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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
University Hospital of Brest
NOT_YET_RECRUITING
Brest
University Hospital of Tours
NOT_YET_RECRUITING
Chambray-lès-tours
University Hospital of Lille
NOT_YET_RECRUITING
Lille
University Hospital of Limoges
NOT_YET_RECRUITING
Limoges
Edouard Herriot Hospital
RECRUITING
Lyon
University Hospital of Nantes
NOT_YET_RECRUITING
Nantes
University Hospital of Nice
NOT_YET_RECRUITING
Nice
Cochin Hospital
RECRUITING
Paris
Georges Pompidou European Hospital
RECRUITING
Paris
University Hospital of Bordeaux
RECRUITING
Pessac
University Hospital of Poitiers
NOT_YET_RECRUITING
Poitiers
University Hospital of Rennes
NOT_YET_RECRUITING
Rennes
Contact Information
Primary
Elodie CESBRON-METIVIER, Ph.D.
elcesbronmetivier@chu-angers.fr
+33241353148
Backup
DRCI CHU Angers
drci-promotion-interne@chu-angers.fr
+33241356329
Time Frame
Start Date: 2022-03-25
Estimated Completion Date: 2027-05
Participants
Target number of participants: 140
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov