Tissue-glue injection into the pancreas during pancreaticoduodenectomy

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 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.

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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  Recruiting at 12 sites Tokyo University · Ōtsu, Shiga and 11 other locations · NCT07862088

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.