Tissue-glue injection into the pancreas during pancreaticoduodenectomy
Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial
This trial will test whether injecting a tissue glue called N-butyl-2-cyanoacrylate into the pancreatic remnant during pancreaticoduodenectomy reduces postoperative pancreatic fistulas in patients with a soft pancreas and a small main duct.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07230509 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled phase 2 trial that will enroll about 90 patients undergoing pancreaticoduodenectomy for malignant disease and randomly assign them to receive pancreatic parenchymal injection of N-butyl-2-cyanoacrylate (NBCA) or standard pancreaticojejunostomy alone. The primary outcome is the incidence of postoperative pancreatic fistula (POPF) using ISGPS definitions, with secondary outcomes including length of hospital stay, readmission, reoperation, mortality, and other postoperative complications. The intervention uses NBCA, a tissue adhesive with hemostatic and sealing properties, delivered into the pancreatic parenchyma during the anastomosis. The trial is single-center at Minia University and targets patients with soft pancreatic texture and a main duct diameter under 3 mm.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing pancreaticoduodenectomy with curative intent for pancreatic or periampullary cancers who have a soft pancreas, a main pancreatic duct under 3 mm, and are medically fit to consent and undergo surgery.
Not a fit: Patients with a hard fibrotic pancreas, large ducts, active pancreatic remnant pancreatitis, distant metastases, vascular invasion requiring resection, or those unfit for surgery are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this technique could lower rates of postoperative pancreatic fistula, shorten hospital stays, and reduce reoperations and other complications.
How similar studies have performed: NBCA and other tissue adhesives have been used successfully in various surgical settings and small case series suggest potential benefit for sealing pancreatic tissue, but randomized controlled evidence specifically in pancreaticoduodenectomy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines. * Soft pancreatic texture. * Small main pancreatic duct diameter (\<3 mm). * Informed consent obtained. Exclusion Criteria: * Known hypersensitivity to cyanoacrylate or Lipiodol®. * Extremely hard, fibrotic pancreas. * Significant pancreatitis involving the pancreatic remnant. * Active infection at the surgical site. * Uncontrolled coagulopathy. * Unfit patients for surgery due to severe medical illness. * Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. * Irresectable tumors in diagnostic laparoscopy. * Patients requiring left, central or total pancreatectomy or other palliative surgery. * Pregnant or breastfeeding women. * Patients with serious mental disorders. * Patients with vascular invasion and requiring vascular resection. * Patients refused to participate in the study.
Where this trial is running
Minya, Minya Governorate
- Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.