Actively Recruiting
A Controlled, Randomised Multicenter Study Comparing EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus with Dysplasia
Led by University Hospital, Angers · Updated on 2024-04-09
140
Participants Needed
12
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new treatment options for Barrett's Esophagus, a condition where the esophageal lining changes and carries a risk of progressing to precancerous stages or cancer. The study compares a new mechanical resection technique using the EndoRotor device against the current standard treatment of thermal destruction by radiofrequency ablation. This comparison aims to find a potentially more effective and cost-efficient method for eradicating Barrett's Esophagus, especially in cases complicated by dysplasia or superficial adenocarcinoma. The study involves two treatment groups: one receiving the EndoRotor procedure, which mechanically removes the entire mucosal surface in a single session, allowing tissue collection for analysis; the other receiving thermal ablation with the HALO system using radiofrequency energy applied after mucosal cleaning. Each technique has specific procedural steps and devices used. The EndoRotor treatment includes submucosal injection to reduce risks, followed by mucosal resection and tissue aspiration. Radiofrequency treatment involves sizing the esophagus and applying energy via specialized probes to destroy the abnormal mucosa. Participants will undergo endoscopic evaluations before and after treatment, with biopsies taken to assess the presence or absence of Barrett's Esophagus and dysplasia at 3 and 12 months. Safety assessments include monitoring discomfort, pain, dysphagia, adverse events, and esophageal narrowing after treatment. Researchers will also evaluate the quality of tissue analysis from EndoRotor samples and economic outcomes such as cost-effectiveness. The study continues through follow-up visits up to 12 months post-treatment to measure treatment success and safety.
CONDITIONS
Brief Title
A Study Comparing the Effectiveness of EndoRotor Versus Radiofrequency in Treating Barrett's Esophagus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with Barrett's Esophagus length between 2 cm and 6 cm measured by Prague classification
- Histologically confirmed low to high grade dysplasia or superficial non-invasive adenocarcinoma
- Signed informed consent form
- Pre-included patients before histological confirmation of dysplasia or superficial adenocarcinoma
You will not qualify if you...
- Age over 85 years
- Women who are pregnant, breastfeeding, or in labor
- Individuals detained by judicial or administrative decision
- Individuals under forced psychiatric treatment
- Individuals under legal protection measures
- Individuals unable to give informed consent
- Individuals who do not understand French or cannot read
- Individuals not covered by a social security scheme
- Active peptic, radiation-induced, or complicated esophagitis at treatment time
- Visible esophageal lesion suspected as cancer confirmed by biopsy
- Previous invasive adenocarcinoma resection with poor prognosis features
- Previous ablation treatments or esophageal dilation
- Significant esophageal stenosis blocking standard gastroscope
- Presence of esophageal varices or portal hypertension
- Anticoagulant therapy that cannot be stopped (except low-dose aspirin)
- Contraindications to anesthesia
- Inability to take proton pump inhibitors orally
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive treatment with either the EndoRotor system or the Radiofrequency HALO system to remove or ablate the Barrett's esophagus mucosa using endoscopic techniques.
1 treatment visit (in-person)
Duration - Up to 12 months after treatment
Participants are monitored for treatment effectiveness and safety, including endoscopic check-ups and biopsies to assess eradication of Barrett's esophagus and adverse events.
Follow-up visits at 3 months and 12 months post-treatment
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
Research Team
E
Elodie CESBRON-METIVIER, Ph.D.
D
DRCI CHU Angers
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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