Reinforced Pancreaticojejunostomy With or Without glubran2

Not Applicable

Recruiting

• Conditions: Pancreatic Fistula; Pancreas Cancer; Periampullary Carcinoma; Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT06756074
• Lead Sponsor: Minia University

Brief 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 and to investigate its long term clinical outcomes.

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 .

In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent.

•After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in double blind manner (participant and investigator) in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.

Study Timeline

• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Status Verified: 2025-01
• Study First Posted: 2025-01-01
• Study Start: 2025-01-15
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-01-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the rate of Postoperative pancreatic fistula within 2 weeks after operation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liver and GIT hospital / Minia university; 🇪🇬 Minya, Egypt