Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07132541

Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

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]

+201201765401 ext. +2

About this study

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.

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®)

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: Histoacryl®, N-butyl-2-cyanoacrylate, Tissue adhesive injection

Primary outcomes

  1. Incidence of postoperative pancreatic fistula

    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.

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

Pancreatic Parenchymal Injection of N-Butyl-2-Cyanoacrylate for Pancreaticojejunostomy After Pancreaticoduodenectomy: A Novel Technique

Acronym: NBCA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Sep 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.

Published trials that share one or more normalized conditions with this study.