Saleh's technique: injecting Histoacryl glue into the pancreas during pancreaticojejunostomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Local complications of acute pancreatitis and postoperative pancreatic fistula: what happens in real life

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.