An interventional study of Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2) and Standard(duct-to-mucosa) Pancreaticojejunostomy in Pancreatic Cancer, Periampullary Cancer and Duodenal Cancer, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Minia University · Not applicable, Interventional, and Treatment
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.
Postoperative pancreatic fistula (POPF) remains the most common and serious complication following pancreaticoduodenectomy, with incidence rates reaching up to 56.7% in patients with soft pancreatic texture. The soft pancreatic parenchyma is particularly vulnerable to anastomotic breakdown due to its friable nature and difficulty in achieving secure suturing.
N-butyl-2-cyanoacrylate is a biodegradable tissue adhesive that polymerizes rapidly upon contact with hydroxide ions in tissue fluids, forming a strong, flexible bond. The application of modified N-butyl-2-cyanoacrylate to pancreaticoenteric anastomoses may reduce the incidence of POPF by providing additional mechanical reinforcement and sealing of minor leaks.
This is a phase III, single-center, prospective, randomized controlled trial with parallel groups. Eligible patients will undergo intraoperative assessment of pancreatic texture (soft confirmed by surgeon's palpation). Randomization will occur intraoperatively after resection but before reconstruction, using computer-generated blocks.
This study aims to evaluate whether the application of modified N-butyl-2-cyanoacrylate (Glubran® 2) during pancreaticojejunostomy can significantly reduce the incidence of POPF in patients with soft pancreatic texture undergoing pancreaticoduodenectomy. Patients will be randomized to receive either standard pancreaticojejunostomy (control group) or pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate application (intervention group).
The intervention group will receive 1-2 mL of modified N-butyl-2-cyanoacrylate applied topically to the pancreatic stump and anastomosis site during pancreaticojejunostomy. The control group will receive standard duct-to-mucosa pancreaticojejunostomy without adhesive. All patients will receive standardized perioperative care, including prophylactic antibiotics and drain management per ISGPF guidelines.
Follow-up will include daily amylase measurements in drains (days 1,3,5), CT imaging if POPF suspected.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 194 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma.
Drug: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)
Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.
Procedure: Standard(duct-to-mucosa) Pancreaticojejunostomy
* 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
Also known as: Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2
* 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
Also known as: Standard Pancreaticojejunostomy
Incidence of Postoperative Pancreatic Fistula (POPF).
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.
Time frame: 30 days post-surgery.
Time to POPF resolution.
Number of days from surgery to complete resolution of pancreatic fistula.
Time frame: 90 days post-surgery.
Postoperative complications
Incidence of delayed gastric emptying, bile leak, wound infection, intra-abdominal abscess, and other complications.
Time frame: 30 days post-surgery
Reoperation Rate
Percentage of patients requiring reoperation for complications.
Time frame: 90 days post-surgery.
Length of Hospital Stay
Total number of days in hospital following surgery(days).
Time frame: Up to 90 days
Incidence of postpancreatectomy Hemorrhage
Per International Study Group on Pancreatic Fistula (ISGPS) criteria.
Time frame: 30 days post-surgery
Mortality Rate
All-cause mortality.
Time frame: 90 days post-surgery
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Minia University