A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus

Launched by UNIVERSITY HOSPITAL, ANGERS · Apr 27, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two treatment methods for Barrett's Esophagus, a condition that can lead to cancer. The study is looking at the effectiveness of a new device called the EndoRotor, which removes the affected tissue all at once, versus the traditional radiofrequency treatment that heats and destroys the tissue over several sessions. The goal is to see if the EndoRotor can be more effective and less costly than the current method.

To participate in this trial, patients should be adults aged 65 to 74 with Barrett's Esophagus measuring between 2 cm and 6 cm and have low to high-grade dysplasia or a specific type of early-stage cancer. Participants will need to sign a consent form before their diagnosis is confirmed. If you join the study, you can expect to receive one of the two treatments and be monitored for how well the treatment works. It’s important to note that there are specific criteria that might exclude some individuals, such as those over 85 years old or those with certain health conditions.

Gender

ALL

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.