NCT06756074

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 .

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

Conditions

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

Interventions

Type	Name	Description
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.
PROCEDURE	Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)	Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

Timeline

• Start date: 2025-01-15
• Primary completion: 2026-04-15
• Completion: 2026-05-15
• First posted: 2025-01-01
• Last updated: 2026-03-16

Locations

1 site across 1 country: Egypt