Comparing External and Internal Pancreatic Duct Stents to Prevent Pancreatic Fistula After Pancreaticoduodenectomy in Adults

What this Trial Is About

Pancreatic cancer is a serious and often deadly disease, with pancreaticoduodenectomy being the standard treatment for tumors in the pancreatic head and nearby areas. However, this surgery carries a high risk of complications, especially postoperative pancreatic fistula, which can affect 25% to 50% of patients. Researchers are studying whether using external versus internal pancreatic duct stents can lower the risk of these complications, focusing on patients with different levels of risk as determined by the Updated Alternative Fistula Risk Score ua-FRS. The study compares two types of pancreatic duct stents during pancreaticoduodenectomy an external stent, which exits through the abdominal wall, and an internal stent, a silicone catheter placed inside the pancreatic duct and jejunum. All surgeries are performed by the same specialized team using laparoscopic or open approaches, with reconstruction using the childs technique. Patients are assigned randomly to receive either the external or internal stent to evaluate the effect on postoperative outcomes. Participants will be monitored for at least one month after surgery to track the occurrence of clinically relevant postoperative pancreatic fistula CR-POPF and other complications. Assessments include clinical evaluations and follow-up to measure the primary outcome of CR-POPF incidence. The study aims to clarify the safety and effectiveness of external stents in both high-risk and low-risk patients undergoing pancreaticoduodenectomy, with all procedures and outcomes carefully recorded by the research team.

A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy