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PancreaticoduodenectomyPhase 1NBCANCT07132541

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

A Phase 1 study testing Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®) 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 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. 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®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
25 Aug 2025to 25 Dec 2026
Phase
Phase 1
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, +201201765401 ext. +2, salehkhairy@mu.edu.eg

    Recruiting

Other trials in Egypt

About this study

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

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.

Read the detailed description

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.

Being tested
Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)
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®)Drug

    Also called Histoacryl®, N-butyl-2-cyanoacrylate, Tissue adhesive injection

    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).

Study groups in NCT07132541
Study groupRoleWhat they receive
N-butyl-2-cyanoacrylate (Histoacryl® )Injection Group.ExperimentalPatients in this group will receive pancreatic parenchymal injection of N-butyl-2-cyanoacrylate during pancreaticoduodenectomy.
Receives: Drug: Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®)

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: 10 days

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 posted20 Aug 2025
  2. Study start25 Aug 2025
  3. Primary completion25 Nov 2026 (estimated)
  4. Study completion25 Dec 2026 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients receiving pancreatic parenchymal injection of N-butyl-2-cyanoacrylate (Histoacryl®) during pancreaticojejunostomy
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07132541
Sponsor's protocol ID
1606/07/2025
Acronym
NBCA
Status last verified
Sep 2026
First submitted
13 Aug 2025
Last updated
11 Sep 2026
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 1 study testing Pancreatic parenchymal injection of N-butyl-2-cyanoacrylate(Histoacryl®) 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 11 Sep 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: 10 days). 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 NCT07132541, 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 11 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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