Ligation of the Pancreatic Stump With Quantified Force During Distal Pancreatectomy for Postoperative Pancreatic Fistula: Protocol for a Single-Center Nonrandomized Controlled Clinical Study

TL;DR

This study tests if using a specific force to ligate the pancreatic stump during surgery can reduce the risk of a serious complication called postoperative pancreatic fistula.

Contribution

The study introduces a novel ligation method with quantified force to manage the pancreatic stump during distal pancreatectomy.

Findings

The study will compare ligation with quantified force to traditional methods for preventing pancreatic fistula.

The optimal ligation force is calculated to provide sufficient burst pressure while avoiding tissue damage.

Outcomes like hospital stay and infection rates will be analyzed to assess the method's effectiveness.

Abstract

The incidence of postoperative pancreatic fistula following distal pancreatectomy is as high as 30%-50%. Postoperative pancreatic fistula can be a major cause of perioperative morbidity, resulting in prolonged hospital stays and increased health care costs. The management of the pancreatic stump is one of the key factors influencing the occurrence of postoperative pancreatic fistula after distal pancreatectomy, but the optimal management approach remains debatable. The main methods for pancreatic stump closure include manual suturing and stapler closure. However, both methods are associated with a high risk of postoperative pancreatic fistula, which may be related to the balance between providing sufficient pancreatic duct burst pressure and ensuring blood supply to the stump. Ligation of the pancreatic stump has been attempted to reduce the risk of postoperative pancreatic fistula following distal pancreatectomy, but its efficacy remains limited by the challenge of achieving the optimal ligation force.

This study aims to investigate whether ligation of the pancreatic stump with a quantified force can decrease the risk of postoperative pancreatic fistula following distal pancreatectomy.

In this nonrandomized controlled clinical study at a tertiary center in China, the major eligibility criterion is the presence of lesions planned for distal pancreatectomy. Sixty patients will be allocated to the experimental or control group according to their choice. Recruitment for either group will be discontinued upon reaching the predefined sample size of 30 participants. In the experimental group, the pancreas will be ligated 5 mm from the pancreatic stump with a quantified force to provide a pancreatic duct burst pressure of approximately 40-70 mm Hg. The ligation force will be provided by a 3.2-mm-diameter silicone ring. During pancreatic stump ligation, this silicone ring will be stretched to 15 mm, generating an applied force of 1.3 N. The pancreas will be severed using energy-based devices before or after the ligation. In the control group, the pancreatic stump will be managed by manual suturing or stapling closure according to the surgeon’s clinical judgment and preference. Postoperative regular follow-up examinations will be conducted. The primary outcomes include postoperative pancreatic fistula and postoperative hospital stay, and the secondary outcomes include intra-abdominal infection, incision infection, and postoperative treatment costs. The primary and secondary outcomes of patients in this cohort will be statistically compared using appropriate tests.

This study started in February 2025, and the recruitment period is from February to September 2025.

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.

Chinese Clinical Trial Register ChiCTR2500097781; https://www.chictr.org.cn/showproj.html?proj=247008

DERR1-10.2196/74018

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