Liver and GIT hospital , Minia University
Minya, Minya Governorate, 61519, Egypt
Location status: Recruiting
NCT Number: NCT07132541
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.
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Request Info18 year–75 year
All sexes
Interventional
Phase 1
Minya, Minya Governorate, 61519, Egypt
Location status: Recruiting
Postoperative pancreatic fistula (POPF) remains one of the most significant complications following pancreaticoduodenectomy (PD), with rates ranging from 10% to 30% depending on pancreatic texture and duct size. This study aims to evaluate the use of Histoacryl®, a tissue adhesive, injected into the pancreatic parenchyma to seal leaks and reinforce the anastomotic suture line, particularly in soft pancreases. The study will assess the safety, feasibility, and impact on clinically relevant POPF rates while maintaining exocrine drainage and minimizing parenchymal leakage. Thirty consecutive patients undergoing PD for pancreatic cancer, periampullary cancer, cholangiocarcinoma, or duodenal cancer will be enrolled between July 2025 and July 2026. Preoperative, intraoperative, and postoperative data will be collected and analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Reconstruction: Complete the hepaticojejunostomy and duodenojejunostomy (or gastrojejunostomy).
Other names: Histoacryl®, N-butyl-2-cyanoacrylate, Tissue adhesive injection
Time frame: 10 days
A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day.
Time frame: 1 day post index surgery
Altered serum amylase count on postoperative day 0 or 1
Time frame: 90 days
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Time frame: 90 days
Collection containing gas bubbles, determining systemic signs of infection
Time frame: 90 days
Output of bile from drains on or by post operative day 3
Time frame: 30 days after hospital discharge
New admission within 30 days of discharge from hospital
Contact information is provided by the study sponsor or research team.
Minia University
Other
Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique
Acronym: NBCA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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