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

NCT07155525 | Recruiting Phase 3 DMC

• 1 other identifier: 1319/10/2024
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pancreaticoduodenectomy; Pancreaticojejunostomy; Postoperative Pancreatic Fistula; Soft Pancreas; N-Butyl-2-Cyanoacrylate; Whipple procedure; Tissue adhesive; POPF prevention

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Pancreatic Fistula (POPF).

  Percentage of patients developing postoperative pancreatic fistula as defined by International Study Group on Pancreatic Fistula (ISGPF) criteria. POPF is defined as drain output of any measurable volume of fluid on or after postoperative day 3 with amylase content greater than 3 times the upper normal serum value. Graded as A (biochemical leak), B , or C.

  30 days post-surgery.

Secondary Outcomes (6)

• Time to POPF resolution.

  90 days post-surgery.

• Postoperative complications

  30 days post-surgery

• Reoperation Rate

  90 days post-surgery.

• Length of Hospital Stay

  Up to 90 days

• Incidence of postpancreatectomy Hemorrhage

  30 days post-surgery

Study Arms (2)

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

EXPERIMENTAL

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.

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

Standard Pancreaticojejunostomy without tissue adhesive application.

ACTIVE COMPARATOR

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

Procedure: Standard(duct-to-mucosa) Pancreaticojejunostomy

Interventions

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

Also known as: Tissue Adhesive, Cyanoacrylate Glue,Glubran® 2

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

Standard(duct-to-mucosa) Pancreaticojejunostomy 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

Also known as: Standard Pancreaticojejunostomy

Standard Pancreaticojejunostomy without tissue adhesive application.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 28040257 BACKGROUND

• 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.

  PMID: 40127250 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Duodenal Neoplasms; Cholangiocarcinoma; Bile Duct Neoplasms

Interventions

Pancreaticojejunostomy; Tissue Adhesives

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

+201201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operating surgeon and patient cannot be blinded due to the nature of the intervention. However, outcome assessors, including radiologists reviewing imaging studies and physicians evaluating postoperative complications, will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): November 15, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)