Ligation of pancreatic stump with quantified force during distal pancreatectomy for postoperative pancreatic fistula: study protocol for a single center non-randomized controlled clinical study. (Preprint)

BACKGROUND The closure of pancreatic stump after distal pancreatectomy remains controversial. Currently, the main methods of pancreatic stump closure include manual suturing and stapler closure. However, both methods carry a high risk of postoperative pancreatic fistula, which may be associated with the difficulty of balancing the provision of sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. OBJECTIVE This study aims to investigate whether the ligation of the pancreatic stump with quantified force can decrease the risk of postoperative pancreatic fistula following distal pancreatectomy. METHODS This is a non-randomized controlled clinical study at a tertiary centre in China. The major eligibility criterion is the presence of lesions planned for distal pancreatectomy. The pancreas will be ligated at 5 mm from the pancreatic stump with a quantified force to provide a pancreatic duct burst pressure of approximately 40-70 mmHg. The pancreas will be severed using energy-based devices before or after the ligation. Postoperative regular follow-up will be performed. The primary outcomes includes postoperative pancreatic fistula and postoperative hospital stay, and the secondary outcomes includes intra-abdominal infection, incision infection, and postoperative treatment costs. The primary outcomes and secondary outcomes of patients in this cohort will be statistically compared using appropriate tests. RESULTS The study started in Feb 2025 and the recruiting time is from Feb 2025 to Sep 2025. CONCLUSIONS This protocol proposes a novel approach for pancreatic stump management aimed at preventing postoperative pancreatic fistula following distal pancreatectomy. The research team established the optimal ligation force for the pancreatic stump to ensure adequate burst pressure for the pancreatic duct while preventing acute stump necrosis, thereby theoretically reducing the risk of postoperative pancreatic fistula. CLINICALTRIAL ChiCTR.org Registry ChiCTR2500097781;https://www.chictr.org.cn/showproj.html?proj=247008