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

Study acronym: NBCA-MS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Phase changed: Phase 3 → not applicable
    • Eligibility criteria expanded, about 15 words
    • Publications: details revised at 2 of 2 entries
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Publications: details revised at 2 of 2 entries
    v3
  3. Secondary endpoints revised (6)
    • Publications: details revised at 2 of 2 entries
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07155525
Lead Sponsor Minia University
Conditions
(from sponsor)		 Pancreatic Cancer, Periampullary Cancer, Duodenal Cancer, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Head Mass, Bile Duct Cancer
Related terms Bile Duct Neoplasms, Cholangiocarcinoma, Duodenal Neoplasms, Pancreatic Neoplasms
Enrollment 194 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov