Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
Recruiting · NCT07230509 · Interventional (participants receive a specific treatment) · Lead sponsor: Minia University
View the official record on ClinicalTrials.gov →Interventions studied
Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.Standard Pancreaticojejunostomy
What this trial is about
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 take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Liver and GIT hospital , Minia University - Minya, Minya Governorate, Egypt