NCT04867590 A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
| NCT ID | NCT04867590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Barrett Esophagus |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-03-25 |
| Primary Completion | 2031-07-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2022-03-25 with a primary completion date of 2031-07-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Elodie CESBRON-METIVIER, Ph.D.
PRINCIPAL INVESTIGATOR
UH Angers
Frequently Asked Questions
Who can join the NCT04867590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Barrett Esophagus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04867590 currently recruiting?
Yes, NCT04867590 is actively recruiting participants. Contact the research team at elcesbronmetivier@chu-angers.fr for enrollment information.
Where is the NCT04867590 trial being conducted?
This trial is being conducted at Besançon, France, Brest, France, Chambray-lès-Tours, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT04867590 clinical trial?
NCT04867590 is sponsored by University Hospital, Angers. The principal investigator is Elodie CESBRON-METIVIER, Ph.D. at UH Angers. The trial plans to enroll 140 participants.