CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 194 target
Drug / intervention
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) +1 moredrug
Likely dose
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) 1.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07155525
NCT07155525Phase 3RecruitingOn TrackUpdated 9mo ago
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Pancreaticojejunostomy With or Without Modified N-butyl-2-cyanoacrylate Following Pancreaticoduodenectomy in Soft Pancreas: Randomized Controlled Trial

Minia University·interventional·Posted Sep 4, 2025·Updated Sep 18, 2025

In Brief

A Phase 3 clinical trial evaluating Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) and Standard(duct-to-mucosa) Pancreaticojejunostomy for Pancreatic Cancer and 6 related conditions. Currently recruiting, targeting 194 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer, Periampullary Cancer, Duodenal Cancer, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Head Mass, Bile Duct Cancer
CountriesEgypt
Collaborators--

Timeline

Phase 3Recruiting
202620272028
First PostedSep 4, 2025
Enrollment StartSep 15, 2025
Primary CompletionSep 15, 2028
Study CompletionNov 15, 2028
TodayJul 1, 2026
Enrollment to primary: 3 yearsPosted 10 months agoPrimary completion in 2.2 years

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) Pancreaticojejunostomyprocedure

* 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