Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate (NBCA)

Minia University

Status and phase: Enrolling; Phase 2

Conditions: Periampullary Cancer; Pancreas Cancer; Postoperative Pancreatic Fistula; Pancreaticoduodenectomy

Treatments: Procedure: Standard Pancreaticojejunostomy; Drug: Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.

Study type: Interventional

Funder types: Other

Identifiers

NCT07230509

1703/09/2025

Details and patient eligibility

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.

Full description

This randomized controlled trial aims to evaluate the efficacy of pancreatic parenchymal N-Butyl-2-Cyanoacrylate (NBCA) injection in reducing the incidence and severity of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). POPF remains a major complication of PD, leading to increased morbidity, mortality, and healthcare costs. NBCA, a tissue adhesive, has shown promise in various surgical applications due to its hemostatic and sealing properties. This study will enroll approximately 90 patients undergoing PD, randomly assigning them to either the NBCA injection group or the control group. The primary outcome will be the incidence of POPF according to the International Study Group on Pancreatic Surgery (ISGPS) definition. Secondary outcomes includes length of hospital stay, readmission rates, reoperation rates, mortality, and other postoperative complications. This trial is designed to provide high level evidence regarding the utility of NBCA in improving outcomes after PD.

Enrollment: 90 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.

Experimental group

Description:

Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy with pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.

Treatment:

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

Standard Pancreaticojejunostomy

Active Comparator group

Description:

Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy using the standard surgical technique of the institution, without the application of N-Butyl-2-Cyanoacrylate or any other sealant to the pancreatic anastomosis. No placebo injection will be administered.

Treatment:

Procedure: Standard Pancreaticojejunostomy