CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 30 target
Drug / intervention
Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)drug
Likely dose
Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®) 0.2 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/NCT07132541
NCT07132541Phase 1RecruitingOn TrackUpdated 9mo ago
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Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique

Minia University·interventional·Posted Aug 20, 2025·Updated Sep 2, 2025

In Brief

A Phase 1 clinical trial evaluating Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®) for Pancreaticoduodenectomy and 3 related conditions. Currently recruiting, targeting 30 participants across 1 site.

Detailed Summary

This study investigates the safety and efficacy of injecting N-butyl-2-cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreas Cancer, Periampullary Cancer
CountriesEgypt
Collaborators--

Timeline

Phase 1Recruiting
2026
First PostedAug 20, 2025
Enrollment StartAug 25, 2025
Primary CompletionAug 25, 2026
Study CompletionSep 25, 2026
TodayJul 1, 2026
Enrollment to primary: 1 yearPosted 10 months agoPrimary completion in 2 months

Interventions

Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)drug

This procedure is integrated into the standard pancreaticoduodenectomy. Injection of Histoacryl® (n-butyl-2-cyanoacrylate) mixed with Lipiodol® (1:1 ratio) into the pancreatic parenchyma circumferentially (3, 6, 9, and 12 o'clock positions) around the main pancreatic duct (MPD) orifice, extending 5-8 mm deep and 5-10 mm laterally from the future anastomotic line, avoiding the main pancreatic duct and vessels. Total volume injected typically ranges from 0.2 ml to 0.6 ml. Follow with standard duct-to-mucosa pancreaticojejunostomy: * Tying down the posterior duct-to-mucosa sutures. * Placing and tying the anterior duct-to-mucosa sutures. * Tying down the posterior outer layer sutures. * Placing the anterior outer layer sutures. Meticulously avoid glue contact with sutures/mucosa Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).