Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot
Lyon, 69003, France
NCT Number: NCT02558504
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
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lyon, 69003, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VEMS (Maximum Expiratory Volume Second) <1L / min
PaO2 <60 mmHg
PaCO2> 45 mmHg
Other names: esophageal radiofrequency
Time frame: 12 months after the end of treatment
The rate of success of the technique, success being defined as the complete histological eradication of the high grade glandular epithelial neoplasia without death attributable to the procedure. The relation of a death to the procedure will be determined by a committee of experts consisting of 3 surgeons or 3 hepatogastroenterologists depending on the arm, who do not participate to the study.
Time frame: 12 months after the end of treatment
Time frame: 12 months after the end of treatment
Time frame: 30 days after end of the treatment
Time frame: 30 days and 12 months after end of the treatment
Hospices Civils de Lyon
Other
Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus
Acronym: HARMONI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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