Actively Recruiting
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-02-13
300
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
N
Ningbo No. 1 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicenter Randomized Controlled Study of External Pancreatic Duct Stents in Pancreaticoduodenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pancreatoduodenectomy with pancreaticojejunal mucosa anastomosis was performed
- No combined organic diseases in the heart, lungs, or kidneys
- No history of chemotherapy, radiotherapy, upper abdominal surgery, or other tumors
- Updated Alternative Fistula Risk Score (ua-FRS) higher than 5%
You will not qualify if you...
- Previous history of other tumors or upper abdominal surgery
- Multiple lesions and distant metastasis
- Organic diseases of important organs such as heart, lung, or kidney preventing surgery
- Age less than 18 years or older than 75 years
- Use of other measures to prevent pancreatic fistula, such as fibrin glue sealing, that may affect the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, China
Actively Recruiting
Research Team
S
Sheng Yan, Doctor
CONTACT
G
Guogang Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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