Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas
Recruiting
Phase 3
Interventional Study
Pancreatic Cancer
Periampullary Cancer
Duodenal Cancer
Cholangiocarcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Head Mass
Bile Duct Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 194 (estimated)
- Sponsor
- Minia University · Other
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.
* Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
* Age 18-75 years .
* Eastern Cooperative Oncology Group (ECOG) performance status 0-…
Contacts