Comparing EndoRotor and Radiofrequency for Barrett's Esophagus treatment
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
This study is testing whether a new treatment called EndoRotor works better than radiofrequency for people with Barrett's esophagus and dysplasia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | radiation |
| Locations | 12 sites (Brest and 11 other locations) |
| Trial ID | NCT04867590 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with Barrett's esophagus measuring between 2 cm and 6 cm in length, exhibiting low to high grade dysplasia or superficial non-invasive adenocarcinoma.
Not a fit: Patients over 85 years old, pregnant or breastfeeding women, and those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with Barrett's esophagus, potentially reducing the risk of progression to cancer.
How similar studies have performed: While radiofrequency has been widely used with documented success, the EndoRotor technique is relatively novel and its comparative effectiveness is being evaluated in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brest and 11 other locations
- University Hospital of Brest — Brest, France (Not_yet_recruiting)
- University Hospital of Tours — Chambray-lès-Tours, France (Not_yet_recruiting)
- University Hospital of Lille — Lille, France (Not_yet_recruiting)
- University Hospital of Limoges — Limoges, France (Not_yet_recruiting)
- Edouard Herriot Hospital — Lyon, France (Recruiting)
- University Hospital of Nantes — Nantes, France (Not_yet_recruiting)
- University Hospital of Nice — Nice, France (Not_yet_recruiting)
- Cochin Hospital — Paris, France (Recruiting)
- Georges Pompidou European Hospital — Paris, France (Recruiting)
- University Hospital of Bordeaux — Pessac, France (Recruiting)
- University Hospital of Poitiers — Poitiers, France (Not_yet_recruiting)
- University Hospital of Rennes — Rennes, France (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.