A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia (ENDOBARRETT)

  • End date
    May 21, 2026
  • participants needed
  • sponsor
    University Hospital, Angers
Updated on 21 October 2022


Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.

A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.

Condition Barrett Esophagus, Dysplasia
Treatment Radiofrequency, Endorotor
Clinical Study IdentifierNCT04867590
SponsorUniversity Hospital, Angers
Last Modified on21 October 2022


Yes No Not Sure

Inclusion Criteria

Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in the height of the longest tonguea with low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the Prague classification, with the height of the circumferential segment between 0 cm (non-circumferential segment) and 6 cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and the height of the longest tongue between 2 cm and 6 cm (M2- M6)
Patients must have signed the consent form in order to participate in the study
Patients are pre-included (signature of consent) before the histological confirmation of dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patient to be included in the study

Exclusion Criteria

Individuals over 85 years old
Women who are pregnant, breastfeeding or in labour
Individuals in detention through judicial or administrative decision
Individuals who are the subject of psychiatric treatment under duress
Individuals who are subjects of legal protection measures
Individuals who are in no state to give their consent
Individuals who do not understand French or do not know how to read
Individuals who are not part of a social security program or benefit from such a scheme
Those with active peptic and/or radiation-induced or complicated esophagitis at the time of treatment
Presence of a visible lesion that is suspected to be esophageal cancer confirmed by biopsies
Anterior resection of invasive adenocarcinoma using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with invasion of the lateral and/or deep margin, adenocarcinoma of poorly differentiated characteristics or sub-mucosal invasion > 500µm (pT1b)
All preliminary ablation treatments or dilation for esophageal stenosis
Significant esophageal stenosis: cannot be passed with a standard gastroscope
Presence of esophageal varices or portal hypertension
Anticoagulant treatment that cannot be stopped before the intervention (excluding 75 mg per day of aspirin in single-drug treatment) or any haemostasis problems that cannot be corrected
Having a contraindication regarding anaesthesia
Patients incapable of taking proton pump inhibitors (PPIs) orally
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