec, 2025 Submission checks completed at journal 10 Dec, 2025 First submitted to journal 10 Dec, 2025 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-8325851\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":false,\"archivedVersions\":[],\"articleType\":\"Research Article\",\"associatedPublications\":[],\"authors\":[{\"id\":569047465,\"identity\":\"504034a5-21cb-4e46-bc5f-17c043ec120a\",\"order_by\":0,\"name\":\"Hisashi 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06:19:42\",\"extension\":\"xml\",\"order_by\":13,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"acdc-reference\",\"size\":52829,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"e095dfa0b2c14a9cb467ca622835f6061structuring.xml\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/a24ceac0605338a2e4dcdf7e.xml\"},{\"id\":99790226,\"identity\":\"7623adf5-aff4-49df-b290-284d41f420bd\",\"added_by\":\"auto\",\"created_at\":\"2026-01-08 12:57:25\",\"extension\":\"html\",\"order_by\":14,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"acdc-reference\",\"size\":64351,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"earlyproof.html\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/96768151efeb06e749a36bb0.html\"},{\"id\":99790507,\"identity\":\"2257b3e4-fcd3-41d4-870b-0e90a1629f84\",\"added_by\":\"auto\",\"created_at\":\"2026-01-08 12:58:16\",\"extension\":\"jpg\",\"order_by\":1,\"title\":\"Figure 1\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":330967,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eStudy outline\\u003c/p\\u003e\\n\\u003cp\\u003eA total of 396 patients were intended for pancreaticoduodenectomy at out institution between August 2011 and May 2022. Of these, 195 patients with soft pancreases were deemed eligible for inclusion.\\u003c/p\\u003e\\n\\u003cp\\u003ePD, pancreaticoduodenectomy\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Figure1.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/c45182bf59636e0a0e900c00.jpg\"},{\"id\":99495718,\"identity\":\"dc3be8b6-a86a-446c-8d48-c54471a6eceb\",\"added_by\":\"auto\",\"created_at\":\"2026-01-05 06:19:41\",\"extension\":\"jpg\",\"order_by\":2,\"title\":\"Figure 2\",\"display\":\"\",\"copyAsset\":false,\"role\":\"figure\",\"size\":561895,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eReceiver operating characteristic (ROC) curves\\u003c/p\\u003e\\n\\u003cp\\u003eROC curves were created to determine the following cut-offs: white blood cell count \\u0026gt; 8200/μL on postoperative day (POD) 5 (area under the curve [AUC]: 0.63), C-reactive protein \\u0026gt; 6.4 mg/dL on POD5 (AUC: 0.69), and drain fluid amylase \\u0026gt; 158 U/L on POD5 (AUC: 0.74)\\u003c/p\\u003e\\n\\u003cp\\u003eWBC, white blood cell count; CRP, C-reactive protein; DFA, drain fluid amylase; POD, postoperative day; AUC, area under the curve\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Figure2.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/dbb4d395dcaf26f3846caa90.jpg\"},{\"id\":106343354,\"identity\":\"75b115a1-b5d8-459d-9218-6a94073a6bb2\",\"added_by\":\"auto\",\"created_at\":\"2026-04-07 16:02:55\",\"extension\":\"pdf\",\"order_by\":0,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"manuscript-pdf\",\"size\":1432762,\"visible\":true,\"origin\":\"\",\"legend\":\"\",\"description\":\"\",\"filename\":\"manuscript.pdf\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/9010e4f6-ea58-4c2e-9763-ae6973d62ca8.pdf\"},{\"id\":99790360,\"identity\":\"aea363a2-6b5b-4131-838a-8060cb6cbf06\",\"added_by\":\"auto\",\"created_at\":\"2026-01-08 12:57:56\",\"extension\":\"jpg\",\"order_by\":1,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":766437,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eTable 1. Comparison between long drainage group (n = 42) and control group (n = 153)\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Table1.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/007f1ac1102ecf80b54a8b52.jpg\"},{\"id\":99790402,\"identity\":\"8ababfb8-8b09-4bba-b48e-ac91ac321766\",\"added_by\":\"auto\",\"created_at\":\"2026-01-08 12:58:03\",\"extension\":\"jpg\",\"order_by\":2,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":376897,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eTable 2. Multivariate analysis identified male sex (p = 0.045, odds ratio [OR] 2.91, 95% confidence interval [CI] 1.02–8.29), white blood cell count \\u0026gt;8200/μL on postoperative day (POD) 5 (p = 0.028, OR 2.60, 95% CI 1.10–6.11), drain fluid amylase \\u0026gt;160 U/L on POD5 (p \\u0026lt; 0.001, OR 4.90, 95% CI 2.16–11.08), and delayed nasogastric tube removal (p = 0.050, OR 2.24, 95% CI 1.00–5.06) as independent factors.\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Table2.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/0d1680f062276d2ae00098ff.jpg\"},{\"id\":99495723,\"identity\":\"8cabe237-86a0-456f-a3a2-0b9acd590714\",\"added_by\":\"auto\",\"created_at\":\"2026-01-05 06:19:42\",\"extension\":\"jpg\",\"order_by\":3,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":456512,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eTable 3. Comparison between pre-validation (n = 195) and post-validation (n = 70)\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Table3.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/7b9db4417c435c8db1c4207c.jpg\"},{\"id\":99495720,\"identity\":\"3a1e4000-42b5-483c-a008-2c20e99a78d3\",\"added_by\":\"auto\",\"created_at\":\"2026-01-05 06:19:41\",\"extension\":\"jpg\",\"order_by\":4,\"title\":\"\",\"display\":\"\",\"copyAsset\":false,\"role\":\"supplement\",\"size\":246203,\"visible\":true,\"origin\":\"\",\"legend\":\"\\u003cp\\u003eTable 4. Summary of other reports regarding risk factors for postoperative pancreatic fistula in patients undergoing pancreaticogastrostomy\\u003c/p\\u003e\\n\\u003cp\\u003eNR, Not reported\\u003c/p\\u003e\",\"description\":\"\",\"filename\":\"Table4.jpg\",\"url\":\"https://assets-eu.researchsquare.com/files/rs-8325851/v1/a426d9d8dedf7f18b819e4bd.jpg\"}],\"financialInterests\":\"No competing interests reported.\",\"formattedTitle\":\"Development of Novel Criteria for Drain Removal After Pancreaticogastrostomy in Pancreaticoduodenectomy: A Retrospective Analysis and Validation Study at a Single Institution\",\"fulltext\":[{\"header\":\"Introduction\",\"content\":\"\\u003cp\\u003ePancreaticoduodenectomy (PD) is one of the most challenging surgical procedures in gastrointestinal surgery, with a complication rate of grade IIIa or higher according to the Clavien\\u0026ndash;Dindo classification[\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e] ranging between 15.5 and 24.2%, and a 90-day mortality rate of 1.8\\u0026ndash;3.0% [\\u003cspan citationid=\\\"CR2\\\" class=\\\"CitationRef\\\"\\u003e2\\u003c/span\\u003e]. Among these complications, postoperative pancreatic fistula (POPF) is the most significant because of its potential to prolong hospitalization, cause life-threatening postoperative bleeding, or necessitate reoperation. Even in high-volume centers, the incidence of POPF ranges from 3\\u0026ndash;45% [\\u003cspan citationid=\\\"CR3\\\" class=\\\"CitationRef\\\"\\u003e3\\u003c/span\\u003e] and soft pancreas is recognized as a significant risk factor [\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e]. To diagnose and manage POPF, surgical drains are routinely placed at the pancreatic anastomosis site. However, unnecessary prolonged drain placement increases the risk of retrograde infections; leading to intra-abdominal complications such as subsequent pancreatic fistulas. This highlights the need for proper drain management [\\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eAlthough various criteria for drain removal have been proposed, most have focused on pancreatojejunostomy (PJ) rather than pancreaticogastrostomy (PG). While PG reportedly has a lower risk of POPF compared with PJ [\\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e], the potential stress on the PG anastomosis caused by delayed gastric emptying (DGE) and postoperative dietary intake must be carefully considered. Additionally, various PG techniques including duct-to-mucosa anastomosis and invagination methods; may result in differing risks of pancreatic fistulas, potentially requiring unique criteria for drain removal.\\u003c/p\\u003e \\u003cp\\u003eAt our institution, we have employed an invagination method for PG. In this study, we retrospectively reviewed PD cases at our institution to identify the risk factors for prolonged drain placement in soft pancreatic cases. Based on these findings, we developed new criteria for drain removal specific to PG and validated their effectiveness in subsequent cases.\\u003c/p\\u003e\"},{\"header\":\"Material and Methods\",\"content\":\"\\u003cdiv id=\\\"Sec3\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy design\\u003c/h2\\u003e \\u003cp\\u003eThis was a single-institution, retrospective study.\\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eStudy population\\u003c/h3\\u003e\\n\\u003cdiv id=\\\"Sec5\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy 1\\u003c/h2\\u003e \\u003cp\\u003eBetween August 2011 and May 2022, consecutive patients who underwent PD with PG at our institution and had a soft pancreas were included. Two groups were compared: patients requiring drain placement for more than 3 weeks and those with drains removed within 3 weeks. Perioperative data were analyzed to identify the risk factors for prolonged drain placement. Based on these findings, a novel drain removal protocol was established.\\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eStudy 2 (Validation)\\u003c/h3\\u003e\\n\\u003cp\\u003eConsecutive patients who underwent PD between May 2023 and September 2025 were managed prospectively according to the newly established drain removal protocol, while data collection and analyses were performed retrospectively. Drains were removed on POD5 if the predefined criteria were met and the safety and risks of post-removal complications were assessed.\\u003c/p\\u003e\\n\\u003ch3\\u003eSurgical procedure and postoperative management\\u003c/h3\\u003e\\n\\u003cp\\u003ePD was primarily performed using the right approach [\\u003cspan citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e], with the mesenteric approach adopted in cases suspected of superior mesenteric vein/artery invasion [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e]. Regarding reconstruction, PG was routinely performed for all cases except those involving gastric resection, using the invagination method.\\u003c/p\\u003e \\u003cp\\u003eDrains were placed at the PG and hepaticojejunostomy sites. The nasogastric (NG) tube was removed between POD2 and POD5, depending on the volume of drainage. Oral intake was initiated after NG tube removal with a liquid diet and was gradually advanced to a solid diet. The NG tube was removed when the drainage volume decreased to less than 500 mL/day. If vomiting occurred after NG tube was removed, reinsertion was performed. Cases where the NG tube remained in place on POD5 were defined as delayed NG tube removal. Jejunostomy tubes were not placed and enteral nutrition was not administered.\\u003c/p\\u003e \\u003cp\\u003eDrains were routinely left in place until POD5 and were removed after meal initiation to ensure that the PG anastomosis tolerated gastric passage. The original criteria of drain removal were a drain fluid amylase (DFA) level less than three times the corresponding serum value and the absence of clinical signs of infection. In cases with POPF or intra-abdominal infection, the drains were maintained; and removal was deferred until inflammation was controlled and the drainage volume had decreased to less than 10 mL/day.\\u003c/p\\u003e \\u003cp\\u003eIn the validation cohort, the drain at the PG site was removed on POD5 in patients who met the updated removal criteria.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec8\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eData collection\\u003c/h2\\u003e \\u003cp\\u003eData such as age, sex, body mass index (BMI), history of diabetes, intraoperative findings, and postoperative laboratory data were extracted from electronic medical records. Complications were assessed by two independent surgeons. Pancreatic texture was retrospectively classified as soft when there was no evidence of pancreatic atrophy on CT scan and the main pancreatic duct diameter was \\u0026le;\\u0026thinsp;3 mm.\\u003c/p\\u003e \\u003c/div\\u003e\\n\\u003ch3\\u003eDefinition of complications\\u003c/h3\\u003e\\n\\u003cp\\u003ePostoperative complications were assessed according to the Clavien\\u0026ndash;Dindo classification [\\u003cspan citationid=\\\"CR1\\\" class=\\\"CitationRef\\\"\\u003e1\\u003c/span\\u003e]. POPF was classified based on the International Study Group of Pancreatic Surgery (ISGPS) criteria [\\u003cspan citationid=\\\"CR3\\\" class=\\\"CitationRef\\\"\\u003e3\\u003c/span\\u003e]. Grade B requires prolonged drain placement or endoscopic/percutaneous intervention, while Grade C involves reoperation or organ failure. Clinically relevant (CR)-POPF included both Grades B and C.\\u003c/p\\u003e \\u003cp\\u003eDGE was graded according to ISGPS guidelines [\\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e]: Grade B required NG tube placement by POD7\\u0026ndash;14 or the inability to tolerate a solid diet by POD14. Grade C indicated the need for a NG tube beyond POD14 or the inability to tolerate a solid diet by POD21.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec10\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStatistical analysis\\u003c/h2\\u003e \\u003cp\\u003eContinuous variables are presented as medians with interquartile ranges and were compared using the Mann\\u0026ndash;Whitney U test. Categorical variables are expressed as frequencies and percentages, and were analyzed using either the Pearson\\u0026rsquo;s Chi-squared test or the Fisher\\u0026rsquo;s exact test. Statistical significance was set at p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.05.\\u003c/p\\u003e \\u003cp\\u003eIn addition to the POPF risk factors reported in previous studies (sex, BMI, operative time, intraoperative blood loss, main pancreatic duct diameter, white blood cell [WBC] count, C-reactive protein [CRP], and DFA), items indicating stress on the PG anastomosis (NG tube drainage volume, delayed NG tube removal, and initiation of oral intake) were compared. Postoperative data up to POD5 were used because drain removal was always after solid meal initiation. Cases requiring drain placement for more than 3 weeks were compared with those in whom the drains were removed within 3 weeks. Receiver operating characteristic (ROC) curves were created to determine appropriate cut-off values for WBC count, CRP, and DFA. Variables with significant differences in the univariate analysis were further examined using multivariate analysis with logistic regression to identify independent risk factors. All analyses were conducted using R version 4.4.1 (The R Foundation for Statistical Computing, Vienna, Austria).\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec11\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eEthical compliance\\u003c/h2\\u003e \\u003cp\\u003e All procedures performed in studies involving human participants were conducted in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments. This study received approval from the Institutional Review Board of Toranomon Hospital (No.1919). Written informed consent was obtained from all patients.\\u003c/p\\u003e \\u003c/div\\u003e\"},{\"header\":\"Results\",\"content\":\"\\u003cdiv id=\\\"Sec13\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy 1\\u003c/h2\\u003e \\u003cp\\u003eBetween August 2011 and May 2022, 195 consecutive patients with a soft pancreas who underwent PD were analyzed (Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e). The median age of the patients was 68 (61, 74) years, and 127 patients (65%) were men. BMI was 22.6 (20.9, 24.8). The intraoperative blood loss was 685 (437, 1023) mL and the operative time was 263 (228\\u0026ndash;353) min. Drain removal was performed on POD 10 (8, 19), and the hospital discharge occurred on POD 25 (20, 35). Among the 195 cases included in the study, 42 (22%) had drains placed for more than 3 weeks. The breakdown of these cases was as follows: CR-POPF in 27 (13%), intra-abdominal infection in 11 (6%), bile leakage in 1 (0.5%), and unclear causes in 3 (2%) cases. Univariate analysis revealed significant associations between prolonged drain placement and sex (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.01), BMI (p\\u0026thinsp;=\\u0026thinsp;0.010), WBC on POD5 (p\\u0026thinsp;=\\u0026thinsp;0.018), CRP on POD5 (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.01), DFA on POD5 (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.01), delayed NG tube removal (p\\u0026thinsp;=\\u0026thinsp;0.024), operative time (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.01), and intraoperative blood loss (p\\u0026thinsp;=\\u0026thinsp;0.018) (Table\\u0026nbsp;1). ROC curves were created, and the following cut-offs were determined: WBC\\u0026thinsp;\\u0026gt;\\u0026thinsp;8200/\\u0026micro;L on POD5 (area under the curve [AUC]: 0.63), CRP\\u0026thinsp;\\u0026gt;\\u0026thinsp;6.4 mg/dL on POD5 (AUC: 0.69), and DFA\\u0026thinsp;\\u0026gt;\\u0026thinsp;158 U/L on POD5 (AUC: 0.74) (Fig.\\u0026nbsp;\\u003cspan refid=\\\"Fig2\\\" class=\\\"InternalRef\\\"\\u003e2\\u003c/span\\u003e). Multivariate analysis identified the following as independent factors: male sex (p\\u0026thinsp;=\\u0026thinsp;0.045, odds ratio [OR] 2.91, 95% confidence interval [CI] 1.02\\u0026ndash;8.29), WBC\\u0026thinsp;\\u0026gt;\\u0026thinsp;8200/\\u0026micro;L on POD5 (p\\u0026thinsp;=\\u0026thinsp;0.028, OR 2.60, 95% CI 1.10\\u0026ndash;6.11), DFA\\u0026thinsp;\\u0026gt;\\u0026thinsp;160 U/L on POD5 (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001, OR 4.90, 95% CI 2.16\\u0026ndash;11.08), and delayed NG tube removal (p\\u0026thinsp;=\\u0026thinsp;0.050, OR 2.24, 95% CI 1.00\\u0026ndash;5.06) (Table\\u0026nbsp;2).\\u003c/p\\u003e \\u003cp\\u003e \\u003c/p\\u003e \\u003cp\\u003eBased on the above results, the criteria for drain removal were established as follows: WBC\\u0026thinsp;\\u0026lt;\\u0026thinsp;8200/\\u0026micro;L on POD5, DFA\\u0026thinsp;\\u0026lt;\\u0026thinsp;160 U/L on POD5, NG tube removal, and initiation of oral intake by POD5.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec14\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy 2\\u003c/h2\\u003e \\u003cp\\u003eFrom May 2023 to September 2025, 70 consecutive cases of soft pancreas underwent PD with PG reconstruction.\\u003c/p\\u003e \\u003cp\\u003eAmong these 70 cases, the median age was 69 (60, 76) years, 43 patients (61%) were men, and the BMI was 22.4 (20.3, 24.6). Drain removal was performed 7 (6, 8) days postoperatively, and the hospital discharge days were 22 (17, 27) days post operation. A total of 42 cases (60%) met the criteria for drain removal. None of these patients required intervention after removal, and no complications of Clavien\\u0026ndash;Dindo grade IIIa or higher were observed. Conversely, among cases that did not meet the criteria, nine (32%) developed CR-POPF. The sensitivity and specificity of the removal criteria were 68.9% and 100%, respectively.\\u003c/p\\u003e \\u003cp\\u003eWhen comparing the 195 cases before validation with the 70 cases after validation (Table\\u0026nbsp;3), the median timing of drain removal was significantly reduced from 10 [8, 19] days to 7 (6, 8) days postoperatively (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001). The hospital discharge days were 25 (20, 35) days vs. 22 (17, 27) days postoperatively (p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.001), indicating a significant reduction in drain placement duration and the length of hospital stay. The rates of intra-abdominal infection were 18% vs. 28% (p\\u0026thinsp;=\\u0026thinsp;0.10), CR-POPF were 13% vs. 13% (p\\u0026thinsp;=\\u0026thinsp;1.0), and complications of Clavien\\u0026ndash;Dindo grade IIIa or higher were 24% vs. 30% (p\\u0026thinsp;=\\u0026thinsp;0.38); respectively, with no significant differences. However, the incidence of DGE was significantly lower (39% vs. 13%, p\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.01).\\u003c/p\\u003e \\u003c/div\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003ePG has been reported to carry a lower risk of POPF compared with PJ [\\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e]. Additionally, PG offers several advantages including fewer sutures, a simpler surgical technique, and the absence of major arterial stumps (e.g., gastroduodenal artery) near the anastomosis; which reduces the risk of pseudoaneurysm caused by POPF. However, because the pancreas is directly anastomosed to the stomach, there is a potential increased risk of developing DGE. Moreover, the rise in gastric pressure associated with the initiation of oral intake raises concerns regarding anastomotic leakage, making it challenging to apply the same drain removal criteria used for PJ.\\u003c/p\\u003e \\u003cp\\u003eSeveral reports have examined drain management in patients undergoing PG and summarized the risk factors for POPF after PG (Table\\u0026nbsp;4). Mintziras et al. [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e] reported in a retrospective study of 188 patients undergoing PG that a DFA\\u0026thinsp;\\u0026ge;\\u0026thinsp;303 U/L on POD1 and a CRP\\u0026thinsp;\\u0026ge;\\u0026thinsp;20.3 mg/L on POD3 were risk factors for CR-POPF. Uemura et al. [\\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e] in a retrospective study of 200 patients, identified non-serous drain output and a CRP\\u0026thinsp;\\u0026ge;\\u0026thinsp;15.6 mg/L on POD4 as risk factors for CR-POPF. Yuan et al. [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e] retrospectively analyzed 272 cases and reported that a DFA\\u0026thinsp;\\u0026gt;\\u0026thinsp;3000 U/L on POD1 was the cut-off value for predicting CR-POPF. However, these studies, including our own; differ substantially in surgical techniques, patient backgrounds, and postoperative management; which complicates the generalization of risk factors for CR-POPF following PG.\\u003c/p\\u003e \\u003cp\\u003eRegarding reconstruction methods for PG, Mintziras et al. [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e] similar to our approach, employed an invagination technique; however, they performed the anastomosis on the posterior gastric wall by opening the anterior gastric wall [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. In contrast, our method utilizes only pancreatic sutures on the posterior gastric wall without opening the anterior gastric wall. Two other studies utilized duct-to-mucosa anastomosis for PG, indicating the lack of a standardized reconstruction method across institutions.\\u003c/p\\u003e \\u003cp\\u003eThe patient populations also varied, with the proportion of pancreatic cancer cases ranging between 18.8% and 50.5%. The frequency of soft pancreas, a known risk factor for POPF, also differs across studies. According to Czarnecka et al. [\\u003cspan citationid=\\\"CR14\\\" class=\\\"CitationRef\\\"\\u003e14\\u003c/span\\u003e] a soft pancreas not only increases the risk of POPF, but also leads to severe postoperative complications, raising concerns about whether the same drain management criteria used for hard pancreas cases should be applied. Notably, aside from our study, the other three did not account for pancreatic texture when analyzing POPF risk after PG; our exclusive focus on soft pancreas cases adds a novel dimension.\\u003c/p\\u003e \\u003cp\\u003e With respect to postoperative management, three institutions including ours, initiated oral intake on POD5\\u0026ndash;7; however, the timing of drain removal relative to oral intake differed across institutions. At our facility, owing to cases in which increased stress on the PG anastomosis after oral intake led to anastomotic leakage and pancreatic fistulas, drain removal was performed only after oral intake. Consequently, we utilized POD5 data collected post-initiation of oral intake to evaluate independent risk factors for prolonged drain placement. Our analysis (Study 1) identified prolonged drain placement as being associated with a WBC\\u0026thinsp;\\u0026gt;\\u0026thinsp;8200/\\u0026micro;L on POD5, a DFA\\u0026thinsp;\\u0026gt;\\u0026thinsp;160 U/L on POD5, and delayed NG tube removal. Increased gastric pressure resulting from DGE could place additional tension on the PG anastomosis, potentially causing POPF or intra-abdominal infections.\\u003c/p\\u003e \\u003cp\\u003eIndicators such as WBC count and CRP levels are useful markers of intra-abdominal inflammation associated with POPF. In studies on PJ, El Naleeb et al. [\\u003cspan citationid=\\\"CR15\\\" class=\\\"CitationRef\\\"\\u003e15\\u003c/span\\u003e] reported that a WBC\\u0026thinsp;\\u0026gt;\\u0026thinsp;10,000/\\u0026micro;L on both POD1 and POD5 was predictive of CR-POPF. While both Mintziras et al. [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e] and Uemura et al. [\\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e] identified CRP as an important inflammatory marker. In our study, the WBC count was significantly associated with prolonged drain placement, while a CRP\\u0026thinsp;\\u0026gt;\\u0026thinsp;6.4 mg/L was also notable (p\\u0026thinsp;=\\u0026thinsp;0.068 in multivariate analysis). Procalcitonin has similarly been suggested as a potential predictor of POPF [\\u003cspan citationid=\\\"CR16\\\" class=\\\"CitationRef\\\"\\u003e16\\u003c/span\\u003e], with the selection of inflammatory markers largely based on institutional preferences.\\u003c/p\\u003e \\u003cp\\u003eIn summary, in Study 1 we established safer drain removal criteria by incorporating DFA to quantitatively evaluate POPF, WBC count as an indicator of intra-abdominal inflammation, and the timing of NG tube removal to assess DGE.\\u003c/p\\u003e \\u003cp\\u003eIn Study 2, among the 42 cases in which drains were removed according to the criteria, none developed intra-abdominal infections or POPF after removal, underscoring the significance of these safer criteria. Previous studies have suggested a DFA cut-off of 200 U/L on POD5 [\\u003cspan citationid=\\\"CR17\\\" class=\\\"CitationRef\\\"\\u003e17\\u003c/span\\u003e], and our cut-off of 160 U/L aligns with this proposal.\\u003c/p\\u003e \\u003cp\\u003eThe limitations of this study include its single center and retrospective design, and limited sample size. Selection bias may have occurred because clinical decisions sometimes delayed drain removal. Additionally, only 60% of soft pancreas cases met the criteria, resulting in unnecessary prolonged drainage in some cases. Future research should explore expanding these criteria or establishing new criteria for outliers through larger, multi-center studies.\\u003c/p\\u003e\"},{\"header\":\"Conclusion\",\"content\":\"\\u003cp\\u003eIn conclusion, for PG, if the WBC count on POD5 is \\u0026le;\\u0026thinsp;8200/\\u0026micro;L, the DFA on POD5 is \\u0026le;\\u0026thinsp;160 U/L, and there is no DGE that hinders NG tube removal; the risk of complications is considered low, suggesting that the drain can be removed safely. The findings of this study may guide the development of standardized protocols for drain removal in patients undergoing PG, with the potential to reduce hospital stay durations and complications such as DGE, thereby improving postoperative outcomes and lowering healthcare costs.\\u003c/p\\u003e\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003e \\u003ch2\\u003eConflict of Interest:\\u003c/h2\\u003e \\u003cp\\u003eThe authors declare that they have no conflicts of interest.\\u003c/p\\u003e \\u003cp\\u003e \\u003cstrong\\u003eEthics statement\\u003c/strong\\u003e \\u003cp\\u003e All procedures performed involving human participants were in accordance with the ethical standards of the institutional and national research committee, and with the 1964 Helsinki Declaration and its later amendments. This study received approval from the Institutional Review Board of Toranomon Hospital (No.1919).\\u003c/p\\u003e \\u003c/p\\u003e \\u003cp\\u003e \\u003cstrong\\u003eConsent to participate\\u003c/strong\\u003e \\u003cp\\u003e Informed consent was obtained from all individual participants included in the study.\\u003c/p\\u003e\\u003ch2\\u003eFunding:\\u003c/h2\\u003e \\u003cp\\u003eThis research did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors.\\u003c/p\\u003e\\u003ch2\\u003eAuthor Contribution\\u003c/h2\\u003e\\u003cp\\u003eHM: study conception and conduction, data analysis and interpretation, and manuscript drafting; SO: data analysis and contribution to the manuscript; TO: data analysis and contributions to the manuscript; MM: data analysis and contributions to the manuscript; JS: data analysis and contribution to the manuscript; MH: manuscript revision and study supervision. All the authors have read and approved the manuscript.\\u003c/p\\u003e\\u003ch2\\u003eAcknowledgments\\u003c/h2\\u003e \\u003cp\\u003eNone\\u003c/p\\u003e\\u003ch2\\u003eData Availability\\u003c/h2\\u003e\\u003cp\\u003eThe datasets used and analyzed in this study are available from the corresponding author upon reasonable request.\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\u003cli\\u003e\\u003cspan\\u003eDindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205\\u0026ndash;213\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eMarubashi S, Takahashi A, Kakeji Y et al (2021) Surgical outcomes in gastroenterological surgery in Japan: Report of the National Clinical Database 2011\\u0026ndash;2019. Ann Gastroenterol Surg 5:639\\u0026ndash;658\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eBassi C, Marchegiani G, Dervenis C et al (2017) The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11. Years After Surg 161:584\\u0026ndash;591\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eHu BY, Wan T, Zhang WZ et al (2016) Risk factors for postoperative pancreatic fistula: Analysis of 539 successive cases of pancreaticoduodenectomy. World J Gastroenterol 22:7797\\u0026ndash;7805\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eKawai M, Tani M, Terasawa H et al (2006) Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg 244:1\\u0026ndash;7\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eSalman MA, Elewa A, Elsherbiny M et al (2024) Postoperative pancreatic fistula after pancreaticogastrostomy versus pancreatojejunostomy after pancreatic resection, a comparative systematic review and meta-analysis. World J Surg 48:1467\\u0026ndash;1480\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eNagakawa Y, Watanabe Y, Kozono S et al (2022) Surgical approaches to the superior mesenteric artery during minimally invasive pancreaticoduodenectomy: A systematic review. J Hepatobiliary Pancreat Sci 29:114\\u0026ndash;123\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eNakao A (2016) The mesenteric approach in pancreatoduodenectomy. Dig Surg 33:308\\u0026ndash;313\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eWente MN, Bassi C, Dervenis C et al (2007) Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS) Surgery 142:761\\u0026ndash;768\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eMintziras I, Maurer E, Kanngiesser V et al (2020) C-reactive protein and drain amylase accurately predict clinically relevant pancreatic fistula after partial pancreaticoduodenectomy. Int J Surg 76:53\\u0026ndash;58\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eUemura K, Murakami Y, Sudo T et al (2014) Indicators for proper management of surgical drains following pancreaticoduodenectomy. J Surg Oncol 109:702\\u0026ndash;707\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eYuan S, Kim JH, Li GY et al (2022) The value of drain fluid amylase as a predictor of postoperative pancreatic fistula after pancreaticogastrostomy. ANZ J Surg 92:419\\u0026ndash;425\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eBartsch DK, Langer P, Kanngie\\u0026szlig;er V et al (2012) A simple and safe anastomosis for pancreatogastrostomy using one binding purse-string and two transfixing mattress sutures. Int J Surg Oncol 2012:718637\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eCzarnecka Z, Verhoeff K, Bigam D et al (2025) Impact of soft pancreas on pancreaticoduodenectomy outcomes and the development of the preoperative soft pancreas risk score. Ann Hepatobiliary Pancreat Surg 29:62\\u0026ndash;71\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eEl Nakeeb A, Salah T, Sultan A et al (2013) Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg 37:1405\\u0026ndash;1418\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003eGiardino A, Spolverato G, Regi P et al (2016) C-reactive protein and procalcitonin as predictors of postoperative inflammatory complications after pancreatic surgery. J Gastrointest Surg 20:1482\\u0026ndash;1492\\u003c/span\\u003e\\u003c/li\\u003e \\u003cli\\u003e\\u003cspan\\u003ePartelli S, Tamburrino D, Crippa S et al (2014) Evaluation of a predictive model for pancreatic fistula based on amylase value in drains after pancreatic resection. Am J Surg 208:634\\u0026ndash;639\\u003c/span\\u003e\\u003c/li\\u003e\\u003c/ol\\u003e\"},{\"header\":\"Tables\",\"content\":\"\\u003cp\\u003eTable 1 to 4 are available in the Supplementary Files section.\\u003c/p\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":false,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":true,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"langenbecks-archives-of-surgery\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"laos\",\"sideBox\":\"Learn more about [Langenbeck's Archives of Surgery](http://link.springer.com/journal/423)\",\"snPcode\":\"423\",\"submissionUrl\":\"https://submission.nature.com/new-submission/423/3\",\"title\":\"Langenbeck's Archives of Surgery\",\"twitterHandle\":\"\",\"acdcEnabled\":true,\"dfaEnabled\":true,\"editorialSystem\":\"em\",\"reportingPortfolio\":\"Springer Hybrid\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":false},\"keywords\":\"Gastric emptying, Pancreaticoduodenectomy, Pancreatic fistula, Postoperative complications, Drain removal\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-8325851/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-8325851/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003ch2\\u003ePurpose\\u003c/h2\\u003e \\u003cp\\u003ePostoperative pancreatic fistula (POPF) remains a major complication following pancreaticoduodenectomy (PD). Although pancreaticogastrostomy (PG) reduces POPF risk, the optimal criteria for drain management in PG cases remain unclear.\\u003c/p\\u003e\\u003ch2\\u003eMethods\\u003c/h2\\u003e \\u003cp\\u003eThis single-institution retrospective study analyzed 195 consecutive PD cases involving a soft pancreas and PG. New criteria for safe drain removal were developed based on independent risk factors identified through a multivariate analysis. A prospective validation study was then conducted in 70 consecutive soft pancreas cases to assess the safety and efficacy of these criteria.\\u003c/p\\u003e\\u003ch2\\u003eResults\\u003c/h2\\u003e \\u003cp\\u003eIn the retrospective cohort, white blood cell count (WBC)\\u0026thinsp;\\u0026gt;\\u0026thinsp;8200/\\u0026micro;L, drain fluid amylase (DFA)\\u0026thinsp;\\u0026gt;\\u0026thinsp;160 U/L on postoperative day (POD) 5, and delayed nasogastric (NG) tube removal were identified as independent risk factors. The criteria for drain removal were defined as: WBC\\u0026thinsp;\\u0026le;\\u0026thinsp;8200/\\u0026micro;L, DFA\\u0026thinsp;\\u0026le;\\u0026thinsp;160 U/L, and NG tube removal by POD5. In the validation cohort, 42 out of 70 patients met the criteria; none developed Clavien\\u0026ndash;Dindo grade IIIa or higher complications after drain removal. The incidence of delayed gastric emptying (DGE) was significantly lower (\\u003cem\\u003ep\\u003c/em\\u003e\\u0026thinsp;\\u0026lt;\\u0026thinsp;0.01).\\u003c/p\\u003e\\u003ch2\\u003eConclusion\\u003c/h2\\u003e \\u003cp\\u003eIn patients undergoing PG with a soft pancreas, application of the new criteria enables safe early drain removal and may help reduce the incidence of DGE.\\u003c/p\\u003e\",\"manuscriptTitle\":\"Development of Novel Criteria for Drain Removal After Pancreaticogastrostomy in Pancreaticoduodenectomy: A Retrospective Analysis and Validation Study at a Single Institution\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2026-01-05 06:19:33\",\"doi\":\"10.21203/rs.3.rs-8325851/v1\",\"editorialEvents\":[{\"type\":\"communityComments\",\"content\":0},{\"type\":\"decision\",\"content\":\"Revision requested\",\"date\":\"2026-01-26T09:54:59+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"editorInvitedReview\",\"content\":\"\",\"date\":\"2026-01-17T03:55:38+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"editorInvitedReview\",\"content\":\"\",\"date\":\"2026-01-07T03:12:33+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"reviewerAgreed\",\"content\":\"84984686796542073140309625450899759628\",\"date\":\"2026-01-04T14:44:47+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"reviewerAgreed\",\"content\":\"214019803256363914213174705858943737944\",\"date\":\"2026-01-04T00:21:11+00:00\",\"index\":\"hide\",\"fulltext\":\"\"},{\"type\":\"reviewersInvited\",\"content\":\"\",\"date\":\"2026-01-02T12:47:47+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"editorAssigned\",\"content\":\"\",\"date\":\"2025-12-11T06:09:51+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"checksComplete\",\"content\":\"\",\"date\":\"2025-12-11T04:06:54+00:00\",\"index\":\"\",\"fulltext\":\"\"},{\"type\":\"submitted\",\"content\":\"Langenbeck's Archives of Surgery\",\"date\":\"2025-12-10T09:37:25+00:00\",\"index\":\"\",\"fulltext\":\"\"}],\"status\":\"published\",\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"langenbecks-archives-of-surgery\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":false,\"externalIdentity\":\"laos\",\"sideBox\":\"Learn more about [Langenbeck's Archives of Surgery](http://link.springer.com/journal/423)\",\"snPcode\":\"423\",\"submissionUrl\":\"https://submission.nature.com/new-submission/423/3\",\"title\":\"Langenbeck's Archives of Surgery\",\"twitterHandle\":\"\",\"acdcEnabled\":true,\"dfaEnabled\":true,\"editorialSystem\":\"em\",\"reportingPortfolio\":\"Springer Hybrid\",\"inReviewEnabled\":true,\"inReviewRevisionsEnabled\":false}}],\"origin\":\"\",\"ownerIdentity\":\"a9f17137-4fcc-4254-b61c-fd5df62d8005\",\"owner\":[],\"postedDate\":\"January 5th, 2026\",\"published\":true,\"recentEditorialEvents\":[],\"rejectedJournal\":[],\"revision\":\"\",\"amendment\":\"\",\"status\":\"published-in-journal\",\"subjectAreas\":[],\"tags\":[],\"updatedAt\":\"2026-04-07T16:01:01+00:00\",\"versionOfRecord\":{\"articleIdentity\":\"rs-8325851\",\"link\":\"https://doi.org/10.1007/s00423-026-04040-3\",\"journal\":{\"identity\":\"langenbecks-archives-of-surgery\",\"isVorOnly\":false,\"title\":\"Langenbeck's Archives of Surgery\"},\"publishedOn\":\"2026-04-01 15:57:48\",\"publishedOnDateReadable\":\"April 1st, 2026\"},\"versionCreatedAt\":\"2026-01-05 06:19:33\",\"video\":\"\",\"vorDoi\":\"10.1007/s00423-026-04040-3\",\"vorDoiUrl\":\"https://doi.org/10.1007/s00423-026-04040-3\",\"workflowStages\":[]},\"version\":\"v1\",\"identity\":\"rs-8325851\",\"journalConfig\":\"researchsquare\"},\"__N_SSP\":true},\"page\":\"/article/[identity]/[[...version]]\",\"query\":{\"redirect\":\"/article/rs-8325851\",\"identity\":\"rs-8325851\",\"version\":[\"v1\"]},\"buildId\":\"XKTyCvWXoU3ODBz1xrDgd\",\"isFallback\":false,\"isExperimentalCompile\":false,\"dynamicIds\":[84888],\"gssp\":true,\"scriptLoader\":[]}","source_license":"CC-BY-4.0","license_restricted":false}