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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The prognostic value of external vs internal pancreatic duct stents after pancreaticoduodenectomy remains controversial. This study aimed to evaluate the benefits of external and internal stents using the Updated Alternative Fistula Risk Score in both high-risk and low-risk patients with regard to the incidence of clinically relevant postoperative pancreatic fistula.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed;

⁃ The patient has no combined organic diseases in the heart, lungs, or kidneys;

‣ No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors; ④ The risk score of the pancreatic fistula of the patient according to the definition of the updated Alternative Fistula Risk Score (ua-FRS). Patients with a ua-FRS score higher than 5% were included in this study.

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITING
Hangzhou
Contact Information
Primary
Sheng Yan, Doctor
shengyan@zju.edu.cn
13957161680
Backup
Guogang Li, Doctor
liguogangnag@163.com
13819198620
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2026-08
Participants
Target number of participants: 300
Treatments
Experimental: external pancreatic duct stent
Experimental: internal pancreatic duct stent
Sponsors
Collaborators: The Third Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital, Linping First People's Hospital, Ningbo No. 1 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov