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RECRUITINGPhase 2INTERVENTIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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 .

Who May Be Eligible (Plain English)

Who May Qualify: - All the patients undergoing pancreaticoduodenectomy for cancer - Patients able to give their willing to sign a consent form Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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)

Locations (1)

Liver and GIT hospital / Minia university
Minya, Egypt