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Can a new stomach surgery tame acid reflux without hiding cancer risks?

NCT ID NCT07768202

Disease control Sponsor: Victor Dib Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial tests whether a newer surgical technique, which combines sleeve gastrectomy with a rerouting of the digestive tract, can control acid reflux as well as the standard gastric bypass in adults with obesity. The new approach aims to keep the entire digestive tract visible for future endoscopic exams, unlike the bypass. Participants are randomly assigned to one of the two procedures, and the study tracks reflux symptoms, weight loss, and metabolic changes.

What this could mean

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

Active substance
sleeve gastrectomy with Roux-en-Y antrum-jejunal anastomosis (AJYR+SG) versus Roux-en-Y gastric bypass
What this could lead to
If successful, this new surgical technique could offer a way to control acid reflux as effectively as gastric bypass while keeping the digestive tract fully accessible for future cancer screening.
What could go wrong
This is a relatively small, early-stage surgical trial, and the new procedure may not control reflux as well as expected or could carry its own risks. Results may not apply to all 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

60 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Jan 2030

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 65 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: * Candidates for AJYR+SG or RYGB, aged \>18 and \<65 years * BMI ≥35 and ≤45 kg/m² * Presence of gastroesophageal reflux symptoms * Agreement to randomization between the AJYR+SG and RYGB techniques * Signed informed consent form (ICF) Exclusion Criteria: * Severe esophageal motor disorders * Crohn's disease * Advanced-stage cancer or ongoing cancer treatment * Failure to undergo the study examinations during follow-up, or withdrawal of informed consent at any time during follow-up (patients will be excluded, and their data analyzed up to the moment of dropout)

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease morbid obesity

As listed by the trial registrant

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

Gastroesophageal reflux (GERD) Obesity, morbid

Contacts and locations

Locations

  • Victor Dib Institute

    Manaus, Amazonas, 69020-210, Brazil

More trials for these conditions

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