External Pancreatic Stent in Pancreaticojejunostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pancreatic Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Surgeons are not blinded due to the intervention's nature; data collectors, assessors, and analysts are blinded.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Pancreaticojejunostomy with external stent

Intervention Type PROCEDURE

Inserting ureteric stent at the pancreaticojejunostomy site

Pancreaticojejunostomy without stent

Group Type ACTIVE_COMPARATOR

Pancreaticojejunostomy without external stent

Intervention Type PROCEDURE

Only Pancreaticojejunostomy without inserting external stent

Interventions

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Pancreaticojejunostomy with external stent

Inserting ureteric stent at the pancreaticojejunostomy site

Intervention Type PROCEDURE

Pancreaticojejunostomy without external stent

Only Pancreaticojejunostomy without inserting external stent

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No