Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients' quality of life. To alleviate symptoms and ease the healing of lesion, patients very often need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which, despite their efficiency, do not cure the disease. For these PPI dependent patients, an anti-reflux surgery (fundoplication often made by coelioscopy) is a possible alternative but it has a significant morbidity rate and even an estimated post-operative mortality of 0.8% outside of expertise centres. Therefore, new therapeutic endoscopic approaches, supposed to be less invasive and less expensive than surgery have been developed during the last three years. Among them, radiofrequency (Stretta® procedure) consists in administering a high frequency current in the cardia area, in order to induce thanks to a thermal effect a sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of this project carried out in 8 French centres and 2 European centers is to assess through a randomised trial, the efficiency of radiofrequency on PPI dependent patients. The study will be carried out in 2 phases with patients who have been fully informed of the project statement, and particularly of the potential risks of the radiofrequency technique and have given their written acceptation to participate to the study.The first phase, which will last 6 to 11 weeks, will aim at making sure that patients are PPI dependent and define their needs. After this initial phase, patients will be randomised between those who will carry on with the PPI treatment or the radiofrequency treatment. The follow up after this randomisation will last one year. The first assessment of the therapeutic efficiency will be done at 6th month. The 6 additional follow up months will be required for the assessment of mid-term side effects of the treatment and the rate of symptomatic recurrences.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease|
- The main endpoint will be the possibility or not to stop the PPI treatment (or to reduce the dose by at least 50%), 6 months after administering (or not) just one radiofrequency session.
- The evaluation of tolerance,
- the description of potential complications entailed by the technique and the measure of GERD recurrence rate on patients over a one-year period.
|Study Start Date:||December 2003|
|Study Completion Date:||October 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200642
|Nantes University Hospital|
|Nantes, France, 44093|
|Principal Investigator:||Jean Paul Galmiche, MD||Nantes UH|