Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate) (NBCA)

Minia University

Status and phase

Enrolling

Phase 1

Conditions

Periampullary Cancer

Pancreas Cancer

Postoperative Pancreatic Fistula

Pancreaticoduodenectomy

Treatments

Drug: Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)

Study type

Interventional

Funder types

Other

Identifiers

NCT07132541

1606/07/2025

Details and patient eligibility

About

This study 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.

Full description

Postoperative pancreatic fistula (POPF) remains one of the most significant complications following pancreaticoduodenectomy (PD), with rates ranging from 10% to 30% depending on pancreatic texture and duct size. This study aims to evaluate the use of Histoacryl®, a tissue adhesive, injected into the pancreatic parenchyma to seal leaks and reinforce the anastomotic suture line, particularly in soft pancreases. The study will assess the safety, feasibility, and impact on clinically relevant POPF rates while maintaining exocrine drainage and minimizing parenchymal leakage. Thirty consecutive patients undergoing PD for pancreatic cancer, periampullary cancer, cholangiocarcinoma, or duodenal cancer will be enrolled between July 2025 and July 2026. Preoperative, intraoperative, and postoperative data will be collected and analyzed.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.