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

NARecruitingINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

May 24, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

February 1, 2027

Conditions
Pancreaticoduodenectomy
Interventions
PROCEDURE

Main pancreatic duct and biliary duct external drainage

"Pancreaticojejunostomy:~Assess pancreatic texture and duct diameter, preparing a 2 cm pancreatic remnant, and securing it to the jejunum's muscular layer using 3-0 prolene for U-shaped anastomosis. A patented drainage tube is inserted into the jejunum for effective drainage. Anastomoses are performed with 4-0 prolene between the pancreatic duct and jejunal mucosa, both posteriorly and anteriorly, with additional reinforcement at the pancreas and jejunum's anterior walls. A Fr6 silicone tube is placed in the distal jejunal remnant and secured.~The drainage system, featuring a one-way valve, connects the internal and external silicone tubes to a drainage bag.~Choledochojejunostomy:~The common bile duct's diameter is noted, and an opening in the jejunum is made for hepatobiliary tract formation with 4-0 absorbable sutures. A Fr10 silicone tube is inserted into the afferent limb and secured. This tube, too, connects to the external drainage system with a one-way valve."

PROCEDURE

Main pancreatic duct and biliary duct internal drainage

"Pancreaticojejunostomy:~Assess the pancreatic texture and pancreatic duct diameter, and reserve the length of the pancreatic remnant to about 1.5 cm. Open the transverse mesocolon and bring the distal small intestinal remnant to the side of the pancreatic remnant. Perform a 2 cm side-to-side pancreaticojejunostomy with an invagination technique. Use a simple full-layer suturing method, 4-0 PDS plus continuous suturing, insert a plastic strip into the pancreatic duct, and fix the pancreatic duct stent with 3/0 Vicryl.~Choledochojejunostomy:~Record the diameter of the common bile duct, about 10 cm away from the pancreaticojejunostomy, and open the jejunum. Form the hepatobiliary tract and perform interrupted anastomosis with 4-0 absorbable sutures."

Trial Locations (1)

200000

RECRUITING

Zhongshan Hospital, Shanghai

All Listed Sponsors
collaborator

Huadong Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

The First People's Hospital of Yunnan

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

lead

Shanghai Zhongshan Hospital

OTHER