Saleh's technique: injecting Histoacryl glue into the pancreas during pancreaticojejunostomy
Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique
This procedure will try injecting a tissue glue (Histoacryl) into the pancreas during pancreaticoduodenectomy to see if it reduces pancreatic leaks in people with a soft pancreas and a small pancreatic duct.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07132541 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study injects N-butyl-2-cyanoacrylate (Histoacryl) into the pancreatic parenchyma at the time of pancreaticojejunostomy in patients undergoing pancreaticoduodenectomy who have a soft pancreas and a main duct under 3 mm. Thirty consecutive patients having curative-intent resection for pancreatic, periampullary, cholangiocarcinoma, or duodenal cancer will be enrolled at Minia University between July 2025 and July 2026. The trial's primary focus is safety and feasibility, with systematic collection of preoperative, intraoperative, and postoperative data and monitoring for clinically relevant postoperative pancreatic fistula (POPF) and other complications. Secondary observations include preservation of exocrine drainage, technical performance of parenchymal injection, and rates of parenchymal leakage.
Who should consider this trial
Good fit: Ideal candidates are patients planned for pancreaticoduodenectomy for curative-intent malignancy who have a soft pancreatic texture, a main pancreatic duct diameter under 3 mm, and can provide informed consent.
Not a fit: Patients with a hard or fibrotic pancreas, large pancreatic ducts, active infection, uncontrolled coagulopathy, distant metastases, or who are unfit for surgery are not candidates and are unlikely to benefit from this technique.
Why it matters
Potential benefit: If successful, the technique could lower clinically significant postoperative pancreatic fistula rates and the complications that follow after pancreaticoduodenectomy.
How similar studies have performed: Use of cyanoacrylate and other tissue adhesives to reinforce pancreatic anastomoses is relatively novel with only limited case series and no large randomized trials demonstrating clear benefit to date.
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.