RecruitingPhase 3NCT07155525

Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas

Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial

Sponsor

Minia University

Enrollment

194 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Cholangiocarcinoma Pancreatic Ductal Adenocarcinoma Bile Duct Cancer Duodenal Cancer Periampullary Cancer Pancreatic Head Mass

Summary

This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether applying a medical-grade glue (called Glubran® 2, a type of cyanoacrylate) to the pancreas during a major surgery called pancreaticoduodenectomy (Whipple procedure) helps prevent a common and serious complication — a pancreatic fluid leak. This issue is more likely when the pancreatic tissue is soft and fragile. **You may be eligible if...** - You are between 18 and 75 years old - You are scheduled for a planned (non-emergency) Whipple surgery for a pancreatic tumor - During surgery, your surgeon confirms your pancreas tissue is soft - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your pancreas tissue is firm/hard (confirmed during surgery) - You need emergency surgery - You have had previous pancreatic surgery - The cancer is found to be too advanced to remove during surgery - You are allergic to cyanoacrylate glue - You are pregnant, breastfeeding, or have an active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)

* Standard duct-to-mucosa pancreaticojejunostomy performed * Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site * Adhesive applied circumferentially around the pancreaticojejunal anastomosis * Allow 2-3 minutes for polymerization before proceeding * Standard placement of peritoneal drains

PROCEDUREStandard(duct-to-mucosa) Pancreaticojejunostomy

* Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy. * Standard placement of peritoneal drains * All other aspects of surgical care identical to experimental arm