Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas (NBCA-MS)

Minia University

Status and phase: Enrolling; Phase 3

Conditions: Bile Duct Cancer; Periampullary Cancer; Pancreatic Head Mass; Cholangiocarcinoma; Pancreatic Ductal Adenocarcinoma; Duodenal Cancer; Pancreatic Cancer

Treatments: Drug: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2); Procedure: Standard(duct-to-mucosa) Pancreaticojejunostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07155525

1319/10/2024

Details and patient eligibility

About

This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.

Full description

Postoperative pancreatic fistula (POPF) remains the most common and serious complication following pancreaticoduodenectomy, with incidence rates reaching up to 56.7% in patients with soft pancreatic texture. The soft pancreatic parenchyma is particularly vulnerable to anastomotic breakdown due to its friable nature and difficulty in achieving secure suturing.

N-butyl-2-cyanoacrylate is a biodegradable tissue adhesive that polymerizes rapidly upon contact with hydroxide ions in tissue fluids, forming a strong, flexible bond. The application of modified N-butyl-2-cyanoacrylate to pancreaticoenteric anastomoses may reduce the incidence of POPF by providing additional mechanical reinforcement and sealing of minor leaks.

This is a phase III, single-center, prospective, randomized controlled trial with parallel groups. Eligible patients will undergo intraoperative assessment of pancreatic texture (soft confirmed by surgeon's palpation). Randomization will occur intraoperatively after resection but before reconstruction, using computer-generated blocks.

This study aims to evaluate whether the application of modified N-butyl-2-cyanoacrylate (Glubran® 2) during pancreaticojejunostomy can significantly reduce the incidence of POPF in patients with soft pancreatic texture undergoing pancreaticoduodenectomy. Patients will be randomized to receive either standard pancreaticojejunostomy (control group) or pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate application (intervention group).

The intervention group will receive 1-2 mL of modified N-butyl-2-cyanoacrylate applied topically to the pancreatic stump and anastomosis site during pancreaticojejunostomy. The control group will receive standard duct-to-mucosa pancreaticojejunostomy without adhesive. All patients will receive standardized perioperative care, including prophylactic antibiotics and drain management per ISGPF guidelines.

Follow-up will include daily amylase measurements in drains (days 1,3,5), CT imaging if POPF suspected.

Enrollment: 194 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective pancreaticoduodenectomy for malignant lesions.
• Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas).
• Age 18-75 years .
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate organ function defined as:

Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal

• Informed consent provided.
• Willingness to comply with study procedures and follow-up requirements.

Exclusion criteria

• Hard pancreatic texture (intraoperative surgeon assessment).
• Emergency surgery.
• Previous pancreatic surgery or pancreatic anastomosis.
• Intraoperative identification of unresectable disease
• Known allergy to cyanoacrylate or components.
• Pregnancy or lactation.
• Active infection or sepsis.
• Inability to comply with follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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194 participants in 2 patient groups

Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)

Experimental group

Description:

Patients undergo standard duct-to-mucosa pancreaticojejunostomy with topical application of 1-2 mL modified N-butyl-2-cyanoacrylate to the anastomotic site and surrounding pancreatic parenchyma.

Treatment:

Drug: Pancreaticojejunostomy with Modified N-Butyl-2-Cyanoacrylate (Glubran® 2)

Standard Pancreaticojejunostomy without tissue adhesive application.

Active Comparator group

Description:

Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.

Treatment:

Procedure: Standard(duct-to-mucosa) Pancreaticojejunostomy