Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate

NCT07230509 | Recruiting Phase 2 DMC

• 1 other identifier: 1703/09/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreaticoduodenectomy; Postoperative Pancreatic Fistula; Pancreas Cancer; Periampullary Cancer

Keywords

Pancreatic surgery; Anastomotic leak; Tissue adhesive; Postoperative Pancreatic Fistula (POPF); Pancreaticoduodenectomy (PD); Pancreaticojejunostomy (PJ)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of postoperative acute pancreatitis

  1 day post index surgery

• Incidence of Post-Pancreatectomy Hemorrhage

  90 days

• Incidence of intra-abdominal abscess

  90 days

• Incidence of biliary fistula

  90 days

• Rate of readmission

  30 days after hospital discharge

Study Arms (2)

N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.

EXPERIMENTAL

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.

Standard Pancreaticojejunostomy

ACTIVE COMPARATOR

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

Interventions

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

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).

Also known as: NBCA

N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.

Standard Pancreaticojejunostomy PROCEDURE

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.

Also known as: Standard PJ

Standard Pancreaticojejunostomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 28040257 BACKGROUND

• 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.

  PMID: 23122535 BACKGROUND

• 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.

  PMID: 12430080 BACKGROUND

• 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.

  PMID: 18362839 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Patients randomized to the groups will receive a standardized volume (e.g., 0.5 mL of a 1:1 mixture of NBCA and Lipiodol) of N-Butyl-2-Cyanoacrylate injected into the pancreatic parenchyma during pancreaticojejunostomy. The injection will be performed using a fine-gauge needle at multiple points to ensure even distribution. The specific NBCA product will be a commercially available, cyanoacrylate adhesive (e.g., Histoacryl®).

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)