Comparing EndoRotor and Radiofrequency for Barrett's Esophagus treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of two treatment methods, EndoRotor and radiofrequency, for patients with Barrett's esophagus and dysplasia. Barrett's esophagus is a condition that can lead to precancerous changes, and current treatments primarily use thermal destruction techniques. The study will evaluate the outcomes of these two approaches, focusing on the eradication of dysplasia and the potential for histological analysis post-treatment. Patients will be monitored for their response to treatment and any progression of the disease.

Why it matters

Who can join: the full rules

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 100 mg maximum 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.

Where it's running

• University Hospital of Besançon
  Besançon, France Recruiting
• University Hospital of Tours
  Chambray-lès-Tours, France Recruiting
• University Hospital of Dijon
  Dijon, France Recruiting
• University Hospital of Lille
  Lille, France Recruiting
• University Hospital of Limoges
  Limoges, France Recruiting
• Edouard Herriot Hospital
  Lyon, France Recruiting

Study contacts

• Principal investigator: Elodie CESBRON-METIVIER, Ph.D. — UH Angers
• Study coordinator: Elodie CESBRON-METIVIER, Ph.D.
• Email: elcesbronmetivier@chu-angers.fr
• Phone: +33241353148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.