What this Trial Is About

Researchers are investigating the impact of external drainage of the main pancreatic duct and common bile duct on postoperative complications, especially pancreatic fistula, following pancreaticoduodenectomy (PD). PD is the standard surgery for tumors in the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. Advances have lowered mortality rates to under 5% in specialized centers, but postoperative complication rates remain high, especially pancreatic fistula, which can cause serious infections and death. Current treatments to prevent fistula include pancreatic duct stent external drainage and biliary drainage, but their effectiveness is unclear, particularly in patients with varying risk levels of pancreatic fistula. The study compares two approaches: external drainage and internal drainage of the pancreatic and biliary ducts during PD surgery. External drainage involves placing drainage tubes with one-way valves to divert pancreatic and biliary juices outside the body. Internal drainage includes creating a connection (anastomosis) between the ducts and the jejunum without external tubes. Both procedures involve carefully assessing pancreatic texture and duct diameter and use different surgical techniques to connect the pancreas and bile duct to the intestines. Participants will be monitored for 90 days after surgery to track the occurrence of clinically relevant pancreatic fistula and other complications. Researchers will evaluate postoperative outcomes, including fistula rates, and safety measures. Study visits will include clinical assessments, imaging, and laboratory tests to monitor recovery and complications. The goal is to better understand whether external drainage reduces pancreatic fistula risk in patients with intermediate or high risk as determined by a specific scoring system, helping improve treatment after PD surgery.

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