External Pancreatic Stent in Pancreaticojejunostomy

The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Procedure: Pancreaticojejunostomy without external stent; Procedure: Pancreaticojejunostomy with external stent

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saleh K Khairy, MD; Phone Number: +2 01201765401; Email: salehkhairy@mu.edu.eg
• Study Contact Backup: Name: Anton F Basali, MBBCH; Phone Number: +2 0102707797; Email: Tony_fayez@yahoo.com

Study Locations

• Egypt
  • Minya, Egypt, 61519
    • Recruiting
    • Liver and GIT hospital , Minia University
    • Contact: Saleh K Saleh, MD; Phone Number: +2 01201765401; Email: salehkhairy@mu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pancreaticojejunostomy with External stent; 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; Inserting ureteric stent at the pancreaticojejunostomy site
Active Comparator: Pancreaticojejunostomy without stent	Procedure: Pancreaticojejunostomy without external stent; Only Pancreaticojejunostomy without inserting external stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
evidence of intra abdominal collection	confirmed by abdominal ultrasound and abdominal computed tomography	first week, second week postoperative

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Saleh K Saleh, MD, Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Pancreatic Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Signs and Symptoms; Pancreatic Fistula; Surgical Procedures, Operative; Digestive System Surgical Procedures; Anastomosis, Surgical; Pancreaticojejunostomy
• Other Study ID Numbers: 1282/10/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No