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Heat treatment may stop precancerous esophagus changes

NCT ID NCT01360541

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tested a procedure called radiofrequency ablation (using heat to remove abnormal cells) in 125 people with Barrett's esophagus and low-grade dysplasia. Participants were randomly assigned to receive the ablation or regular endoscopic monitoring. The goal was to see if ablation could reduce the presence of dysplasia after 3 years. The trial is completed, and results may help guide treatment for this condition.

What this could mean

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

Active substance
radiofrequency ablation (a procedure using heat to remove abnormal cells)
What this could lead to
If successful, this could offer a way to treat low-grade dysplasia in Barrett's esophagus and lower the risk of cancer.
What could go wrong
This is a Phase 2 trial with only 125 participants, so results may not apply to everyone. The procedure carries risks like bleeding or narrowing of the esophagus.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

125 people

The number who actually took part.

Started

Dec 2010

Finished

Dec 2018

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 80 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: * BE with certain LGD in at least one endoscopic biopsy sample * BE with maximal length of 12cm (Prague classification ≤ C12) * BE with minimal length of 1cm circumferentially or 3cm in case of a unique zone (Prague classification ≥ C1 or C0M3) * Patients aged between 18 and 80 years * Patients' consent for study enrollment * No contra-indications to general anaesthesia * Patients ability to take PPI oral medication * Patient affiliated to a social security system * No pregnancy and active contraceptions for women in age to procreate * In case of previous endoscopic mucosal resection for HGD in BE: at least one year of surveillance and 2 biopsy series with LGD without HGD Exclusion Criteria: * BE length \> 12cm or \< 1cm circumferentially (\< C1) or \< 3cm focally (\<M3) * HGD or adenocarcinoma needing a specific endoscopic or surgical treatment * Active peptic oesophagitis (Savary III or IV) * Presence of surgical staples on the area to be treated * Radiation oesophagitis of radiotherapy whose field includes the lower oesophagus * previous oesophagus cancer * previous endoscopic destruction treatment such as photodynamic therapy or plasma argon coagulation * previous Heller surgery * oesophagus stenosis * oesophagus varices * oesophagus pathology associated with sclerodermia * Severe coagulation disorders or thrombopenia * Anaesthesia contra-indications (ASA 4) * Hypersensitivity to fluorescein or any component of the fluorescein * Life expectancy \< 2 years * Disability to take PPI oral medication or follow the protocol surveillance Schedule

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Conditions

The condition(s) this trial relates to.

Barrett esophagus intraepithelial neoplasia

As listed by the trial registrant

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

Barrett oesophagus Low grade dysplasia

Contacts and locations

Locations

  • Gastroenterology and Endoscopy department, Cochin Hospital

    Paris, 75014, France