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

NCT04867590 | Recruiting

• 1 other identifier: 2020-A00975-34
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Barrett Esophagus; Dysplasia

Outcome Measures

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.

  3 months after the endoscopic treatment

Secondary Outcomes (15)

• Effectiveness assessment defined by the absence of dysplasia on all systematic esophageal biopsies confirmed by a double anatomical pathological reading on site, with centralised re-reading in the event of disagreement

  3 months after the initial endoscopic treatment

• Effectiveness assessment defined by the absence of dysplasia on all systematic oesophageal biopsies confirmed by a double anatomical pathological reading on site, with centralised re-reading in the event of disagreement

  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

  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

  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

  12 months after the first treatment

Study Arms (2)

EndoRotor

EXPERIMENTAL

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.

Device: Endorotor

Radiofrequency

ACTIVE COMPARATOR

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.

Device: Radiofrequency

Interventions

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.

EndoRotor

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.

Radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (12)

University Hospital of Brest

Brest, France

NOT YET RECRUITING

University Hospital of Tours

Chambray-lès-Tours, France

NOT YET RECRUITING

University Hospital of Lille

Lille, France

NOT YET RECRUITING

University Hospital of Limoges

Limoges, France

NOT YET RECRUITING

Edouard Herriot Hospital

Lyon, France

RECRUITING

University Hospital of Nantes

Nantes, France

NOT YET RECRUITING

University Hospital of Nice

Nice, France

NOT YET RECRUITING

Cochin Hospital

Paris, France

RECRUITING

Georges Pompidou European Hospital

Paris, France

RECRUITING

University Hospital of Bordeaux

Pessac, France

RECRUITING

University Hospital of Poitiers

Poitiers, France

NOT YET RECRUITING

University Hospital of Rennes

Rennes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Elodie CESBRON-METIVIER, Ph.D.

  UH Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie CESBRON-METIVIER, Ph.D.

CONTACT

+33241353148; elcesbronmetivier@chu-angers.fr

DRCI CHU Angers

CONTACT

+33241356329; drci-promotion-interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 30, 2021
• Study Start: March 25, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

FR (12)