Reinforced Pancreaticojejunostomy With or Without glubran2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2), Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2).
- Who it may be relevant to
- Registry conditions: Pancreatic Fistula, Pancreas Cancer, Periampullary Carcinoma, Pancreatic Ductal Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.
Overview
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
Interventions
- 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, o - Procedure Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
Primary outcome measures
- the rate of Postoperative pancreatic fistula within 2 weeks after operation [Time frame: within 2 weeks after operation]
Secondary outcome measures (12)
- Post-Pancreatectomy Hemorrhage [Time frame: 90 days]
- Delayed Gastric Emptying [Time frame: 90 days]
- Biliary fistula [Time frame: 90 days]
- Abdominal abscess [Time frame: 90 days]
- Acute pancreatitis [Time frame: 1 day post index surgery]
- Wound infection [Time frame: 90 days]
- Blood transfusions [Time frame: 90 days]
- Reoperation [Time frame: 90 days]
- Readmission [Time frame: 30 days after hospital discharge]
- Length of Hospital Stay [Time frame: 1 year]
- Mortality [Time frame: 90 days]
- Removal time of drain [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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Liver and GIT hospital / Minia university — Minya
Publications
- Saleh SK, Farahat MS, Mohamed TA, Hendy MM. Impact of reinforced pancreaticojejunostomy with or without tissue adhesive glue modified cyanoacrylate following pancreaticoduodenectomy: a randomized controlled clinical trial. World J Surg Oncol. 2026 Jun 30;24(1):268. doi: 10.1186/s12957-026-04476-3. PMID 42381068
Identifiers
NCT: NCT06756074 · 1350/11/2024