NCT07230509RecruitingPhase 2
Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Minia University
- Diseases
- Pancreatic cancer
- NCT number
- NCT07230509
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 1 Dec 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring left, central or total pancreatectomy or other palliative surgery.
- Patients with vascular invasion and requiring vascular resection.
Other illness
- Known hypersensitivity to cyanoacrylate or Lipiodol®.
- Active infection at the surgical site.
- Unfit patients for surgery due to severe medical illness.
- Patients with serious mental disorders.
Other
- Extremely hard, fibrotic pancreas.
- Significant pancreatitis involving the pancreatic remnant.
- Uncontrolled coagulopathy.
- Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- Irresectable tumors in diagnostic laparoscopy.
- Pregnant or breastfeeding women.
- Patients refused to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liver and GIT hospital , Minia University Coordinator of this site? Confirm its status | Minya | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.