CompletedPhase 4

Radiofrequency in the Treatment of Barrett's Oesophagus

France87 participantsStarted 2013-01-07

Plain-language summary

First intent treatment for superficial circular esophageal neoplasm is surgical resection. Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal stenosis (higher than 80%). Surgical limits are related to a high level of morbidity due, in particular, to respiratory complications or infections that require prolonged hospitalisations, and by significant rate of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative technique to remove esophageal circular preneoplastic and neoplastic lesions has been developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which incorporates approximately 100 electrodes on its surface that emit radiofrequency waves (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration of the electrical impulses, it is possible to obtain a homogenous and controlled destruction of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than half of the circumference of the esophagus and that requires surgical treatment. The expected benefit for the patient is linked to the reduced invasiveness of the technique in comparison to the surgery

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age over 18 years, * General Condition WHO 0, 1 or 2, * ASA Class I and II, eligible for endoscopic or surgical treatment with curative intent, * Histological diagnosis of high grade glandular epithelial neoplasia (Vienna 4-1 to 4-46), possibly multifocal or stage 0 (Tis, N0, M0), * Endoscopic and histological confirmed diagnosis of intestinal metaplasia, * Histological diagnosis confirmed by two endoscopies with biopsies and two pathological readings; biopsies should be carried out according to the protocol of the SFED (four-quadrant biopsies every cm) with at least once acetic acid for staining. Operators describe Barrett's esophagus using he SFED planimetric model. The final exam will be no more than two months before the date of treatment and should have been achieved in investigator establishment, * Extension height of Barrett's esophagus upstream of the upper part of the gastric folds or palisade vessels: * Minimum 1 cm, * Maximum 12 cm. * In case of previous treatment by mucosal resection or submucosal dissection (DSM) for severe dysplasia or microinvasive carcinoma: * the resected lesion must have been well differentiated and confined to the muscular mucosa (m3 maximum) on histological analysis, * resection should be more than two months, * resection must have been macroscopically complete laterally, * resection must have been histologically complete in depth, * resection must have been histologically complete laterally with rega…

What they're measuring

complete histological eradication of the high grade glandular epithelial neoplasia

Timeframe: 12 months after the end of treatment

Trial details

NCT IDNCT02558504

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-18