Stapled Transection with Seamguard and Postoperative Pancreatic Fistula After Distal Pancreatectomy: A 10-year single centre experience

Stapled Transection with Seamguard and Postoperative Pancreatic Fistula After Distal Pancreatectomy: A 10-year single centre experience | 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 Stapled Transection with Seamguard and Postoperative Pancreatic Fistula After Distal Pancreatectomy: A 10-year single centre experience Nazmus Sakib, Mayank Bhandari This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9159586/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction: Postoperative pancreatic fistula (POPF) remains the most significant complication following distal pancreatectomy. Various pancreatic stump reinforcement techniques have been described, but evidence on their efficacy is conflicting and heterogeneous. The consequent uncertainty therefore limits the development of standardised and patient-tailored management strategies in clinical practices. This retrospective observational study aims to assess the association between the use of bioabsorbable staple-line reinforcement and the development of clinically relevant POPF after distal pancreatectomy within a large Western Australian tertiary care centre. Method: This retrospective cohort study analysed patients undergoing distal pancreatectomy at Fiona Stanley Hospital (January 2015–March 2025), grouped by surgical technique at the surgeon’s discretion. The primary outcome was clinically relevant POPF as per the ISGPS definition. Multivariable logistic regression was conducted to evaluate the independent association between stump closure techniques (with particular focus on bioabsorbable staple-line reinforcement) and clinically relevant POPF, while controlling for patient-related risk factors including age, sex, body mass index, diabetes mellitus, smoking status, ASA score, and underlying pathology. Anatomic risk factors such as pancreatic texture, main pancreatic duct diameter, and stump thickness were not included in the model, as these were not routinely documented in medical records. Results: A total of 92 patients were analysed. The Seamguard reinforcement group (n = 74) had a lower incidence of Grade B POPF (23%) compared to those without reinforcement (n = 18; 50%). This protective association remained significant after adjusting for age, sex, BMI, diabetes, smoking status, and surgical approach (OR: 0.239; p = 0.022) and was unaffected by additional buttressing techniques (OR: 0.260; p = 0.024). Conclusion: This observational study suggests staple line reinforcement with Seamguard is associated with lower rates of clinically relevant POPF, and this association appears independent of additional buttressing techniques and patient related risk factors. Further investigation of this association in relation to pancreatic anatomic factors, including thickness, texture and main pancreatic duct size, is needed to develop a standardised patient-tailored approach to minimising POPF incidence. Pancreatectomy Surgical Stapling Pancreatic fistula Retrospective Study Surgical Mesh Figures Figure 1 Figure 2 Figure 3 Introduction With advancements in abdominal imaging techniques and their widespread adoption, the detection rate of distal pancreatic neoplasms has increased significantly 1 . Many of these lesions are malignant or have significant potential to become malignant. Distal pancreatectomy (DP) remains the curative treatment for non-metastatic neoplasms arising in the neck, body or tail of the pancreas 2 . Minimally invasive laparoscopic and robotic approaches, having demonstrated comparable oncologic outcomes to open distal pancreatectomies, have significantly expanded the scope of candidates. 3 As a result, surgical resection is now increasingly offered to a wider patient demographic including older individuals and those with significant comorbidities. 4 Postoperative pancreatic fistula (POPF), or pancreatic leak, is a common and serious complication after pancreatic surgery, with clinically significant cases (ISGPS grade B/C) occurring in approximately 20–30% of patients after DP. Locally, POPF may manifest as pancreatic fluid collections causing mass effect on the stomach, leading to delayed gastric emptying, increased intestinal permeability with bacterial translocation, infected intra-abdominal collections, or erosion of nearby vessels resulting in pseudoaneurysms and hemorrhage. Systemically, it can trigger systemic inflammatory response syndrome (SIRS), disseminated intravascular coagulation (DIC), sepsis, and multi-organ failure 6 . Although distal pancreatectomy has a higher overall POPF than pancreatoduodenectomy, the associated morbidity and mortality are generally more severe after pancreatoduodenectomy due to greater surgical complexity. Consequently, substantial research has long focused on optimising pancreatico-enteric reconstruction, but recent attention has shifted to improving distal pancreatic stump closure and reinforcement to reduce POPF rates in distal pancreatectomy 7 . The two most common stump closure methods are stapler transection, widely used in minimally invasive distal pancreatectomy and hand-suturing after cold or energy-based transection. Adjunctive techniques - such as staple-line reinforcement, autologous/synthetic patches, and surgical glues/sealants - are frequently combined, varying by institutional practice and surgeon preference. However, studies evaluating these approaches show no single method is superior, with evidence remaining heterogenous and inconclusive Within our institution, bioabsorbable staple-line reinforcement ( such as Seamguard) is now routinely considered as part of distal pancreatic stump closure. However, there is a lack of published data from major hepato-biliary centres in Australia, limiting understanding of local practices and outcomes. This study aims to assess the association between bioabsorbable staple-line reinforcement with Seamguard and the incidence of clinically significant POPF at a large tertiary centre in Western Australia, and to compare these outcomes with the existing literature on POPF following distal pancreatectomy. Methodology This observational cohort study was conducted at a tertiary referral hospital and considered consecutive patients who underwent distal pancreatectomy between January 2015 and March 2025. All such patients managed by the Upper Gastro-intestinal surgical unit during this study period were included. However, procedures were excluded if they were abandoned intra-operatively, did not involve pancreatic resection, or involved completion pancreatectomy procedure. Furthermore, patients followed up privately at a separate hospital or had incomplete data were also excluded. The exclusions were applied to maintain consistency in the dataset for accurate interpretation of surgical outcomes and complications. Data collection De-identified data were collected through a review of departmental surgical records for patients who underwent distal pancreatectomy during the study period. Patient characteristics including age, sex, BMI, ASA score, diabetes status, and smoking status were also recorded. Operative details included surgical approach, methods of pancreatic transection, and stump reinforcement techniques (e.g. synthetic or autologous patch application, staple line reinforcement, sealant/glue application) were also collected. The primary outcome was postoperative pancreatic fistula (POPF), defined as per the 2016 updated International Study Group on Pancreatic Surgery (ISGPS) criteria: Grade A (biochemical leak) Defined as drain amylase level greater than three times the upper limit of normal serum level on postoperative day 3. These were recorded but excluded from further analysis of clinically significant POPF. Grade B POPF requiring drain retention beyond 3 weeks postoperatively or necessitating radiologic or endoscopic intervention. Grade C POPF associated with reoperation, intensive care unit admission for organ dysfunction, or mortality. Statistical analysis: Due to the absence of grade C postoperative pancreatic fistula (POPF) and the limited clinical relevance of grade A biochemical leaks, only grade B POPF was used as the outcome variable. All statistical analyses were performed using IBM SPSS (v31). Univariate analyses were conducted using two-way tables and Fisher’s exact test (p < 0.05), suitable for categorical data and the small sample size (n = 92). These examined association between patient characteristics (age, gender, BMI, smoking status, diabetes) and clinically significant POPF (Grade B). Additional univariate analyses assessed associations between stump closure techniques (staple line reinforcement, patch reinforcement, sealant application, oversewing) and clinically significant POPF. Multivariable logistic regression was conducted to evaluate the association between staple line reinforcement and clinically significant POPF, adjusting for age, BMI, surgical approach, smoking status and diabetes. Additional multivariable logistic regression analyses explored association involving combination of stump management techniques, accounting for their non-mutual exclusivity. Results Cohort characteristics A total of 106 cases were identified from the Upper GI surgical planner record between January 2015 and March 2025. Twelve cases were excluded due to intra-operative abandonment of pancreatic resection following detection of metastatic disease, and two additional cases were not considered due to incomplete data. Thus, 92 distal pancreatectomies were included in the analysis. The cohort included 53 women (57.6%) and 39 men (42.4%) with a median age of 62 years (Table 1 ). Table 1 Overall Cohort Characteristics Description Value n = 92 Median age 62 Sex distribution Male (39) Female (53) Final Surgical approach Laparoscopic 48 Open 29 Robotic 15 Median BMI 27 ASA criteria I 7 II 50 III 35 Diabetes 21 Smokers 15 Operative factors Of the 92 procedures performed, 48 (52.2%) were laparoscopic, 29 (31.5%) were open, and 15 (16.3%) were robotic, as demonstrated in Table 2 . A total of 34 postoperative pancreatic fistulas (POPF) were observed (37.0%), including 8 Grade A biochemical leaks (8.7%) and 26 Grade B leaks (28.3%). No Grade C leaks occurred. Of the 26 Grade B leaks, 7 required endoscopic drain placement, 9 required CT-guided drain placement, and 10 had surgical drains remaining for more than 3 weeks. Among the clinically significant Grade B POPF cases, 12 (44%) developed infected intra-abdominal collections managed with targeted intravenous antibiotics. Patients with clinically significant POPF had a median hospital length of stay one day longer than those without, and the POPF-related readmission rate was 53.8%. Table 2 Histopathologic diagnosis Description Value Pancreatic Ductal Adenocarcinoma 24 Intraductal Papillary Mucinous Neoplasm 12 Mucinous Neoplasm 14 Pancreatic Neuroendocrine Tumour 17 Serous cystadenoma 5 Metastatic disease 5 Pseudocyst 4 Benign cysts including no mass 11 Pancreatic transection was performed using a stapler in all 92 patients. Of these, 74 (80.4%) received staple line reinforcement with Seamguard, 6 (6.5%) had additional stump suturing after stapling, 28 (30.4%) had patch reinforcement, and 28 (30.4%) had sealant application. Seamguard: Of the 18 stumps stapled without staple line reinforcement, 9(50%) developed Grade B POPF, compared with 17 (23%) of the 74 stumps with staple line reinforcement. Univariate analysis showed an odds ratio of 0.298 (95% CI: 0.102–0.870), with a Fisher’s exact test p-value of 0.026. Although the overall length of stay for patients who received staple line reinforcement was neither clinically nor statistically significantly different, the rate of clinically significant leaks was notably lower in the reinforced group. Specifically, only 9 patients (12.2%) in the Seamguard group required readmission for a leak, compared with 6 patients (33.3%) in the non-Seamguard group (p = 0.068, Fisher’s exact test). Oversuture: Hand suturing was performed on the remnant stump in 6 patients. Clinically significant postoperative pancreatic fistula (Grade B POPF) was observed in 4 of those 6 patients (66.7%), compared with 22 of the remaining 86 patients (25.6%). Univariate analysis showed an odds ratio of 5.818 (95% CI: 0.996–33.992), with a Fisher’s exact test p -value of 0.051. Patch reinforcement: Patch reinforcement was used in 15 patients (16.3%). Clinically significant Grade B POPF was observed in 5 of these 15 patients (33.3%), compared with 21 of the remaining 77 patients (27.3%). Univariate analysis showed an odds ratio of 1.33 (95% CI: 0.408–4.360), with a Fisher’s exact test p -value of Of the 15 patients, 3 were Autologous (falciform ligament), 2 where biomesh, and 10 were collagen-based (Hemopatch or Tachosil). The 5 observed Grade B POPF cases occurred in the collagen patch group. Sealant: Sealant was applied in 40 patients (43.5%). Clinically significant Grade B POPF was observed in 8 of these 40 patients (20%), compared with 18 of the remaining 52 patients (34.6%). Univariate analysis showed an odds ratio of 0.467 (95% CI: 0.180–1.237) with a p-value of 0.175 (Fisher’s exact test). Among the 40 patients receiving sealant, 12 received cyanoacrylate-based glue (1 leak observed), 27 received fibrin-based glue (7 leaks observed), and 1 received a gelatin-thrombin matrix-based glue (no leak observed). Confounders A multivariable logistic regression model was used to examine the association between staple line reinforcement and clinically significant Grade B POPF, adjusting for BMI, age, surgical approach, diabetes, and smoking status. Seamguard staple line reinforcement was associated with lower odds of Grade B POPF (OR = 0.239, 95% CI: 0.070–0.813, p = 0.022) (Table 3 ). Hand oversuturing however was associated with higher odds of Grade B POPF (OR: 8.576, 95% CI: 1.074–68.475, p = 0.043). The application of additional reinforcement techniques (sealants, patch reinforcement, or oversuturing) was not associated with significant changes in the observed relationship with staple line reinforcement (OR: 0.26 ; p = 0.024; 95% CI 0.08–0.840) (Table 4 ). Table 3 Multivariate Regression analysis of Staple Line Reinforcement technique Confounding factor Odds ratio 95% Confidence Intervals P value Age 0.991 0.959–1.024 0.582 BMI 1.023 0.940–1.113 0.604 Sex (Male) 1.077 0.376–3.090 0.890 Final Surgical Approach (Robotic) 0.518 0.127–2.604 0.472 Final Surgical Approach (Open) 1.964 0.656–5.884 0.228 Smoking 1.224 0.295–5.073 0.781 Diabetes 0.623 0.165–2.352 0.485 Staple Line Reinforcement 0.239 0.070–0.813 0.022 This analysis takes into consideration various pancreatic stump reinforcement techniques that may contribute towards clinically significant leaks - p values of Wald’s test is presented here Table 4 Multivariate Regression analysis of all pancreatic stump buttressing techniques Confounding factor Odds ratio 95% Confidence Intervals P value Staple Line Reinforcement 0.260 0.080–0.840 0.024 Patch enforcement 0.407 0.083–1.983 0.266 Hand suture 8.576 1.074–68.475 0.043 Sealant 0.421 0.083–1.983 0.105 This analysis takes into consideration various pancreatic stump reinforcement techniques that may contribute towards clinically significant leaks - p values of Wald’s test is presented here Discussion Postoperative pancreatic fistula (POPF) following distal pancreatectomy has been reported in up to 40% of cases 9 , with clinically significant leaks (Grade B) observed in approximately 20.2% and Grade C in 1.6%. in some series 5 . In this cohort, the overall POPF rate was approximately 37%, with 8.7% Grade A biochemical leaks and 28.3% Grade B leaks; no Grade C leaks were observed. The observed rate of Grade B POPF 34.5% in open procedures and 25.4% in minimally invasive approaches (laparoscopic and robotic) as shown in Fig. 1. Stapler-assisted pancreatic transection was used in all cases in this series. While this technique is commonly employed in minimally invasive distal pancreatectomy, randomized controlled trials and systematic reviews have not demonstrated a consistent difference in POPF rates compared with hand-sutured closure. For example, Kho et al. (2024) observed no significant difference in POPF rates between staple closure and suture closure in a small cohort of patients (n = 36) undergoing robotic distal pancreatectomy 13 . A larger meta-analysis by Zhou et al. (2010), comprising 16 articles (n = 2286), also found no significant difference in patients undergoing robotic DP; however, most centers are embracing the use of staple transection 14 . Staple line reinforcement with bioabsorbable material (Seamguard) has been evaluated in multiple meta-analysis and studies. Some reports, including Jensen et al. (2013), in a meta-analysis of 483 patients, Oweira et al. (2022), and Jimenez et al. (2007) have described lower POPF rates with reinforcement, while others such as Wennerblom et. al (2021) in a multicentre RCT (n = 106) found no significant difference between reinforced and non-reinforced staple transection (6). In this cohort, univariate analysis showed a lower observed rate of Grade B POPF with seamguard reinforcement (23% vs 50% without; OR 0.298, 95% CI 0.102–0.870, p = 0.026). The pattern persisted in multivariable logistic regression adjusting for age, sex, BMI, diabetes, smoking status, and surgical approach (OR 0.239, 95% CI 0.071–0.813, p = 0.022) as shown in Table 4 . Additional reinforcement techniques (patch reinforcement using autologous or synthetic materials or fibrin-based sealants) were used selectively. Published meta-analysis and trials have reported mixed findings. A 2024 meta-analysis by Chaouch et al., encompassing 9 studies (n = 740), observed that synthetic reinforcement patches (excluding fibrin-based types) were associated with lower incidence of POPF following distal pancreatectomy. However, no benefit was observed in terms of reoperation rates or length of hospital stay (16). On the other hand, fibrin-based sealants and combined patch-sealant approaches often showed no significant association (Mungroop et al. 2020; Bubis et al. 2021; Deng et al. in 2020). Conclusion This observational cohort study observed a lower incidence of clinically significant postoperative pancreatic fistula (Grade B POPF) in association with staple line reinforcement with bioabsorbable products such as SeamGuard during distal pancreatectomies. This pattern was present after adjustment for patients-related factors such as age, BMI, diabetes, and smoking status, as well as surgical approach. This observed association with seamguard remained consistent even when additional buttressing techniques (such as hand suturing, autologous or synthetic patch application or even fibrin based sealant application) were used concurrently. Further studies using larger sample sizes in prospective or randomised controlled designs, are required to explore the relationship between pancreatic stump management techniques and POPF rates. Such investigations should consider additional factors including stapler cartridge selection, intraoperative pancreatic texture assessment, mani pancreatic duct diameter, and radiographic pancreatic density measures to support more individualized approaches to stump closure. Limitations: A key limitation of this study is the relatively small cohort size (n = 92), which resulted in a limited number of clinically significant outcome events (Grade B POPF) and consequently reduced statistical power. This limited the ability to include a larger number of variables in a single multivariable model. To address this, two separate multivariate models were constructed; however, splitting the analysis may have reduced the overall robustness of the findings. As a retrospective study model, this investigation is also subject to selection bias. The choice of stump closure and reinforcement technique was influenced by intra-operative observations (such as pancreatic transection line thickness and tissue texture) which were not consistently available for inclusion in the analysis. Therefore, the observed associations between Seamguard reinforcement and lower rates of clinically significant POPF cannot establish causality. Prospective studies, ideally in the form of randomised controlled trials are required to further investigate these relationships. Such study should account for factors that may influence the selection of reinforcement techniques, including pancreatic neck thickness, pancreatic texture, main pancreatic duct diameter, and radiographic measures of pancreatic parenchymal quality. Declarations Disclosure statement: The authors of this paper declare no conflicts of interest. No financial support or potential for monetary gain was received in relation to this project. Ethical Approval: Prior to commencing data collection for this project, the authors obtained formal approval from the South Metropolitan Health Service Governance, Evidence, Knowledge, and Outcomes (GEKO) system. According to the National Statement on Ethical Conduct in Human Research, this project is classified as low to negligible risk. Upon completion of the report - the results and conclusion were reviewed by the General Surgical subcommittee of GEKO and approved for publication (Reference no. 56644). Author Contribution Nazmus Sakib conceptualised the research protocol, collected the data, oversaw the data analysis and the drafting of the manuscript.Mayank Bhandari conceptualised the research protocol, authorised and approved the data analysis and audited the manuscript. Data Availability The data underlying this study are not publicly available due to institutional governance and patient confidentiality requirements but may be made available from the corresponding author upon reasonable request and with appropriate institutional approvals. References 1. Harrington KA, Shukla-Dave A, Paudyal R, Do RKG. MRI of the Pancreas. Journal of Magnetic Resonance Imaging. 2020 Apr 17;53(2):347–59. 2. Kleeff J, Diener MK, Z’graggen K, Hinz U, Wagner M, Bachmann J, et al. Distal Pancreatectomy. Annals of Surgery. 2007 Apr;245(4):573–82. 3. Mohammed Abu Hilal, Maarten Korrel, Jones L, Jony van Hilst, Bergthor Björnsson, Boggi U, et al. Minimally Invasive versus Open Distal Pancreatectomy for Resectable Pancreatic Cancer (DIPLOMA): an International Randomised trial. Journal of Clinical Oncology. 2023 Jun 1;41(16_suppl):4163–3. 4. de Rooij T, van Hilst J, van Santvoort H, Boerma D, van den Boezem P, Daams F, et al. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD). Annals of Surgery. 2019 Jan;269(1):2–9. 5. Chong E, Ratnayake B, Lee S, French JJ, Wilson C, Roberts KJ, et al. Systematic review and meta-analysis of risk factors of postoperative pancreatic fistula after distal pancreatectomy in the era of 2016 International Study Group pancreatic fistula definition. HPB. 2021 Aug;23(8):1139–51. 6. Meierhofer C, Reinhold Fuegger, Biebl M, Rainer Schoefl. Pancreatic Fistulas: Current Evidence and Strategy—A Narrative Review. Journal of Clinical Medicine. 2023 Jul 31;12(15):5046–6. 7. McMillan MT, Christein JD, Callery MP, Behrman SW, Drebin JA, Hollis RH, et al. Comparing the burden of pancreatic fistulas after pancreatoduodenectomy and distal pancreatectomy. Surgery. 2016 Apr 1;159(4):1013–22. 8. Jensen EH, Portschy PR, Chowaniec J, Teng M. Meta-analysis of Bioabsorbable Staple Line Reinforcement and Risk of Fistula Following Pancreatic Resection. Journal of Gastrointestinal Surgery. 2013 Feb;17(2):267–72. 9. Erdem-Sanchez S, Müller PC, Kümmerli C, Hannoschöck A, Billeter AT, Müller BP. International Validation of the Distal Pancreatectomy Fistula Risk Score – More Than a Throw of the Dice? British Journal of Surgery [Internet]. 2025 May [cited 2025 Sep 18];112(Supplement_7). Available from: https://doi.org/10.1093/bjs/znaf092.043 10. Kho J, Hamady Z, Arshad A. HPB SO12 - Comparison of outcomes between stapled closure and sutured closure of pancreatic stump following robotic distal pancreatectomy. British journal of surgery [Internet]. 2024 Nov 1 [cited 2025 Sep 18];111(Supplement_9). Available from: https://doi.org/10.1093/bjs/znae271.245 11. Zhou W, Ran Lv, Wang X, Mou Y, Cai X, Herr I. Stapler vs suture closure of pancreatic remnant after distal pancreatectomy: a meta-analysis. The American Journal of Surgery. 2010 Jun 11;200(4):529–36. 12. Hani Oweira, Alessandro Mazotta, Mehrabi A, Christoph Reissfelder, Nuh Rahbari, Betzler A, et al. Using a Reinforced Stapler Decreases the Incidence of Postoperative Pancreatic Fistula After Distal Pancreatectomy: A Systematic Review and Meta-Analysis. World Journal of Surgery. 2022 May 7;46(8):1969–79. 13. Jimenez RE, Arun Mavanur, Macaulay WP. Staple Line Reinforcement Reduces Postoperative Pancreatic Stump Leak After Distal Pancreatectomy. Journal of Gastrointestinal Surgery. 2007 Feb 15;11(3):345–9. 14. J Wennerblom, Z Ateeb, C Jönsson, B Björnsson, B Tingstedt, C Williamsson, et al. Reinforced versus standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial. British journal of surgery [Internet]. 2021 Jan 1 [cited 2025 Sep 18];108(3):265–70. Available from: https://doi.org/10.1093/bjs/znaa113 15. Mohamed Ali Chaouch, Chadli Dziri, Selman Uranues, Fingerhut A. Pancreatic stump closure after distal pancreatectomy: Systematic review and meta-analysis of randomized clinical trials comparing non-autologous versus no reinforcement: Value of prediction intervals. The American journal of surgery. 2024 Mar 1;229:92–8. 16. Mungroop TH, Heijdeon N van der, Buschon OR, Hinghon IH de, Scheeperson JJ, Dijkgraafon MG, et al. Randomized clinical trial and meta-analysis of the impact of a fibrin sealant patch on pancreatic fistula after distal pancreatectomy: CPR trial. British Journal of Surgery. 2021 May;5(3). 17. Bubis LD, Ramy Behman, Roke R, Serrano PE, Khalil JA, Coburn NG, et al. PATCH-DP: a single-arm phase II trial of intra-operative application of HEMOPATCH™ to the pancreatic stump to prevent post-operative pancreatic fistula following distal pancreatectomy. HPB. 2021 Jun 9;24(1):72–8. 18. Deng Y, He S, Cheng Y, Cheng N, Gong J, Gong J, et al. Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery. Cochrane library. 2020 Mar 11;2020(3). Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-9159586","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":618365220,"identity":"ea577b6b-2fff-4931-8e8a-868518671f84","order_by":0,"name":"Nazmus Sakib","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABE0lEQVRIie3SMUsDMRTA8RcCV4QTB5dXhPoVUg7OFir9KjkOOhV0vEkphbiIXdNvUfALXDnwloBrwIJ3HIhjxKWj8XSTwLmJ5L89yI8HSQB8vj8YA7KoTIaDI7RTBXkXQpdDqUZRX9qJ806kJ44PRJZsdFdy1lsICgrJ/dNya5L9DliZ09c3AafMwce3W9FcZkjj3UOKnL8AUzwYrwUMNw7CdHITSYVBrOfMkgLinAdRqIA4yXMtTg4FhpG8eN+35LFqydS9hbQEGc6Dry2a0ybMIHESlXxeshV6Fo/4rAinuhZEZpiuXaQsa/uUV9crmTbaTIpBf5UWxrDJ+Z2D/CgEIML+BOx4/jtqfnfe5/P5/nkfqZFofeLVMBIAAAAASUVORK5CYII=","orcid":"","institution":"Fiona Stanley Hospital","correspondingAuthor":true,"prefix":"","firstName":"Nazmus","middleName":"","lastName":"Sakib","suffix":""},{"id":618365221,"identity":"b1171efc-7aa1-4539-903f-c246c71b4d0e","order_by":1,"name":"Mayank Bhandari","email":"","orcid":"","institution":"Fiona Stanley Hospital","correspondingAuthor":false,"prefix":"","firstName":"Mayank","middleName":"","lastName":"Bhandari","suffix":""}],"badges":[],"createdAt":"2026-03-18 12:53:32","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-9159586/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-9159586/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":106703270,"identity":"65e25f37-406a-420d-8608-bbc76ba5c5db","added_by":"auto","created_at":"2026-04-12 07:40:00","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":36737,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-9159586/v1/b8527c976b4a122668165daf.jpg"},{"id":106703268,"identity":"1fefbae7-99be-406a-961e-10501b7d6386","added_by":"auto","created_at":"2026-04-12 07:40:00","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":37648,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-9159586/v1/8b70580d1b3090fd01e87188.jpg"},{"id":106728134,"identity":"735085e8-8bd2-4e6a-83f8-ac0ecb969064","added_by":"auto","created_at":"2026-04-12 18:41:56","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":34601,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-9159586/v1/108486bd8e7e265ff67658ca.jpg"},{"id":108467472,"identity":"daed2d61-9fda-4a63-9ec3-d22d1594c35d","added_by":"auto","created_at":"2026-05-05 04:10:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":348704,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9159586/v1/1477e204-b670-4a56-8bc7-8e64e086ad9e.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Stapled Transection with Seamguard and Postoperative Pancreatic Fistula After Distal Pancreatectomy: A 10-year single centre experience","fulltext":[{"header":"Introduction","content":"\u003cp\u003eWith advancements in abdominal imaging techniques and their widespread adoption, the detection rate of distal pancreatic neoplasms has increased significantly \u003csup\u003e1\u003c/sup\u003e. Many of these lesions are malignant or have significant potential to become malignant. Distal pancreatectomy (DP) remains the curative treatment for non-metastatic neoplasms arising in the neck, body or tail of the pancreas \u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eMinimally invasive laparoscopic and robotic approaches, having demonstrated comparable oncologic outcomes to open distal pancreatectomies, have significantly expanded the scope of candidates.\u003csup\u003e3\u003c/sup\u003e As a result, surgical resection is now increasingly offered to a wider patient demographic including older individuals and those with significant comorbidities.\u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e \u003cp\u003ePostoperative pancreatic fistula (POPF), or pancreatic leak, is a common and serious complication after pancreatic surgery, with clinically significant cases (ISGPS grade B/C) occurring in approximately 20\u0026ndash;30% of patients after DP. Locally, POPF may manifest as pancreatic fluid collections causing mass effect on the stomach, leading to delayed gastric emptying, increased intestinal permeability with bacterial translocation, infected intra-abdominal collections, or erosion of nearby vessels resulting in pseudoaneurysms and hemorrhage. Systemically, it can trigger systemic inflammatory response syndrome (SIRS), disseminated intravascular coagulation (DIC), sepsis, and multi-organ failure \u003csup\u003e6\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAlthough distal pancreatectomy has a higher overall POPF than pancreatoduodenectomy, the associated morbidity and mortality are generally more severe after pancreatoduodenectomy due to greater surgical complexity. Consequently, substantial research has long focused on optimising pancreatico-enteric reconstruction, but recent attention has shifted to improving distal pancreatic stump closure and reinforcement to reduce POPF rates in distal pancreatectomy \u003csup\u003e7\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe two most common stump closure methods are stapler transection, widely used in minimally invasive distal pancreatectomy and hand-suturing after cold or energy-based transection. Adjunctive techniques - such as staple-line reinforcement, autologous/synthetic patches, and surgical glues/sealants - are frequently combined, varying by institutional practice and surgeon preference. However, studies evaluating these approaches show no single method is superior, with evidence remaining heterogenous and inconclusive\u003c/p\u003e \u003cp\u003eWithin our institution, bioabsorbable staple-line reinforcement ( such as Seamguard) is now routinely considered as part of distal pancreatic stump closure. However, there is a lack of published data from major hepato-biliary centres in Australia, limiting understanding of local practices and outcomes.\u003c/p\u003e \u003cp\u003eThis study aims to assess the association between bioabsorbable staple-line reinforcement with Seamguard and the incidence of clinically significant POPF at a large tertiary centre in Western Australia, and to compare these outcomes with the existing literature on POPF following distal pancreatectomy.\u003c/p\u003e"},{"header":"Methodology","content":"\u003cp\u003eThis observational cohort study was conducted at a tertiary referral hospital and considered consecutive patients who underwent distal pancreatectomy between January 2015 and March 2025. All such patients managed by the Upper Gastro-intestinal surgical unit during this study period were included. However, procedures were excluded if they were abandoned intra-operatively, did not involve pancreatic resection, or involved completion pancreatectomy procedure. Furthermore, patients followed up privately at a separate hospital or had incomplete data were also excluded. The exclusions were applied to maintain consistency in the dataset for accurate interpretation of surgical outcomes and complications.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eDe-identified data were collected through a review of departmental surgical records for patients who underwent distal pancreatectomy during the study period. Patient characteristics including age, sex, BMI, ASA score, diabetes status, and smoking status were also recorded. Operative details included surgical approach, methods of pancreatic transection, and stump reinforcement techniques (e.g. synthetic or autologous patch application, staple line reinforcement, sealant/glue application) were also collected.\u003c/p\u003e \u003cp\u003eThe primary outcome was postoperative pancreatic fistula (POPF), defined as per the 2016 updated International Study Group on Pancreatic Surgery (ISGPS) criteria:\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eGrade A (biochemical leak)\u003c/strong\u003e \u003cp\u003eDefined as drain amylase level greater than three times the upper limit of normal serum level on postoperative day 3. These were recorded but excluded from further analysis of clinically significant POPF.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eGrade B\u003c/strong\u003e \u003cp\u003ePOPF requiring drain retention beyond 3 weeks postoperatively or necessitating radiologic or endoscopic intervention.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eGrade C\u003c/strong\u003e \u003cp\u003ePOPF associated with reoperation, intensive care unit admission for organ dysfunction, or mortality.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis:\u003c/h2\u003e \u003cp\u003eDue to the absence of grade C postoperative pancreatic fistula (POPF) and the limited clinical relevance of grade A biochemical leaks, only grade B POPF was used as the outcome variable. All statistical analyses were performed using IBM SPSS (v31). Univariate analyses were conducted using two-way tables and Fisher\u0026rsquo;s exact test (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05), suitable for categorical data and the small sample size (n\u0026thinsp;=\u0026thinsp;92). These examined association between patient characteristics (age, gender, BMI, smoking status, diabetes) and clinically significant POPF (Grade B). Additional univariate analyses assessed associations between stump closure techniques (staple line reinforcement, patch reinforcement, sealant application, oversewing) and clinically significant POPF. Multivariable logistic regression was conducted to evaluate the association between staple line reinforcement and clinically significant POPF, adjusting for age, BMI, surgical approach, smoking status and diabetes. Additional multivariable logistic regression analyses explored association involving combination of stump management techniques, accounting for their non-mutual exclusivity.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eCohort characteristics\u003c/h2\u003e \u003cp\u003eA total of 106 cases were identified from the Upper GI surgical planner record between January 2015 and March 2025. Twelve cases were excluded due to intra-operative abandonment of pancreatic resection following detection of metastatic disease, and two additional cases were not considered due to incomplete data. Thus, 92 distal pancreatectomies were included in the analysis. The cohort included 53 women (57.6%) and 39 men (42.4%) with a median age of 62 years (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOverall Cohort Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDescription\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eValue\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;92\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMedian age\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e62\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSex distribution\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eMale (39)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eFemale (53)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFinal Surgical approach\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eLaparoscopic\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e48\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eOpen\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e29\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eRobotic\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e15\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedian BMI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e27\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eASA criteria\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eI\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e7\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eII\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e50\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eIII\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e35\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e21\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSmokers\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e15\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOperative factors\u003c/h3\u003e\n\u003cp\u003eOf the 92 procedures performed, 48 (52.2%) were laparoscopic, 29 (31.5%) were open, and 15 (16.3%) were robotic, as demonstrated in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. A total of 34 postoperative pancreatic fistulas (POPF) were observed (37.0%), including 8 Grade A biochemical leaks (8.7%) and 26 Grade B leaks (28.3%). No Grade C leaks occurred. Of the 26 Grade B leaks, 7 required endoscopic drain placement, 9 required CT-guided drain placement, and 10 had surgical drains remaining for more than 3 weeks. Among the clinically significant Grade B POPF cases, 12 (44%) developed infected intra-abdominal collections managed with targeted intravenous antibiotics. Patients with clinically significant POPF had a median hospital length of stay one day longer than those without, and the POPF-related readmission rate was 53.8%.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eHistopathologic diagnosis\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDescription\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eValue\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePancreatic Ductal Adenocarcinoma\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntraductal Papillary Mucinous Neoplasm\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMucinous Neoplasm\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e14\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePancreatic Neuroendocrine Tumour\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e17\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSerous cystadenoma\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e5\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMetastatic disease\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e5\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePseudocyst\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e4\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBenign cysts including no mass\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e11\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003ePancreatic transection was performed using a stapler in all 92 patients. Of these, 74 (80.4%) received staple line reinforcement with Seamguard, 6 (6.5%) had additional stump suturing after stapling, 28 (30.4%) had patch reinforcement, and 28 (30.4%) had sealant application.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eSeamguard:\u003c/h2\u003e \u003cp\u003eOf the 18 stumps stapled without staple line reinforcement, 9(50%) developed Grade B POPF, compared with 17 (23%) of the 74 stumps with staple line reinforcement. Univariate analysis showed an odds ratio of 0.298 (95% CI: 0.102\u0026ndash;0.870), with a Fisher\u0026rsquo;s exact test p-value of 0.026. Although the overall length of stay for patients who received staple line reinforcement was neither clinically nor statistically significantly different, the rate of clinically significant leaks was notably lower in the reinforced group. Specifically, only 9 patients (12.2%) in the Seamguard group required readmission for a leak, compared with 6 patients (33.3%) in the non-Seamguard group (p\u0026thinsp;=\u0026thinsp;0.068, Fisher\u0026rsquo;s exact test).\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOversuture:\u003c/h3\u003e\n\u003cp\u003eHand suturing was performed on the remnant stump in 6 patients. Clinically significant postoperative pancreatic fistula (Grade B POPF) was observed in 4 of those 6 patients (66.7%), compared with 22 of the remaining 86 patients (25.6%). Univariate analysis showed an odds ratio of 5.818 (95% CI: 0.996\u0026ndash;33.992), with a Fisher\u0026rsquo;s exact test \u003cem\u003ep\u003c/em\u003e-value of 0.051.\u003c/p\u003e\n\u003ch3\u003ePatch reinforcement:\u003c/h3\u003e\n\u003cp\u003ePatch reinforcement was used in 15 patients (16.3%). Clinically significant Grade B POPF was observed in 5 of these 15 patients (33.3%), compared with 21 of the remaining 77 patients (27.3%). Univariate analysis showed an odds ratio of 1.33 (95% CI: 0.408\u0026ndash;4.360), with a Fisher\u0026rsquo;s exact test \u003cem\u003ep\u003c/em\u003e-value of Of the 15 patients, 3 were Autologous (falciform ligament), 2 where biomesh, and 10 were collagen-based (Hemopatch or Tachosil). The 5 observed Grade B POPF cases occurred in the collagen patch group.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eSealant:\u003c/h2\u003e \u003cp\u003eSealant was applied in 40 patients (43.5%). Clinically significant Grade B POPF was observed in 8 of these 40 patients (20%), compared with 18 of the remaining 52 patients (34.6%). Univariate analysis showed an odds ratio of 0.467 (95% CI: 0.180\u0026ndash;1.237) with a p-value of 0.175 (Fisher\u0026rsquo;s exact test). Among the 40 patients receiving sealant, 12 received cyanoacrylate-based glue (1 leak observed), 27 received fibrin-based glue (7 leaks observed), and 1 received a gelatin-thrombin matrix-based glue (no leak observed).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eConfounders\u003c/h2\u003e \u003cp\u003eA multivariable logistic regression model was used to examine the association between staple line reinforcement and clinically significant Grade B POPF, adjusting for BMI, age, surgical approach, diabetes, and smoking status. Seamguard staple line reinforcement was associated with lower odds of Grade B POPF (OR\u0026thinsp;=\u0026thinsp;0.239, 95% CI: 0.070\u0026ndash;0.813, p\u0026thinsp;=\u0026thinsp;0.022) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Hand oversuturing however was associated with higher odds of Grade B POPF (OR: 8.576, 95% CI: 1.074\u0026ndash;68.475, p\u0026thinsp;=\u0026thinsp;0.043). The application of additional reinforcement techniques (sealants, patch reinforcement, or oversuturing) was not associated with significant changes in the observed relationship with staple line reinforcement (OR: 0.26 ; p\u0026thinsp;=\u0026thinsp;0.024; 95% CI 0.08\u0026ndash;0.840) (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eMultivariate Regression analysis of Staple Line Reinforcement technique\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConfounding factor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOdds ratio\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95% Confidence Intervals\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.991\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.959\u0026ndash;1.024\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.582\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.023\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.940\u0026ndash;1.113\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.604\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSex (Male)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e1.077\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.376\u0026ndash;3.090\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.890\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFinal Surgical Approach (Robotic)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e0.518\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.127\u0026ndash;2.604\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.472\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFinal Surgical Approach (Open)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e1.964\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.656\u0026ndash;5.884\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.228\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSmoking\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e1.224\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.295\u0026ndash;5.073\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.781\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e0.623\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.165\u0026ndash;2.352\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.485\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eStaple Line Reinforcement\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e0.239\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.070\u0026ndash;0.813\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.022\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eThis analysis takes into consideration various pancreatic stump reinforcement techniques that may contribute towards clinically significant leaks - p values of Wald\u0026rsquo;s test is presented here\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eMultivariate Regression analysis of all pancreatic stump buttressing techniques\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConfounding factor\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOdds ratio\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95% Confidence Intervals\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStaple Line Reinforcement\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.260\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.080\u0026ndash;0.840\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.024\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatch enforcement\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.407\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.083\u0026ndash;1.983\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.266\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHand suture\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e8.576\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e1.074\u0026ndash;68.475\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.043\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSealant\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e0.421\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e0.083\u0026ndash;1.983\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e0.105\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eThis analysis takes into consideration various pancreatic stump reinforcement techniques that may contribute towards clinically significant leaks - p values of Wald\u0026rsquo;s test is presented here\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003ePostoperative pancreatic fistula (POPF) following distal pancreatectomy has been reported in up to 40% of cases \u003csup\u003e9\u003c/sup\u003e, with clinically significant leaks (Grade B) observed in approximately 20.2% and Grade C in 1.6%. in some series\u003csup\u003e5\u003c/sup\u003e. In this cohort, the overall POPF rate was approximately 37%, with 8.7% Grade A biochemical leaks and 28.3% Grade B leaks; no Grade C leaks were observed. The observed rate of Grade B POPF 34.5% in open procedures and 25.4% in minimally invasive approaches (laparoscopic and robotic) as shown in Fig.\u0026nbsp;1.\u003c/p\u003e \u003cp\u003eStapler-assisted pancreatic transection was used in all cases in this series. While this technique is commonly employed in minimally invasive distal pancreatectomy, randomized controlled trials and systematic reviews have not demonstrated a consistent difference in POPF rates compared with hand-sutured closure. For example, Kho et al. (2024) observed no significant difference in POPF rates between staple closure and suture closure in a small cohort of patients (n\u0026thinsp;=\u0026thinsp;36) undergoing robotic distal pancreatectomy \u003csup\u003e13\u003c/sup\u003e. A larger meta-analysis by Zhou et al. (2010), comprising 16 articles (n\u0026thinsp;=\u0026thinsp;2286), also found no significant difference in patients undergoing robotic DP; however, most centers are embracing the use of staple transection \u003csup\u003e14\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eStaple line reinforcement with bioabsorbable material (Seamguard) has been evaluated in multiple meta-analysis and studies. Some reports, including Jensen et al. (2013), in a meta-analysis of 483 patients, Oweira et al. (2022), and Jimenez et al. (2007) have described lower POPF rates with reinforcement, while others such as Wennerblom et. al (2021) in a multicentre RCT (n\u0026thinsp;=\u0026thinsp;106) found no significant difference between reinforced and non-reinforced staple transection (6).\u003c/p\u003e \u003cp\u003eIn this cohort, univariate analysis showed a lower observed rate of Grade B POPF with seamguard reinforcement (23% vs 50% without; OR 0.298, 95% CI 0.102\u0026ndash;0.870, p\u0026thinsp;=\u0026thinsp;0.026). The pattern persisted in multivariable logistic regression adjusting for age, sex, BMI, diabetes, smoking status, and surgical approach (OR 0.239, 95% CI 0.071\u0026ndash;0.813, p\u0026thinsp;=\u0026thinsp;0.022) as shown in Table \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eAdditional reinforcement techniques (patch reinforcement using autologous or synthetic materials or fibrin-based sealants) were used selectively. Published meta-analysis and trials have reported mixed findings. A 2024 meta-analysis by Chaouch et al., encompassing 9 studies (n\u0026thinsp;=\u0026thinsp;740), observed that synthetic reinforcement patches (excluding fibrin-based types) were associated with lower incidence of POPF following distal pancreatectomy. However, no benefit was observed in terms of reoperation rates or length of hospital stay (16). On the other hand, fibrin-based sealants and combined patch-sealant approaches often showed no significant association (Mungroop et al. 2020; Bubis et al. 2021; Deng et al. in 2020).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis observational cohort study observed a lower incidence of clinically significant postoperative pancreatic fistula (Grade B POPF) in association with staple line reinforcement with bioabsorbable products such as SeamGuard during distal pancreatectomies. This pattern was present after adjustment for patients-related factors such as age, BMI, diabetes, and smoking status, as well as surgical approach. This observed association with seamguard remained consistent even when additional buttressing techniques (such as hand suturing, autologous or synthetic patch application or even fibrin based sealant application) were used concurrently.\u003c/p\u003e \u003cp\u003eFurther studies using larger sample sizes in prospective or randomised controlled designs, are required to explore the relationship between pancreatic stump management techniques and POPF rates. Such investigations should consider additional factors including stapler cartridge selection, intraoperative pancreatic texture assessment, mani pancreatic duct diameter, and radiographic pancreatic density measures to support more individualized approaches to stump closure.\u003c/p\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eLimitations:\u003c/h2\u003e \u003cp\u003eA key limitation of this study is the relatively small cohort size (n\u0026thinsp;=\u0026thinsp;92), which resulted in a limited number of clinically significant outcome events (Grade B POPF) and consequently reduced statistical power. This limited the ability to include a larger number of variables in a single multivariable model. To address this, two separate multivariate models were constructed; however, splitting the analysis may have reduced the overall robustness of the findings.\u003c/p\u003e \u003cp\u003eAs a retrospective study model, this investigation is also subject to selection bias. The choice of stump closure and reinforcement technique was influenced by intra-operative observations (such as pancreatic transection line thickness and tissue texture) which were not consistently available for inclusion in the analysis.\u003c/p\u003e \u003cp\u003eTherefore, the observed associations between Seamguard reinforcement and lower rates of clinically significant POPF cannot establish causality. Prospective studies, ideally in the form of randomised controlled trials are required to further investigate these relationships. Such study should account for factors that may influence the selection of reinforcement techniques, including pancreatic neck thickness, pancreatic texture, main pancreatic duct diameter, and radiographic measures of pancreatic parenchymal quality.\u003c/p\u003e \u003c/div\u003e "},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eDisclosure statement:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors of this paper declare no conflicts of interest. No financial support or potential for monetary gain was received in relation to this project.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Approval:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrior to commencing data collection for this project, the authors obtained formal approval from the South Metropolitan Health Service Governance, Evidence, Knowledge, and Outcomes (GEKO) system. According to the National Statement on Ethical Conduct in Human Research, this project is classified as low to negligible risk. Upon completion of the report - the results and conclusion were reviewed by the General Surgical subcommittee of GEKO and approved for publication (Reference no. 56644).\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eNazmus Sakib conceptualised the research protocol, collected the data, oversaw the data analysis and the drafting of the manuscript.Mayank Bhandari conceptualised the research protocol, authorised and approved the data analysis and audited the manuscript.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data underlying this study are not publicly available due to institutional governance and patient confidentiality requirements but may be made available from the corresponding author upon reasonable request and with appropriate institutional approvals.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003e1. Harrington KA, Shukla-Dave A, Paudyal R, Do RKG. MRI of the Pancreas. Journal of Magnetic Resonance Imaging. 2020 Apr 17;53(2):347\u0026ndash;59.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e2. Kleeff J, Diener MK, Z\u0026rsquo;graggen K, Hinz U, Wagner M, Bachmann J, et al. Distal Pancreatectomy. Annals of Surgery. 2007 Apr;245(4):573\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e3. Mohammed Abu Hilal, Maarten Korrel, Jones L, Jony van Hilst, Bergthor Bj\u0026ouml;rnsson, Boggi U, et al. Minimally Invasive versus Open Distal Pancreatectomy for Resectable Pancreatic Cancer (DIPLOMA): an International Randomised trial. Journal of Clinical Oncology. 2023 Jun 1;41(16_suppl):4163\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e4. de Rooij T, van Hilst J, van Santvoort H, Boerma D, van den Boezem P, Daams F, et al. Minimally Invasive Versus Open Distal Pancreatectomy (LEOPARD). Annals of Surgery. 2019 Jan;269(1):2\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e5. Chong E, Ratnayake B, Lee S, French JJ, Wilson C, Roberts KJ, et al. Systematic review and meta-analysis of risk factors of postoperative pancreatic fistula after distal pancreatectomy in the era of 2016 International Study Group pancreatic fistula definition. HPB. 2021 Aug;23(8):1139\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e6. Meierhofer C, Reinhold Fuegger, Biebl M, Rainer Schoefl. Pancreatic Fistulas: Current Evidence and Strategy\u0026mdash;A Narrative Review. Journal of Clinical Medicine. 2023 Jul 31;12(15):5046\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e7. McMillan MT, Christein JD, Callery MP, Behrman SW, Drebin JA, Hollis RH, et al. Comparing the burden of pancreatic fistulas after pancreatoduodenectomy and distal pancreatectomy. Surgery. 2016 Apr 1;159(4):1013\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e8. Jensen EH, Portschy PR, Chowaniec J, Teng M. Meta-analysis of Bioabsorbable Staple Line Reinforcement and Risk of Fistula Following Pancreatic Resection. Journal of Gastrointestinal Surgery. 2013 Feb;17(2):267\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e9. Erdem-Sanchez S, M\u0026uuml;ller PC, K\u0026uuml;mmerli C, Hannosch\u0026ouml;ck A, Billeter AT, M\u0026uuml;ller BP. International Validation of the Distal Pancreatectomy Fistula Risk Score \u0026ndash; More Than a Throw of the Dice? British Journal of Surgery [Internet]. 2025 May [cited 2025 Sep 18];112(Supplement_7). Available from: https://doi.org/10.1093/bjs/znaf092.043\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e10. Kho J, Hamady Z, Arshad A. HPB SO12 - Comparison of outcomes between stapled closure and sutured closure of pancreatic stump following robotic distal pancreatectomy. British journal of surgery [Internet]. 2024 Nov 1 [cited 2025 Sep 18];111(Supplement_9). Available from: https://doi.org/10.1093/bjs/znae271.245\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e11. Zhou W, Ran Lv, Wang X, Mou Y, Cai X, Herr I. Stapler vs suture closure of pancreatic remnant after distal pancreatectomy: a meta-analysis. The American Journal of Surgery. 2010 Jun 11;200(4):529\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e12. Hani Oweira, Alessandro Mazotta, Mehrabi A, Christoph Reissfelder, Nuh Rahbari, Betzler A, et al. Using a Reinforced Stapler Decreases the Incidence of Postoperative Pancreatic Fistula After Distal Pancreatectomy: A Systematic Review and Meta-Analysis. World Journal of Surgery. 2022 May 7;46(8):1969\u0026ndash;79.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e13. Jimenez RE, Arun Mavanur, Macaulay WP. Staple Line Reinforcement Reduces Postoperative Pancreatic Stump Leak After Distal Pancreatectomy. Journal of Gastrointestinal Surgery. 2007 Feb 15;11(3):345\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e14. J Wennerblom, Z Ateeb, C J\u0026ouml;nsson, B Bj\u0026ouml;rnsson, B Tingstedt, C Williamsson, et al. Reinforced versus standard stapler transection on postoperative pancreatic fistula in distal pancreatectomy: multicentre randomized clinical trial. British journal of surgery [Internet]. 2021 Jan 1 [cited 2025 Sep 18];108(3):265\u0026ndash;70. Available from: https://doi.org/10.1093/bjs/znaa113\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e15. Mohamed Ali Chaouch, Chadli Dziri, Selman Uranues, Fingerhut A. Pancreatic stump closure after distal pancreatectomy: Systematic review and meta-analysis of randomized clinical trials comparing non-autologous versus no reinforcement: Value of prediction intervals. The American journal of surgery. 2024 Mar 1;229:92\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e16. Mungroop TH, Heijdeon N van der, Buschon OR, Hinghon IH de, Scheeperson JJ, Dijkgraafon MG, et al. Randomized clinical trial and meta-analysis of the impact of a fibrin sealant patch on pancreatic fistula after distal pancreatectomy: CPR trial. British Journal of Surgery. 2021 May;5(3).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e17. Bubis LD, Ramy Behman, Roke R, Serrano PE, Khalil JA, Coburn NG, et al. PATCH-DP: a single-arm phase II trial of intra-operative application of HEMOPATCH\u0026trade; to the pancreatic stump to prevent post-operative pancreatic fistula following distal pancreatectomy. HPB. 2021 Jun 9;24(1):72\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003e18. Deng Y, He S, Cheng Y, Cheng N, Gong J, Gong J, et al. Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery. Cochrane library. 2020 Mar 11;2020(3).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Pancreatectomy, Surgical Stapling, Pancreatic fistula, Retrospective Study, Surgical Mesh","lastPublishedDoi":"10.21203/rs.3.rs-9159586/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9159586/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eIntroduction: Postoperative pancreatic fistula (POPF) remains the most significant complication following distal pancreatectomy. Various pancreatic stump reinforcement techniques have been described, but evidence on their efficacy is conflicting and heterogeneous. The consequent uncertainty therefore limits the development of standardised and patient-tailored management strategies in clinical practices. This retrospective observational study aims to assess the association between the use of bioabsorbable staple-line reinforcement and the development of clinically relevant POPF after distal pancreatectomy within a large Western Australian tertiary care centre.\u003c/p\u003e \u003cp\u003eMethod: This retrospective cohort study analysed patients undergoing distal pancreatectomy at Fiona Stanley Hospital (January 2015\u0026ndash;March 2025), grouped by surgical technique at the surgeon\u0026rsquo;s discretion. The primary outcome was clinically relevant POPF as per the ISGPS definition. Multivariable logistic regression was conducted to evaluate the independent association between stump closure techniques (with particular focus on bioabsorbable staple-line reinforcement) and clinically relevant POPF, while controlling for patient-related risk factors including age, sex, body mass index, diabetes mellitus, smoking status, ASA score, and underlying pathology. Anatomic risk factors such as pancreatic texture, main pancreatic duct diameter, and stump thickness were not included in the model, as these were not routinely documented in medical records.\u003c/p\u003e \u003cp\u003eResults: A total of 92 patients were analysed. The Seamguard reinforcement group (n\u0026thinsp;=\u0026thinsp;74) had a lower incidence of Grade B POPF (23%) compared to those without reinforcement (n\u0026thinsp;=\u0026thinsp;18; 50%). This protective association remained significant after adjusting for age, sex, BMI, diabetes, smoking status, and surgical approach (OR: 0.239; p\u0026thinsp;=\u0026thinsp;0.022) and was unaffected by additional buttressing techniques (OR: 0.260; p\u0026thinsp;=\u0026thinsp;0.024).\u003c/p\u003e \u003cp\u003eConclusion: This observational study suggests staple line reinforcement with Seamguard is associated with lower rates of clinically relevant POPF, and this association appears independent of additional buttressing techniques and patient related risk factors. Further investigation of this association in relation to pancreatic anatomic factors, including thickness, texture and main pancreatic duct size, is needed to develop a standardised patient-tailored approach to minimising POPF incidence.\u003c/p\u003e","manuscriptTitle":"Stapled Transection with Seamguard and Postoperative Pancreatic Fistula After Distal Pancreatectomy: A 10-year single centre experience","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-12 07:39:50","doi":"10.21203/rs.3.rs-9159586/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"82e7bcbb-587a-45a5-8861-ed19264ea2ad","owner":[],"postedDate":"April 12th, 2026","published":true,"recentEditorialEvents":[{"type":"decision","content":"Rejected","date":"2026-05-05T03:56:17+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-05-01T14:18:11+00:00","index":22,"fulltext":""},{"type":"reviewerAgreed","content":"238632999220795100284815148175569530555","date":"2026-05-01T07:39:14+00:00","index":21,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-05T04:09:29+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-12 07:39:50","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9159586","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9159586","identity":"rs-9159586","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}