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NCT Number: NCT04867590

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

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Dysplasia Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endorotor

Device

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 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

Device

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. 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.

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

    Time frame: 3 months after the endoscopic treatment

    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.

Secondary outcomes

  1. 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

    To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of dysplasia 3 months after the initial endoscopic treatment

  2. 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

    To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of dysplasia 12 months after the initial treatment

  3. 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

    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

  4. 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

    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

  5. 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

    To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment on eradication of Barrett esophagus 12 months after the first treatment

  6. 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

    To compare the effectiveness of endoscopic Endorotor treatment versus Radiofrequency esophageal treatment to determine the number of additional sessions carried out to achieve complete eradication at 12 months after the initial treatment

  7. 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

    After 3 months, evaluating the safety of endoscopic treatment with Endorotor, compared to the reference treatment with esophageal radiofrequency to evaluating clinical tolerance

  8. 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

    After 3 months, evaluating the safety of endoscopic treatment with Endorotor, compared to the reference treatment with esophageal radiofrequency to register the rate of serious adverse events

  9. 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

    After 3 months, evaluating the safety of endoscopic treatment with Endorotor, compared to the reference treatment with esophageal radiofrequency to evaluate the rate of esophageal stenosis

  10. 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

    Evaluate benefits of histological information obtained with Endorotor to evaluate the quality of anatomical pathology analysis of resected samples using Endorotor

  11. 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

    Determine percentage of patients for whom the analysis of resected tissue will enable the discovery of a dysplasia or adenocarcinoma, ignored on the first biopsies

  12. 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

    Determine percentage of patients for whom the analysis of resected tissue will enable a change in their follow up

  13. Evaluating the efficiency defined by the incremental cost-utility ratio

    Time frame: 12 months after the first treatment

    To assess and compare the efficiency of endoscopic EndoRotor treatment against radiofrequency treatment in the elimination of Barrett's eosophagus in term of cost per Quality Adjusted Life Years gained

  14. Evaluating the efficiency defined by the incremental cost-effectiveness ratio

    Time frame: 12 months after the first treatment

    To assess and compare the efficiency of endoscopic EndoRotor treatment against radiofrequency treatment in the elimination of Barrett's eosophagus in term of cost per rate of eradicating barrett's eosophagus

  15. Build a model to predict incomplete response for eradication of Barrett's eosophagus on the basis of each independent predictor coefficient in the multivariate regression logistic model

    Time frame: 12 months

    Build a predictive model of incomplete response to eradication of Barrett's eosophagus

Study contacts

Contact information is provided by the study sponsor or research team.

DRCI CHU Angers

CONTACT

[email protected]

+33241356329

Elodie CESBRON-METIVIER, Ph.D.

CONTACT

[email protected]

+33241353148

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study 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

Acronym: ENDOBARRETT

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Apr 30, 2021
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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