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Can a simple patch make stomach surgery safer?

NCT ID NCT06464978

Disease control Sponsor: Nanchong Central Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using a reinforcement patch on surgical staplers can lower the risk of leaks and other complications after stomach cancer surgery. About 382 patients will be randomly assigned to receive either the reinforced stapler or a standard stapler during their operation. The main goal is to see if the patch reduces the rate of anastomotic leakage 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
stapler reinforcement patch (a device used during surgery)
What this could lead to
If it works, this could reduce serious complications like leaks after stomach surgery, making recovery safer for gastric cancer patients.
What could go wrong
This is a mid-sized trial testing a device, not a new drug. The patch may not lower complication rates significantly, and results may not apply to all hospitals or patients.

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 382 people

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

Started

May 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 85 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: * Age between 18 and 85 years. * Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy. * ECOG performance status of 0 or 1. * ASA (American Society of Anesthesiologists) classification of I-III. * Voluntary signed informed consent from the participant or their legal representative. Exclusion Criteria: * Evidence of potential distant metastasis found preoperatively. * History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy. * Significant contraindications for surgery (e.g., severe liver or kidney dysfunction). * Participation in any other clinical trial within the last 6 months. * Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak gastric cancer gastric neoplasm Postoperative Complications

As listed by the trial registrant

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

Anastomotic leakage Gastric cancer Gastrostomy Postoperative complications

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

  • Yunhong Tian

    RECRUITING

    Nanchong, Sichuan, 637000, China

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