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Recruiting Not applicable NCT06743516

External Pancreatic Stent in Pancreaticojejunostomy

No applicable phase (e.g. observational)
Conditions: Pancreatic Fistula

Sponsor: Minia University

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
Pancreaticojejunostomy with external stent
PROCEDURE
Pancreaticojejunostomy without external stent
PROCEDURE
Locations 1
Egypt (1)
Liver and GIT hospital , Minia University
Minya
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.01.2025
Completion date
01.07.2026
Registry ID
NCT06743516
Source
clinicaltrials.gov
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