A Phase 2 interventional study of Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) and Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) in Pancreatic Fistula, Pancreas Cancer and Periampullary Carcinoma, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Minia University · Phase 2, Interventional, and Treatment
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 .
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
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Procedure: Pancreaticojejunostomy without 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.
Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
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.
Time frame: within 2 weeks after operation
Post-Pancreatectomy Hemorrhage
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Time frame: 90 days
Delayed Gastric Emptying
As defined by ISGPS, grade A, B and C rates
Time frame: 90 days
Biliary fistula
Output of bile from drains on or by post operative day 3, pancreaticojejunostomy leak should be ruled out
Time frame: 90 days
Abdominal abscess
Collection \>5cm in size, containing gas bubbles, determining systemic signs of infection
Time frame: 90 days
Acute pancreatitis
Altered serum amylase count on post operative day 0 or 1
Time frame: 1 day post index surgery
Wound infection
Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention
Time frame: 90 days
Blood transfusions
Need and number of packed red blood cells transfused
Time frame: 90 days
Reoperation
Need for new surgery due to severe morbidity
Time frame: 90 days
Readmission
New admission within 30-days of discharge from hospital
Time frame: 30 days after hospital discharge
Length of Hospital Stay
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Time frame: 1 year
Mortality
Death related to surgical morbidity
Time frame: 90 days
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.
Time frame: 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
Plan to share: No
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