Clinical trial NCT06756074: Reinforced Pancreaticojejunostomy With or Without glubran2
Official title: Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Fistula
Pancreas Cancer
Periampullary Carcinoma
Pancreatic Ductal Adenocarcinoma
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.

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.

Primary outcomes:
measure: the rate of Postoperative pancreatic fistula within 2 weeks after operation
timeFrame: within 2 weeks after operation
Secondary outcomes:
measure: Post-Pancreatectomy Hemorrhage
timeFrame: 90 days
measure: Delayed Gastric Emptying
timeFrame: 90 days
measure: Biliary fistula
timeFrame: 90 days
measure: Abdominal abscess
timeFrame: 90 days
measure: Acute pancreatitis
timeFrame: 1 day post index surgery
measure: Wound infection
timeFrame: 90 days
measure: Blood transfusions
timeFrame: 90 days
measure: Reoperation
timeFrame: 90 days
measure: Readmission
timeFrame: 30 days after hospital discharge
measure: Length of Hospital Stay
timeFrame: 1 year
measure: Mortality
timeFrame: 90 days
measure: Removal time of drain
timeFrame: 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
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Liver and GIT hospital / Minia university
Study officials:
affiliation: Minia University
name: Saleh K Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References: