Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate (NCT07230509) | Clinical Trial Compass
RecruitingPhase 2
Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
Egypt90 participantsStarted 2025-12-01
Plain-language summary
This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.