RecruitingPhase 1NCT07132541

Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)

Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique


Sponsor

Minia University

Enrollment

30 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study investigates the safety and efficacy of injecting N-butyl-2-cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new surgical technique (called Saleh's technique) for connecting the remaining pancreas to the small intestine after a major pancreatic surgery called a Whipple procedure. This connection is one of the trickiest parts of the surgery, and the new technique aims to reduce the risk of dangerous leaks afterward. **You may be eligible if...** - You are having a Whipple operation (pancreaticoduodenectomy) to treat a cancerous pancreatic lesion with intent to cure - Your pancreatic tissue is soft and the main pancreatic duct is narrow (less than 3mm) - You are in adequate health to undergo surgery - You have provided written informed consent **You may NOT be eligible if...** - You have a known allergy to cyanoacrylate (a type of surgical glue) or the imaging agent Lipiodol - Your pancreas has an extremely hard or scarred texture - You have significant inflammation of the remaining pancreatic tissue - You have an active infection at the surgical site - You have uncontrolled bleeding problems - Your cancer has already spread to the liver, lymph nodes at a distance, or the lining of the abdomen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)

This procedure is integrated into the standard pancreaticoduodenectomy. Injection of Histoacryl® (n-butyl-2-cyanoacrylate) mixed with Lipiodol® (1:1 ratio) into the pancreatic parenchyma circumferentially (3, 6, 9, and 12 o'clock positions) around the main pancreatic duct (MPD) orifice, extending 5-8 mm deep and 5-10 mm laterally from the future anastomotic line, avoiding the main pancreatic duct and vessels. Total volume injected typically ranges from 0.2 ml to 0.6 ml. Follow with standard duct-to-mucosa pancreaticojejunostomy: * Tying down the posterior duct-to-mucosa sutures. * Placing and tying the anterior duct-to-mucosa sutures. * Tying down the posterior outer layer sutures. * Placing the anterior outer layer sutures. Meticulously avoid glue contact with sutures/mucosa Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).


Locations(1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07132541


Related Trials