RecruitingPhase 2NCT07230509

Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate

Efficacy of Pancreatic Parenchymal N-Butyl-2-Cyanoacrylate Injection in Pancreaticojejunostomy After Pancreaticoduodenectomy: A Randomized Controlled Trial


Sponsor

Minia University

Enrollment

90 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled trial 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 surgical study is testing whether injecting a medical glue (N-butyl-2-cyanoacrylate) into the pancreas during surgery can reduce the risk of dangerous leaks after a Whipple procedure — an operation to remove part of the pancreas. Pancreatic leaks are a major complication of this surgery. **You may be eligible if...** - You are scheduled for a Whipple procedure (pancreaticoduodenectomy) to treat a cancer or tumor - Your pancreas has a soft texture (a risk factor for leaks) - Your main pancreatic duct is small (less than 3mm wide) - You have given informed consent **You may NOT be eligible if...** - You have a known allergy to cyanoacrylate glue or Lipiodol (an iodized oil) - Your pancreas is already hard and fibrotic - You have significant pancreatitis in the remaining pancreas - You have an active infection at the surgical site - You have uncontrolled medical conditions that make surgery unsafe 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.

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Interventions

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

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).

PROCEDUREStandard Pancreaticojejunostomy

Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy using the standard surgical technique of the institution, without the application of N-Butyl-2-Cyanoacrylate or any other sealant to the pancreatic anastomosis. No placebo injection will be administered.


Locations(1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

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NCT07230509


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