An interventional study of Pancreaticojejunostomy with external stent and Pancreaticojejunostomy without external stent in Pancreatic Fistula, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Minia University · Not applicable, Interventional, and Prevention
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.
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.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Procedure: Pancreaticojejunostomy with external stent
Pancreaticojejunostomy without stent
Procedure: Pancreaticojejunostomy without external stent
Inserting ureteric stent at the pancreaticojejunostomy site
Only Pancreaticojejunostomy without inserting external stent
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)
evidence of intra abdominal collection
confirmed by abdominal ultrasound and abdominal computed tomography
Time frame: first week, second week postoperative
Started Jan 2025 (actual). Primary completion is estimated for Aug 2026, 19 months after the start.
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