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Special stitches aim to stop pancreatic leaks after major surgery

NCT ID NCT07318493

Disease control Sponsor: The Cleveland Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using antiseptic-coated sutures instead of standard ones can lower the chance of a pancreatic fistula (a leak of digestive fluid) after a Whipple procedure. About 436 adults scheduled for this surgery will be randomly assigned to receive either the coated or standard stitches. The main goal is to see if the coated sutures reduce fistula rates within 90 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
triclosan/antiseptic-coated suture
What this could lead to
If it works, this could reduce a common and serious complication after Whipple surgery, potentially shortening hospital stays and improving recovery.
What could go wrong
This is a relatively small, early-stage trial testing a device modification. The benefit may be small or not statistically significant, and results may not apply to all surgical settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 436 people

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

Started

Jan 2026

Expected to finish

Feb 2031

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 years and older

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: * Subjects must be undergoing a scheduled pancreatoduodenectomy. * Age ≥18 years. * Subjects must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients \< 18 years old * Patients who are pregnant * Patients with history of previous pancreatic surgery * Patients who are unable to provide informed consent

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As listed by the trial registrant

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

Pancreatoduodenectomy Whipple procedure

How to take part

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

  1. The places running it

    3 sites. 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

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Akron

    RECRUITING

    Akron, Ohio, 44307, United States

  • Cleveland Clinic Fairview Hospital

    RECRUITING

    Fairview, Ohio, 44111, United States

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