A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus (ENDOBARRETT)
Barrett Esophagus, Dysplasia
About this trial
This is an interventional treatment trial for Barrett Esophagus
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 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.
Sites / Locations
- University Hospital of Brest
- University Hospital of Tours
- University Hospital of Lille
- University Hospital of Limoges
- Edouard Herriot HospitalRecruiting
- University Hospital of Nantes
- University Hospital of Nice
- Cochin HospitalRecruiting
- Georges Pompidou European HospitalRecruiting
- University Hospital of BordeauxRecruiting
- University Hospital of Poitiers
- University Hospital of Rennes
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
EndoRotor
Radiofrequency
The ENDOROTOR is a new system for the resection of superficial lesions within the digestive tract and composed of a reusable generator, a single-use probe and additional accessories. The device is used in the resection of mucosa in the digestive tract: flat or slightly raised lesions in the digestive mucosa, or treatment of the lateral margins following a resection carried out using another technique. Resected tissue is aspirated away through a rotating catheter: the cutting and removal of tissue as well as the collection of specimens are combined into one act.
Endoscopic treatment using the HALO® 360 or 90 system is a thermal ablation system for superficial mucosa. First and foremost, the examination includes an endoscopy to locate the upper limits of the BE and its distribution, so as to choose the most appropriate type of probe. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time.