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NCT Number: NCT06743516

External Pancreatic Stent in Pancreaticojejunostomy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liver and GIT hospital , Minia University

Minya, 61519, Egypt

Location status: Recruiting

Location contact

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreaticojejunostomy with external stent

Procedure

Inserting ureteric stent at the pancreaticojejunostomy site

Pancreaticojejunostomy without external stent

Procedure

Only Pancreaticojejunostomy without inserting external stent

Primary outcomes

  1. evidence of pancreatic fistula

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

    confirmed by serum and drain amylase

Secondary outcomes

  1. evidence of intra abdominal collection

    Time frame: first week, second week postoperative

    confirmed by abdominal ultrasound and abdominal computed tomography

Study contacts

Contact information is provided by the study sponsor or research team.

Anton F Basali, MBBCH

CONTACT

[email protected]

0102707797 ext. +2

Saleh K Khairy, MD

CONTACT

[email protected]

01201765401 ext. +2

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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