A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
NCT ID: NCT04867590
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2022-03-25
2027-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EndoRotor
The ENDOROTOR is a new system for the resection of superficial lesions within the digestive tract and composed of a reusable generator, a single-use probe and additional accessories.
The device is used in the resection of mucosa in the digestive tract: flat or slightly raised lesions in the digestive mucosa, or treatment of the lateral margins following a resection carried out using another technique.
Resected tissue is aspirated away through a rotating catheter: the cutting and removal of tissue as well as the collection of specimens are combined into one act.
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 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
Endoscopic treatment using the HALO® 360 or 90 system is a thermal ablation system for superficial mucosa. First and foremost, the examination includes an endoscopy to locate the upper limits of the BE and its distribution, so as to choose the most appropriate type of probe. 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.
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. 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.
Interventions
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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 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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Elodie CESBRON-METIVIER, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UH Angers
Locations
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University Hospital of Brest
Brest, , France
University Hospital of Tours
Chambray-lès-Tours, , France
University Hospital of Lille
Lille, , France
University Hospital of Limoges
Limoges, , France
Edouard Herriot Hospital
Lyon, , France
University Hospital of Nantes
Nantes, , France
University Hospital of Nice
Nice, , France
Cochin Hospital
Paris, , France
Georges Pompidou European Hospital
Paris, , France
University Hospital of Bordeaux
Pessac, , France
University Hospital of Poitiers
Poitiers, , France
University Hospital of Rennes
Rennes, , France
Countries
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Central Contacts
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Facility Contacts
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Franck CHOLET, Ph.D.
Role: primary
Driffa MOUSSATA, Ph.D.
Role: primary
Julien BRANCHE, Ph.D.
Role: primary
Jérémie JACQUES, Ph.D.
Role: primary
Mathieu PIOCHE, Ph.D.
Role: primary
Emmanuel CORON, Ph.D.
Role: primary
Geoffroy VANBIERVLIET, Ph.D.
Role: primary
Maximilien BARRET, PH.D.
Role: primary
Gabriel RAHMI, Ph.D.
Role: primary
Arthur BERGER, Ph.D.
Role: primary
Thierry BARRIOZ, Ph.D.
Role: primary
Timothée WALLENHORST, Ph.D.
Role: primary
Other Identifiers
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2020-A00975-34
Identifier Type: -
Identifier Source: org_study_id
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