External Pancreatic Stent in Pancreaticojejunostomy

NCT06743516 | Recruiting DMC

• 1 other identifier: 1282/10/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

• evidence of pancreatic fistula

  confirmed by serum and drain amylase

  within the first 7 days after surgery( first day, third day and fifth day)

Secondary Outcomes (1)

• evidence of intra abdominal collection

  first week, second week postoperative

Study Arms (2)

Pancreaticojejunostomy with External stent

ACTIVE COMPARATOR

ureteric catheter (7Fr) insert at pancreatojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall.

Procedure: Pancreaticojejunostomy with external stent

Pancreaticojejunostomy without stent

ACTIVE COMPARATOR

Pancreaticojejunostomy without stent

Procedure: Pancreaticojejunostomy without external stent

Interventions

Pancreaticojejunostomy with external stent PROCEDURE

Inserting ureteric stent at the pancreaticojejunostomy site

Pancreaticojejunostomy with External stent

Pancreaticojejunostomy without external stent PROCEDURE

Only Pancreaticojejunostomy without inserting external stent

Pancreaticojejunostomy without stent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Khairy, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Anton F Basali, MBBCH

CONTACT

0102707797; Tony_fayez@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

EG (1)