Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04867590

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

Led by University Hospital, Angers · Updated on 2024-04-09

140

Participants Needed

12

Research Sites

266 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with Barrett's esophagus between 2 cm and 6 cm in longest tongue length with histologically proven low to high grade dysplasia or superficial non-invasive adenocarcinoma that has been resected
  • Barrett's esophagus measurement evaluated by Prague classification with circumferential height between 0 cm and 6 cm and longest tongue height between 2 cm and 6 cm
  • Signed informed consent form
  • Pre-inclusion allowed before histological confirmation of dysplasia or adenocarcinoma
Not Eligible

You will not qualify if you...

  • Age over 85 years
  • Pregnant, breastfeeding, or laboring women
  • Individuals detained by judicial or administrative decision
  • Individuals under psychiatric treatment by force
  • Individuals under legal protection measures
  • Individuals unable to give consent
  • Individuals who do not understand or read French
  • Individuals not covered by social security or equivalent
  • Active peptic, radiation-induced, or complicated esophagitis at treatment time
  • Visible lesion suspected of esophageal cancer confirmed by biopsy
  • Incomplete or invasive adenocarcinoma resection with poor differentiation or submucosal invasion over 500 µm (pT1b)
  • Prior ablation treatments or dilation for esophageal stenosis
  • Significant esophageal stenosis preventing standard gastroscope passage
  • Presence of esophageal varices or portal hypertension
  • Anticoagulant treatment that cannot be stopped before intervention (except aspirin up to 100 mg daily) or uncorrectable bleeding disorders
  • Contraindication to anesthesia
  • Inability to take proton pump inhibitors orally

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

University Hospital of Brest

Brest, France

Not Yet Recruiting

2

University Hospital of Tours

Chambray-lès-Tours, France

Not Yet Recruiting

3

University Hospital of Lille

Lille, France

Not Yet Recruiting

4

University Hospital of Limoges

Limoges, France

Not Yet Recruiting

5

Edouard Herriot Hospital

Lyon, France

Actively Recruiting

6

University Hospital of Nantes

Nantes, France

Not Yet Recruiting

7

University Hospital of Nice

Nice, France

Not Yet Recruiting

8

Cochin Hospital

Paris, France

Actively Recruiting

9

Georges Pompidou European Hospital

Paris, France

Actively Recruiting

10

University Hospital of Bordeaux

Pessac, France

Actively Recruiting

11

University Hospital of Poitiers

Poitiers, France

Not Yet Recruiting

12

University Hospital of Rennes

Rennes, France

Not Yet Recruiting

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Research Team

E

Elodie CESBRON-METIVIER, Ph.D.

CONTACT

D

DRCI CHU Angers

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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