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

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 2, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

August 31, 2026

Conditions
Pancreatic Fistula
Interventions
PROCEDURE

External pancreatic duct stent

All pancreaticoduodenectomies were performed by the same surgical team at our pancreatic center throughout the study period. According to the preoperative laboratory results, medical imaging data, and intraoperative conditions, the laparoscopic or open pancreaticoduodenectomy, or pylorus-preserving pancreaticoduodenectomy was performed at the discretion of the individual surgeon. The child's technique was implemented to achieve digestive tract reconstruction, and all patients underwent a duct-to-mucosa pancreaticojejunostomy. The external pancreatic duct stent left the other end exteriorized through the proximal jejunum via a small enterotomy that was fixed in the abdominal wall.

PROCEDURE

Internal pancreatic duct stent

All pancreaticoduodenectomies were performed by the same surgical team at our pancreatic center throughout the study period. According to the preoperative laboratory results, medical imaging data, and intraoperative conditions, the laparoscopic or open pancreaticoduodenectomy, or pylorus-preserving pancreaticoduodenectomy was performed at the discretion of the individual surgeon. The child's technique was implemented to achieve digestive tract reconstruction, and all patients underwent a duct-to-mucosa pancreaticojejunostomy. The internal pancreatic duct stent, a silicone catheter with multiple side pores, was inserted into the main pancreatic duct and the other end was placed in the jejunum cavity.

Trial Locations (1)

Unknown

RECRUITING

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou

All Listed Sponsors
collaborator

Ningbo No. 1 Hospital

OTHER

collaborator

Huizhou Municipal Central Hospital

OTHER

collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

collaborator

The Third Affiliated Hospital of Wenzhou Medical University

OTHER

collaborator

Linping First People's Hospital

UNKNOWN

lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER