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NCT Number: NCT07230509

Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate

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.

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Key information

Conditions

Pancreaticoduodenectomy Anastomotic Leak Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Periampullary Cancer Postoperative Complications Postoperative Pancreatic Fistula

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

Location status: Recruiting

Location contact

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: NBCA

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.

Other names: Standard PJ

Primary outcomes

  1. Incidence of postoperative pancreatic fistula

    Time frame: Up to 90 days post-surgery

    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.

Secondary outcomes

  1. Incidence of postoperative acute pancreatitis

    Time frame: 1 day post index surgery

    Altered serum amylase count on postoperative day 0 or 1

  2. Incidence of Post-Pancreatectomy Hemorrhage

    Time frame: 90 days

    As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates

  3. Incidence of intra-abdominal abscess

    Time frame: 90 days

    Collection containing gas bubbles, determining systemic signs of infection

  4. Incidence of biliary fistula

    Time frame: 90 days

    Output of bile from drains on or by post operative day 3

  5. Rate of readmission

    Time frame: 30 days after hospital discharge

    New admission within 30 days of discharge from hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: NBCA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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