Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate (NBCA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periampullary Cancer; Pancreas Cancer; Pancreaticoduodenectomy; Postoperative Pancreatic Fistula
• Intervention / Treatment: Drug: Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.; Procedure: Standard Pancreaticojejunostomy

Detailed Description

This randomized controlled trial aims to evaluate the efficacy of pancreatic parenchymal N-Butyl-2-Cyanoacrylate (NBCA) injection in reducing the incidence and severity of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). POPF remains a major complication of PD, leading to increased morbidity, mortality, and healthcare costs. NBCA, a tissue adhesive, has shown promise in various surgical applications due to its hemostatic and sealing properties. This study will enroll approximately 90 patients undergoing PD, randomly assigning them to either the NBCA injection group or the control group. The primary outcome will be the incidence of POPF according to the International Study Group on Pancreatic Surgery (ISGPS) definition. Secondary outcomes includes length of hospital stay, readmission rates, reoperation rates, mortality, and other postoperative complications. This trial is designed to provide high level evidence regarding the utility of NBCA in improving outcomes after PD.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Saleh K Saleh, MD; Phone Number: +2 01201765401; Email: salehkhairy@mu.edu.eg

Study Locations

• Egypt
  • Minya Governorate
    • Minya, Minya Governorate, Egypt, 61519
      • Recruiting
      • Liver and GIT hospital , Minia University
      • Contact: Saleh K Saleh, MD; Phone Number: +2 01201765401; Email: salehkhairy@mu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines.
• Soft pancreatic texture.
• Small main pancreatic duct diameter (<3 mm).
• Informed consent obtained.

Exclusion Criteria:

• Known hypersensitivity to cyanoacrylate or Lipiodol®.
• Extremely hard, fibrotic pancreas.
• Significant pancreatitis involving the pancreatic remnant.
• Active infection at the surgical site.
• Uncontrolled coagulopathy.
• Unfit patients for surgery due to severe medical illness.
• Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
• Irresectable tumors in diagnostic laparoscopy.
• Patients requiring left, central or total pancreatectomy or other palliative surgery.
• Pregnant or breastfeeding women.
• Patients with serious mental disorders.
• Patients with vascular invasion and requiring vascular resection.
• Patients refused to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.; Patients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy with pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.	Drug: Pancreatic 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).; Other Names: NBCA
Active Comparator: Standard 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.	Procedure: Standard 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.; Other Names: Standard PJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative pancreatic fistula	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.	Up to 90 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative acute pancreatitis	Altered serum amylase count on postoperative day 0 or 1	1 day post index surgery
Incidence of Post-Pancreatectomy Hemorrhage	As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates	90 days
Incidence of intra-abdominal abscess	Collection containing gas bubbles, determining systemic signs of infection	90 days
Incidence of biliary fistula	Output of bile from drains on or by post operative day 3	90 days
Rate of readmission	New admission within 30 days of discharge from hospital	30 days after hospital discharge

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Saleh K Saleh, MD, Minia University

Publications and helpful links

General Publications

• Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
• Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
• Seewald S, Sriram PV, Naga M, Fennerty MB, Boyer J, Oberti F, Soehendra N. Cyanoacrylate glue in gastric variceal bleeding. Endoscopy. 2002 Nov;34(11):926-32. doi: 10.1055/s-2002-35312. No abstract available.
• Lamsa T, Jin HT, Sand J, Nordback I. Tissue adhesives and the pancreas: biocompatibility and adhesive properties of 6 preparations. Pancreas. 2008 Apr;36(3):261-6. doi: 10.1097/MPA.0b013e31816714a2.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic surgery; Tissue adhesive; Anastomotic leak; Postoperative Pancreatic Fistula (POPF); Pancreaticoduodenectomy (PD); Pancreaticojejunostomy (PJ)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Pancreatic Neoplasms; Anastomotic Leak
• Other Study ID Numbers: 1703/09/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No