Radiofrequency in the Treatment of Barrett's Oesophagus (HARMONI)
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|ClinicalTrials.gov Identifier: NCT02558504|
Recruitment Status : Unknown
Verified October 2015 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : September 24, 2015
Last Update Posted : October 7, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasm||Procedure: Oesophagectomy Device: Radiofrequency ablation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Active Comparator: Oesophagectomy
While surgical reference technique for invasive cancer of the lower esophagus is the technique according to Lewis Santy, there is no consensus on the technique and surgical approaches lack of specific work in the particular case of superficial lesions . The centers will have the choice of using the technique according to Lewis Santy with gastric plasty or technique of esophagectomy without thoracotomy with lower mediastinal dissection. In the absence of consensus to date available, abdominal surgery time will be by laparotomy or laparoscopy (laparoscopic assisted technique called). In both cases, an exploratory laparoscopy for diagnostic purposes is realized to remove an extension of the disease that would indicate against-resection with curative intent. For surgery, patients will be put under antisecretory therapy proton-pump inhibitor; this at least throughout the duration of the study.
Experimental: Radiofrequency ablation
The equipment processing is:
The radiofrequency treatment should be carried out according to the following protocol:
Device: Radiofrequency ablation
Other Name: esophageal radiofrequency
- complete histological eradication of the high grade glandular epithelial neoplasia [ 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.
- Rate of complete histological eradication of Barret's oesophagus [ Time Frame: 12 months after the end of treatment ]
- Rate of mortality all causes merged [ Time Frame: 12 months after the end of treatment ]
- Rate of mortality attributable to the procedure [ Time Frame: 30 days after end of the treatment ]
- Percentage of patients with severe adverse reaction and minor adverse reactions linked to the procedure used, described by anatomical site [ Time Frame: 30 days and 12 months after end of the treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558504
|Contact: Valérie PLATTNER, MDemail@example.com|
|Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot||Recruiting|
|Lyon, France, 69003|
|Contact: Thierry PONCHON, MD|
|Contact: Pascale GUERRE 00334 72 11 51 66 firstname.lastname@example.org|