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

Sponsor
Minia University
Study ID
NCT07155525
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) — DRUG
    * 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
  • Standard(duct-to-mucosa) Pancreaticojejunostomy — PROCEDURE
    * 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

Study Details

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.

Key Dates

First listed
Sep 4, 2025
Start date
Sep 15, 2025
Status verified
Sep 2025
Primary completion
Sep 15, 2028
Completion
Nov 15, 2028

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
    Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma.
  • Active Comparator: Standard Pancreaticojejunostomy without tissue adhesive application.
    Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.

Primary Outcome Measure

Incidence of Postoperative Pancreatic Fistula (POPF). [ Time Frame: 30 days post-surgery. ]

Central Contacts

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