Reinforced Pancreaticojejunostomy With or Without glubran2

Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.

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 .

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Fistula; Pancreatic Ductal Adenocarcinoma; Pancreas Cancer; Periampullary Carcinoma
• Intervention / Treatment: Procedure: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2); Drug: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)

Detailed Description

Tissue adhesives have gained popularity in various fields of surgical practice. There are various types of tissue adhesives, each with their own adhesive mechanisms and uses. Basically, a tissue adhesive forms bonds with its substrate, ensuring sufficient adhesion. These bonds can either be chemical, of which covalent bonds are the strongest, or physical, including hydrogen bonds or van der Waals forces. Furthermore, the total strength of the glue bond depends on the balance between interaction within the tissue adhesive (cohesion) and between the tissue adhesive-substrate interface (adhesion). Tissue adhesives can either be glues, intended to independently connect various structures (i.e., wound edges), or sealants, used to cover and protect an anastomosis .

Except for external use, tissue adhesives can also be used intracorporeally. Various tissue adhesives are being used in cardiovascular surgery, plastic surgery, and, increasingly, surgery of the GI tract .

Tissue adhesives are promising tools for wound closure. They distribute forces throughout the wound more evenly and noninvasively than sutures and staples, are strong and flexible, and do not interfere with the wound-healing process. Also, the technique of tissue adhesive application to the wound is easy and standardizable, resulting in less variation in technique between surgeons .

By using tissue adhesives as sealants of GI anastomosis, enhancing standard anastomotic techniques. Numerous research projects have been undertaken to assess the applicability of available tissue adhesives in GI surgery; however, no recent literature provides the surgical community with an up-to-date overview of the progress in this field .

•After being informed about the study and potential risks, all patients giving written consent. Eligible patients were randomly assigned in a 1:1 ratio to either the Glubran®2 group (Group A) or the Control group (Group B) using a computer-generated randomization sequence with permuted blocks of 4 and 6. Allocation concealment was ensured using serially numbered, opaque, sealed envelopes prepared by an independent statistician. Each envelope was opened by the scrub nurse or anesthesiologist immediately after the completion of the pancreaticojejunostomy anastomosis, before final hemostasis and abdominal closure

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Saleh K Saleh, MD; Phone Number: +2 01201765401; Email: salehkhairy@mu.edu.eg

Study Locations

• Egypt
  • Minya, Egypt, 61519
    • Recruiting
    • Liver and GIT hospital / Minia university
    • Contact: Saleh K Saleh, MD; Phone Number: +2 01201765401; Email: salehkhairy@mu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)
Experimental: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)	Drug: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission	1 year
Mortality	Death related to surgical morbidity	90 days
Post-Pancreatectomy Hemorrhage	As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates	90 days
Delayed Gastric Emptying	As defined by ISGPS, grade A, B and C rates	90 days
Abdominal abscess	Collection >5cm in size, containing gas bubbles, determining systemic signs of infection	90 days
Wound infection	Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention	90 days
Blood transfusions	Need and number of packed red blood cells transfused	90 days
Reoperation	Need for new surgery due to severe morbidity	90 days
Readmission	New admission within 30-days of discharge from hospital	30 days after hospital discharge
Biliary fistula	Output of bile from drains on or by post operative day 3, pancreaticojejunostomy leak should be ruled out	90 days
Acute pancreatitis	Altered serum amylase count on post operative day 0 or 1	1 day post index surgery
Removal time of drain	The timing of removal of the drain tube is determined based on the time of removal of the last drain tube. The removal of the drain tube is assessed at the discretion of the surgeon.	From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Saleh K Saleh, MD, Minia university

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): January 1, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Signs and Symptoms; Pancreatic Neoplasms; Pancreatic Fistula; Surgical Procedures, Operative; Digestive System Surgical Procedures; Anastomosis, Surgical; Pancreaticojejunostomy; glubran 2
• Other Study ID Numbers: 1350/11/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No