Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreas Cancer, Periampullary Cancer
In brief
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.
Key facts
- Study ID
- NCT07230509
- Run by
- Minia University
- People needed
- 90
- Starts
- 2025-12-01
- Expected to finish
- 2027-12-20
- Last updated by the study team
- 2025-12-02
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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