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PancreaticoduodenectomyPhase 2NBCANCT07230509

Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate

A Phase 2 study testing Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group. and Standard Pancreaticojejunostomy in people with Pancreaticoduodenectomy and Postoperative Pancreatic Fistula, run by Minia University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group. and Standard Pancreaticojejunostomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Dec 2025to 20 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saleh K Saleh, MD contact

01201765401 ext. +2

salehkhairy@mu.edu.eg

Egypt1 site, 1 recruiting

  • Liver and GIT hospital , Minia University

    Minya, Minya Governorate, 61519

    Saleh K Saleh, MD, 01201765401 ext. +2, salehkhairy@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group., Standard Pancreaticojejunostomy
Keywords
Pancreatic surgery, Anastomotic leak, Tissue adhesive, Postoperative Pancreatic Fistula (POPF), Pancreaticoduodenectomy (PD), Pancreaticojejunostomy (PJ)
Medical subject headings
Pancreatic Neoplasms, Anastomotic Leak

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called NBCA

    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).

  • Standard PancreaticojejunostomyProcedure or surgery

    Also called Standard PJ

    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.

Study groups in NCT07230509
Study groupRoleWhat they receive
N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.ExperimentalPatients randomized to this group will undergo pancreaticoduodenectomy and pancreaticojejunostomy with pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.
Receives: Drug: Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group.
Standard PancreaticojejunostomyActive comparatorPatients 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.
Receives: Procedure: Standard Pancreaticojejunostomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 90 days post-surgery

Secondary outcomes (5)

  1. Incidence of postoperative acute pancreatitis

    Altered serum amylase count on postoperative day 0 or 1

    Measured: 1 day post index surgery

  2. Incidence of Post-Pancreatectomy Hemorrhage

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

    Measured: 90 days

  3. Incidence of intra-abdominal abscess

    Collection containing gas bubbles, determining systemic signs of infection

    Measured: 90 days

  4. Incidence of biliary fistula

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

    Measured: 90 days

  5. Rate of readmission

    New admission within 30 days of discharge from hospital

    Measured: 30 days after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start1 Dec 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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®).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230509
Sponsor's protocol ID
1703/09/2025
Acronym
NBCA
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28040257

  • 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.

    PubMed 23122535

  • 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.

    PubMed 12430080

  • 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.

    PubMed 18362839

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pancreatic parenchymal injection of N-butyl-2- cyanoacrylate(Histoacryl®)Injection Group. and Standard Pancreaticojejunostomy in people with Pancreaticoduodenectomy and Postoperative Pancreatic Fistula, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Saleh K Saleh, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative pancreatic fistula (time frame: Up to 90 days post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07230509, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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