External Pancreatic Stent in Pancreaticojejunostomy

Last updated: April 20, 2026
Sponsor: Minia University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Disorders

Treatment

Pancreaticojejunostomy without external stent

external pancreatic drainage

Pancreaticojejunostomy with external stent

Clinical Study ID

NCT06743516
1282/10/2024
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing pancreaticoduodenectomy (Whipple procedure) for variousindications (e.g., pancreatic cancer, ampullary cancer, etc.).

  • Patients with a confirmed soft pancreas texture, as determined intraoperatively bythe surgeon.

Exclusion

Exclusion Criteria:

  • Patients with a hard or fibrotic pancreas, as determined intraoperatively by thesurgeon.

  • Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severecardiovascular disease, renal failure).

  • Pregnancy or lactation.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Pancreaticojejunostomy without external stent
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
July 01, 2026

Study 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.

Connect with a study center

  • Liver and GIT hospital / Minia university

    Minya, Mallawi 61519
    Egypt

    Active - Recruiting

  • Liver and GIT hospital , Minia University

    Minya, 61519
    Egypt

    Active - Recruiting

  • Saleh Khairy Saleh

    Minya, 61519
    Egypt

    Active - Recruiting

  • Liver and GIT hospital , Minia University

    Minya 360686, 61519
    Egypt

    Site Not Available

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