A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Endorotor
DeviceThe treatment itself is preceded by a sub-mucosa saline and adrenalin solution injection administered by an endoscopic sclerotherapy needle lifting the submucosa and thus reducing the risk of perforation and hemorrhage. The interventional tool is then applied tangentially to be brought into contact with the lifted mucosa, visual monitored by endoscope. The aspiration and sectioning system is activated by use of a pedal and a generator specially made for the system, used in every procedure. The entire surface area of the targeted mucosa must be covered by the probe. The residual tissue is then removed via the aspiration system and caught by a filter. The specimens are then easily retrievable at the end of the procedure and can be stored in formalin fixing solution for histological analysis.
Radiofrequency
DeviceEndoscopic treatment using the HALO® 360 or 90 system is a thermal method for destroying the superficial mucosa. 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. For circumferential BEs, a single-use 360 Express® probe is used to make it possible to size the diameter of the esophagus and the treatment used. The length of the treatment area is 5 cm and several points of impact can be achieved by overlapping the catheter at two consecutive heights, with the zone spanned measuring one centimeter, in order to cover the entire pathological area requiring treatment. For non-circumferential lesions a "palette" applicator is used in a variety of sizes, and in this context no sizing of the esophagus is required.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: EndoRotorExperimental treatment 1 intervention
Group B: RadiofrequencyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The rate of full eradication of Barrett esophagus (metaplasia), which is defined by the absence of residual Barrett esophagus in the check-up endocopy after 3 months
To evaluate, 3 months after the first endoscopic treatment, the effectiveness of Endorotor treatment versus Radiofrequency in the elimination of Barrett esophagus complicated with dysplasia or adenocarcinoma.
Time frame
3 months after the endoscopic treatmentSecondary outcomes
1
Effectiveness assessment defined by the absence of dysplasia on all systematic esophageal biopsies confirmed by an anatomical pathological reading on site
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of dysplasia 3 months after the initial endoscopic treatment
Time frame
3 months after the initial endoscopic treatment2
Effectiveness assessment defined by the absence of dysplasia on all systematic oesophageal biopsies confirmed by an anatomical pathological reading on site
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of dysplasia 12 months after the initial treatment
Time frame
12 months after the initial treatment3
Effectiveness assessment defined by the area regression of Barrett esophagus between the pre-treatment evaluation and the follow-up at 3 months is evaluated using a visual endoscopic scale of the area Barrett esophagus regression and video analysis
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on the area of Barrett esophagus regression 3 months after the initial treatment
Time frame
3 months after the initial endoscopic treatment4
Effectiveness assessment defined by the area regression of Barrett esophagus between the pre-treatment evaluation and the follow-up at 12 months is evaluated using a visual endoscopic scale of the area Barrett esophagus regression and video analysis
To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on the area of Barrett esophagus regression 12 months after the initial treatment
Time frame
12 months after the initial treatmentSponsors and contacts
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Source ClinicalTrials.gov