External Pancreatic Stent in Pancreaticojejunostomy

ConditionPancreatic Fistula

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMinia University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Pancreaticojejunostomy with external stent
Procedure/Surgery
Inserting ureteric stent at the pancreaticojejunostomy site
Pancreaticojejunostomy without external stent
Procedure/Surgery
Only Pancreaticojejunostomy without inserting external stent

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Pancreaticojejunostomy with External stentActive comparator 1 intervention

Group B: Pancreaticojejunostomy without stentActive comparator 1 intervention

Trial outcomes

Primary outcomes

evidence of pancreatic fistula

confirmed by serum and drain amylase

Time frame

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

Secondary outcomes

evidence of intra abdominal collection

confirmed by abdominal ultrasound and abdominal computed tomography

Time frame

first week, second week postoperative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Source ClinicalTrials.gov

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