Status:
RECRUITING
A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
Lead Sponsor:
University Hospital, Angers
Conditions:
Barrett Esophagus
Dysplasia
Eligibility:
All Genders
18+ years
Phase:
NA
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%...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04867590
Start Date
March 25 2022
End Date
May 1 2027
Last Update
April 9 2024
Active Locations (12)
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1
University Hospital of Brest
Brest, France
2
University Hospital of Tours
Chambray-lès-Tours, France
3
University Hospital of Lille
Lille, France
4
University Hospital of Limoges
Limoges, France