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Surgical glue may seal pancreas after cancer surgery, cutting dangerous leaks

NCT ID NCT07155525

Disease control Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 trial tests whether adding a surgical glue called N-butyl-2-cyanoacrylate to standard pancreatic surgery can prevent postoperative pancreatic fistula—a common and serious leak of digestive fluids. About 194 patients with soft pancreas tissue undergoing tumor removal will be randomly assigned to receive either standard surgery or surgery plus glue. The main goal is to see if the glue reduces leak rates within 30 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N-butyl-2-cyanoacrylate (surgical glue, brand name Glubran® 2)
What this could lead to
If it works, this could reduce the risk of pancreatic leaks after surgery, leading to fewer complications and shorter hospital stays for patients with soft pancreas tissue.
What could go wrong
This is a single-center trial with 194 patients, so results may not apply broadly. The glue could cause inflammation or fail to prevent leaks, and surgery risks like infection or bleeding remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 194 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients scheduled for elective pancreaticoduodenectomy for malignant lesions. * Intraoperative confirmation of soft pancreatic texture (by surgeon palpation; friable, non-fibrotic pancreas). * Age 18-75 years . * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Adequate organ function defined as: Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,500/μL Platelet count ≥ 100,000/μL Total bilirubin ≤ 3 times upper limit of normal Alanine transaminase (ALT) /Alanine transaminase (ALT)( ≤ 5 times upper limit of normal Serum creatinine ≤ 1.5 times upper limit of normal * Informed consent provided. * Willingness to comply with study procedures and follow-up requirements. Exclusion Criteria: * Hard pancreatic texture (intraoperative surgeon assessment). * Emergency surgery. * Previous pancreatic surgery or pancreatic anastomosis. * Intraoperative identification of unresectable disease * Known allergy to cyanoacrylate or components. * Pregnancy or lactation. * Active infection or sepsis. * Inability to comply with follow-up.

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Conditions

The condition(s) this trial relates to.

bile duct cancer bile duct neoplasm carcinoma of duodenum cholangiocarcinoma duodenum cancer malignant pancreatic neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm periampullary adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bile duct cancer Cholangiocarcinoma Duodenal cancer Pancreatic cancer Pancreatic ductal adenocarcinoma Pancreatic head mass Periampullary cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Liver and GIT hospital , Minia University

    RECRUITING

    Minya, Minya Governorate, 61519, Egypt

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