Actively Recruiting
The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
Led by Minia University · Updated on 2026-04-21
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pancreatic fistula, a serious complication that can occur after pancreatoduodenectomy, especially in patients with a soft pancreas. The study aims to find the best method to prevent pancreatic fistula and to assess the long-term outcomes of these methods. This trial evaluates the use of an external pancreatic duct stent during pancreaticojejunostomy, a surgical connection of the pancreas to the small intestine. Participants will be randomly assigned to one of two groups: one group will receive an external ureteric catheter stent placed at the pancreaticojejunostomy site, which is routed through the jejunal loop and abdominal wall; the other group will undergo pancreaticojejunostomy without a stent. The study will compare these procedures to see which better reduces pancreatic fistula and other complications. During the study, patients will be monitored for signs of pancreatic fistula within the first 7 days after surgery, with specific checks on days 1, 3, and 5. Researchers will also look for intra-abdominal fluid collections during the first two weeks after surgery. The study will follow patients to observe healing, complications, and overall recovery. Participants will provide informed consent before enrollment, and the total study period extends until July 2026.
CONDITIONS
Brief Title
External Pancreatic Stent in Pancreaticojejunostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications such as pancreatic or ampullary cancer
- Patients confirmed to have a soft pancreas texture during surgery
You will not qualify if you...
- Patients with a hard or fibrotic pancreas determined during surgery
- Patients with severe uncontrolled health conditions like diabetes, heart disease, or kidney failure
- Pregnant or breastfeeding women unable to participate safely
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo pancreaticoduodenectomy (Whipple procedure) with or without external pancreatic duct drainage using a ureteric stent.
1 visit (in-person)
Duration - First 7 days after surgery
Participants are monitored closely after surgery for early signs of pancreatic fistula and other complications.
Visits on Day 1, Day 3, and Day 5 (in-person)
Duration - Up to 2 weeks post-surgery
Participants are followed for evidence of intra-abdominal collections and recovery during the first two weeks after surgery.
Visits during first and second week post-operation (in-person)
Trial Site Locations
Total: 1 location
1
Liver and GIT hospital , Minia University
Minya, Egypt, 61519
Actively Recruiting
Research Team
S
Saleh K Khairy, MD
A
Anton F Basali, MBBCH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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