Study of External Drainage of Pancreatic and Bile Ducts to Reduce Pancreatic Fistula After Pancreaticoduodenectomy Surgery

What this Trial Is About

Researchers are studying the effects of external drainage of the main pancreatic duct and common bile duct on postoperative complications, especially pancreatic fistula, following pancreaticoduodenectomy PD. PD is a common surgery for tumors in the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. Although mortality rates have decreased in experienced centers, complications like pancreatic fistula, delayed gastric emptying, and biliary leakage remain frequent and serious concerns. This trial aims to clarify whether external drainage reduces these complications compared to internal drainage, especially in patients at intermediate or high risk of pancreatic fistula. The study compares two surgical methods after PD external drainage using patented silicone tubes with one-way valves for both the pancreatic and biliary ducts, and internal drainage involving sutured anastomoses with stents in the pancreatic duct and bile duct. Each method involves detailed surgical techniques to connect the pancreatic and bile ducts to the jejunum. Participants will be randomly assigned to one of these two groups to assess differences in postoperative outcomes. Participants will be followed for 90 days after surgery to monitor the occurrence of clinically relevant pancreatic fistula and other complications such as bleeding, infection, and delayed gastric emptying. Researchers will also track hospital stay length, treatment costs, reoperation and readmission rates, and long-term survival up to five years. Assessments include clinical evaluations and complication grading to understand the safety and impact of each drainage approach.

Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy