Reinforced Pancreaticojejunostomy With or Without glubran2

NCT06756074 | Recruiting Phase 2 DMC

• 1 other identifier: 1350/11/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .

Conditions

Pancreatic Fistula; Pancreas Cancer; Periampullary Carcinoma; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• the rate of Postoperative pancreatic fistula within 2 weeks after operation

  Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity.

  within 2 weeks after operation

Secondary Outcomes (12)

• Post-Pancreatectomy Hemorrhage

  90 days

• Delayed Gastric Emptying

  90 days

• Biliary fistula

  90 days

• Abdominal abscess

  90 days

• Acute pancreatitis

  1 day post index surgery

Study Arms (2)

Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)

EXPERIMENTAL

Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)

Drug: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)

Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

ACTIVE COMPARATOR

Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

Procedure: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

Interventions

Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) DRUG

pancreaticojejunostomy was done with application of glubran 2: The blister pack was opened, and the sterile single-dose vial was released directly onto the operating table in a sterile environment, Draw the Glubran 2 out of the single-dose vial using a sterile syringe then put the syringe into applicator Glubran 2 was applied into anastomosis by applicator in spraying manner . Whenever possible, the area to be treated should be cleaned before application. When applied in such a minimal amount, once it had polymerized, Glubran 2 formed a thin adhesive layer. It was therefore essential not to apply more than one drop in the same point. A second layer of Glubran 2 may not be applied until the first had polymerized. Any excess product was removed using a dry swab within 5-6 seconds after application. Glubran 2 was not touched after application until the polymerization reaction is complete, as it may detach or not produce the desired effect.

Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)

Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) PROCEDURE

Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

Eligibility Criteria

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

You may qualify if:

• All the patients undergoing pancreaticoduodenectomy for cancer
• Patients able to give their informed consent

You may not qualify if:

• Unfit patients for surgery due to severe medical illness.
• Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy.
• Presence of distant metastasis .
• Patients refused to participate in the study.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital / Minia university

Minya, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula; Pancreatic Neoplasms

Interventions

glubran 2; Pancreaticojejunostomy

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Surgeons are not blinded due to the intervention's nature; care provider , assessors, and analysts are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: January 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)