Pancreatic CancerPeriampullary CancerDuodenal CancerCholangiocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Head MassBile Duct Cancer
Investigational drug(s) / intervention(s)
Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)Standard(duct-to-mucosa) Pancreaticojejunostomy
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
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
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 0-2.
* Adequate organ function defined as:
Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal
* Informed consent provided.
* Willingness to comply with study procedures and follow-up requirements.
Exclusion Criteria:
* Hard pancreatic texture (intraoperative surgeon assessment).
* Emergency surgery.
* Previous pancreatic surgery or pancreatic anastomosis.
* Intraoperative identification of unresectable disease
* Known allergy to cyanoacrylate or components.
* Pregnancy or lactation.
* Active infection or sepsis.
* Inability to comply with follow-up.
Primary outcome measure(s)
Incidence of Postoperative Pancreatic Fistula (POPF). — 30 days post-surgery. Percentage of patients developing postoperative pancreatic fistula as defined by International Study Group on Pancreatic Fistula (ISGPF) criteria. POPF is defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the upper normal serum value. Graded as A (biochemical leak), B , or C.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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