A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus

Last updated: April 8, 2024
Sponsor: University Hospital, Angers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Precancerous Condition

Esophageal Disorders

Treatment

Radiofrequency

Endorotor

Clinical Study ID

NCT04867590
2020-A00975-34
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in theheight of the longest tonguea with low to high grade dysplasia that is histologicallyproven or with a superficial non-invasive adenocarcinoma that has been resected a Thetotal height of the BE is evaluated according to the Prague classification, with theheight of the circumferential segment between 0 cm (non-circumferential segment) and 6cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and theheight 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 confirmationof dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patientto be included in the study.

Exclusion

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 ascheme
  • Those with active peptic and/or radiation-induced or complicated esophagitis at thetime of treatment
  • Presence of a visible lesion that is suspected to be esophageal cancer confirmed bybiopsies
  • Anterior resection of invasive adenocarcinoma using endoscopic mucosal resection (EMR)or endoscopic submucosal dissection (ESD) with invasion of the lateral and/or deepmargin, adenocarcinoma of poorly differentiated characteristics or sub-mucosalinvasion > 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 100mg maximum per day of aspirin in single-drug treatment) or any haemostasis problemsthat cannot be corrected
  • Having a contraindication regarding anaesthesia
  • Patients incapable of taking proton pump inhibitors (PPIs) orally.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Radiofrequency
Phase:
Study Start date:
March 25, 2022
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • University Hospital of Brest

    Brest,
    France

    Site Not Available

  • University Hospital of Tours

    Chambray-lès-Tours,
    France

    Site Not Available

  • University Hospital of Lille

    Lille,
    France

    Site Not Available

  • University Hospital of Limoges

    Limoges,
    France

    Site Not Available

  • Edouard Herriot Hospital

    Lyon,
    France

    Active - Recruiting

  • University Hospital of Nantes

    Nantes,
    France

    Site Not Available

  • University Hospital of Nice

    Nice,
    France

    Site Not Available

  • Cochin Hospital

    Paris,
    France

    Active - Recruiting

  • Georges Pompidou European Hospital

    Paris,
    France

    Active - Recruiting

  • University Hospital of Bordeaux

    Pessac,
    France

    Active - Recruiting

  • University Hospital of Poitiers

    Poitiers,
    France

    Site Not Available

  • University Hospital of Rennes

    Rennes,
    France

    Site Not Available

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