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Clinical Trials/NCT06743516
NCT06743516RecruitingNot Applicable

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

Minia University1 site in 1 country100 target enrollmentStarted: January 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
evidence of pancreatic fistula

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Pancreaticojejunostomy with External stent

Active Comparator

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.

Intervention: Pancreaticojejunostomy with external stent (Procedure)

Pancreaticojejunostomy without stent

Active Comparator

Pancreaticojejunostomy without stent

Intervention: Pancreaticojejunostomy without external stent (Procedure)

Outcomes

Primary Outcomes

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

  • evidence of intra abdominal collection(first week, second week postoperative)

Investigators

Sponsor
Minia University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saleh Khairy Saleh MD

Lecturer

Minia University

Study Sites (1)

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