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

NCT07155525 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pancreaticojejunostomy 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

PROCEDURE

Standard(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

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Saleh K Saleh, MD · Minia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2028-09-15
Completion
2028-11-15

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155525 on ClinicalTrials.gov