External Pancreatic Stent in Pancreaticojejunostomy

Not Applicable

Recruiting

• Conditions: Pancreatic Fistula

• Registration Number: NCT06743516
• Lead Sponsor: Minia University

Brief Summary

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Detailed Description

The role of external pancreatic duct drainage in managing patients with a soft pancreas is particularly important, as these patients are at a heightened risk of developing postoperative complications. By providing an external route for pancreatic secretions, external pancreatic duct drainage may help to reduce the enzymatic activity at the anastomosis site and promote better healing.

In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent.

•After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.

Study Timeline

• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-20
• Study Start: 2025-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-01-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.).
• Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.

Exclusion Criteria

• Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon.
• Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure).
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
evidence of pancreatic fistula	within the first 7 days after surgery( first day, third day and fifth day)	confirmed by serum and drain amylase

Secondary Outcome Measures

Name	Time	Method
evidence of intra abdominal collection	first week, second week postoperative	confirmed by abdominal ultrasound and abdominal computed tomography

Trial Locations

Locations (1)

Liver and GIT hospital , Minia University; 🇪🇬 Minya, Egypt