2025-01-15
2026-01-15
2026-02-15
100
NCT06756074
Minia University
Minia University
INTERVENTIONAL
Reinforced Pancreaticojejunostomy With or Without glubran2
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-24 | N/A | 2025-01-17 |
2024-12-24 | N/A | 2025-01-22 |
2025-01-01 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2) | PROCEDURE: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)
|
| ACTIVE_COMPARATOR: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2) | PROCEDURE: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | within 2 weeks after operation |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Post-Pancreatectomy Hemorrhage | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates | 90 days |
| Delayed Gastric Emptying | As defined by ISGPS, grade A, B and C rates | 90 days |
| Biliary fistula | Output of bile from drains on or by post operative day 3, pancreaticojejunostomy leak should be ruled out | 90 days |
| Abdominal abscess | Collection >5cm in size, containing gas bubbles, determining systemic signs of infection | 90 days |
| Acute pancreatitis | Altered serum amylase count on post operative day 0 or 1 | 1 day post index surgery |
| Wound infection | Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention | 90 days |
| Blood transfusions | Need and number of packed red blood cells transfused | 90 days |
| Reoperation | Need for new surgery due to severe morbidity | 90 days |
| Readmission | New admission within 30-days of discharge from hospital | 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 | 1 year |
| Mortality | Death related to surgical morbidity | 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. | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Saleh K Saleh, MD Phone Number: 01201765401 Email: salehkhairy@mu.edu.eg |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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