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

Official title

A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia

Overview

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.

Interventions

• Device Endorotor
  The 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
• Device Radiofrequency
  Endoscopic 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. T

Primary outcome measures

• 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 [Time frame: 3 months after the endoscopic treatment]

Secondary outcome measures (12)

• Effectiveness assessment defined by the absence of dysplasia on all systematic esophageal biopsies confirmed by an anatomical pathological reading on site [Time frame: 3 months after the initial endoscopic treatment]
• Effectiveness assessment defined by the absence of dysplasia on all systematic oesophageal biopsies confirmed by an anatomical pathological reading on site [Time frame: 12 months after the initial treatment]
• 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 [Time frame: 3 months after the initial endoscopic treatment]
• 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 [Time frame: 12 months after the initial treatment]
• Effectiveness assessment defined by the rate of eradicating Barrett esophagus 12 months after the initial endoscopic treatment which is confirmed by the absence of Barrett esophagus lesions on biopsies [Time frame: 12 months after the first treatment]
• Effectiveness assessment defined by the number of additional treatment sessions carried out using radiofrequency to achieve complete eradication of Barrett esophagus at 12 months, after initial endoscopic treatment [Time frame: 12 months after the initial treatment]
• Safety assessment defined by the discomfort score is recorded in a log over as well as dysphagia score and pain evaluation in first 30 days following the initial procedure and during the clinical evaluating [Time frame: 3 months after the initial endoscopic treatment]
• Safety assessment defined by the serious adverse events after treatment and then at day 2, day 15, day 30 and 3 months after the initial endoscopic treatment are classed in four levels of severity based on the level of hospitalization, in accordance with [Time frame: 3 months after the initial treatment]
• Safety assessment defined by esophageal stenosis that cannot be passed by a standard gastroscope of 10 mm in diameter. [Time frame: 3 months after the initial treatment]
• Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the quality of the anatomical pathological analysis for the samples taken during treatment is determined through a centralised readin [Time frame: 12 months after the first treatment]
• Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the percentage of patients for whom the analyses of resected tissue enable the discovery of a dysplasia or adenocarcinoma [Time frame: 12 months after the first treatment]
• Evaluating the benefit of anatomo pathological analysis of resected tissue after treatment using ENDOROTOR defined by the percentage of patients for whom the analyses of resected tissue enable a change in the follow-up plan [Time frame: 12 months after the first treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 17 centers

• University Hospital of Besançon — Besançon
• University Hospital of Brest — Brest
• University Hospital of Tours — Chambray-lès-Tours
• University Hospital of Dijon — Dijon
• University Hospital of Lille — Lille
• University Hospital of Limoges — Limoges
• Edouard Herriot Hospital — Lyon
• University Hospital of Montpellier — Montpellier
• … and 9 more centers

Identifiers

NCT: NCT04867590 · 2020-A00975-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗