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

NCT ID: NCT07155525

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-11-15

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

• Standard duct-to-mucosa pancreaticojejunostomy performed
• Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site
• Adhesive applied circumferentially around the pancreaticojejunal anastomosis
• Allow 2-3 minutes for polymerization before proceeding
• Standard placement of peritoneal drains

Standard Pancreaticojejunostomy without tissue adhesive application.

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

Group Type: ACTIVE_COMPARATOR

Standard(duct-to-mucosa) Pancreaticojejunostomy

Intervention Type: PROCEDURE

• Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.
• Standard placement of peritoneal drains
• All other aspects of surgical care identical to experimental arm

Interventions

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

• Standard duct-to-mucosa pancreaticojejunostomy performed
• Application of 0.5-1.0 mL modified N-butyl-2-cyanoacrylate around the anastomotic site
• Adhesive applied circumferentially around the pancreaticojejunal anastomosis
• Allow 2-3 minutes for polymerization before proceeding
• Standard placement of peritoneal drains

Intervention Type: DRUG

Standard(duct-to-mucosa) Pancreaticojejunostomy

• Patients undergo duct-to-mucosa pancreaticojejunostomy without additional adhesive following pancreaticoduodenectomy.
• Standard placement of peritoneal drains
• All other aspects of surgical care identical to experimental arm

Intervention Type: PROCEDURE

Other Intervention Names

Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2; Standard Pancreaticojejunostomy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

salehkhairy@mu.edu.eg

+201201765401 ext. +2

Facility Contacts

Saleh K Saleh, MD

Role: primary

salehkhairy@mu.edu.eg

+201201765401 ext. +2

References

Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

Reference Type: BACKGROUND

PMID: 28040257 (View on PubMed)

Gaspar AF, Kemp R, Sankarankutty AK, Lopes Junior JR, Filho JAF, Avezum VAPAF, de Assis Mota G, Nunes AA, Dos Santos JS. Influence on Postoperative Results and Cost-effectiveness of Using Cyanoacrylate Glue for Pancreaticojejunal Anastomosis After Duodenopancreatectomy. Pancreas. 2025 Aug 1;54(7):e610-e617. doi: 10.1097/MPA.0000000000002479.

Reference Type: BACKGROUND

PMID: 40127250 (View on PubMed)

Other Identifiers

1319/10/2024

Identifier Type: -

Identifier Source: org_study_id