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Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200642
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 22, 2008
Information provided by:
Nantes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Device: Stretta® System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease
Study Start Date : December 2003
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. The evaluation of tolerance,
  2. the description of potential complications entailed by the technique and the measure of GERD recurrence rate on patients over a one-year period.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient above 18 years old
  2. Suffering from typical symptoms of reflux (heartburn and/or acid regurgitation and/or epigastric burns with ascending radiations)
  3. Symptoms occurring at least 3 times a week without treatment
  4. Symptoms disappearing under full doses PPI treatment
  5. Requiring a continuous treatment for more than 3 months to get rid of symptoms (or nearly)
  6. Total consent signed from patient

Exclusion Criteria:

  1. Contraindications to the radiofrequency technique:

    • Columnar lined oesophagus ³ 3 cm height
    • Barret's mucosa presenting dysplasia
    • History of treated columnar lined oesophagus
    • Hiatus hernia with a size over 3 cm
    • History of Stage C or D esophagitis in the Los Angeles classification (18), or in progress
    • History of oesophageal stenosis
    • History of gastric or oesophageal surgery
    • Presence of oesophageal and/or cardial varicose veins
    • Presence of a cardiac pacemaker or implanted defibrillator (when confirmed by the manufacturer that use of RF energy will not interfere, it's ok to do patients!)
    • Impossibility to interrupt a anticoagulant treatment or serious disorders of haemostasis
  2. General contraindications:

    • Contraindication to general anaesthesia
    • Existence of an associated serious disease making fear that the patient will live less than a year
    • Incapacity to understand and sign a sensible consent of participation to the study
    • Chronic alcoholism defined by a daily consumption of alcohol over 60 g
    • Morbid obesity defined by a rate of body mass higher that 35
    • Patients suffering from atypical GERD symptoms (especially extra-digestive) will not be included in the study if these symptoms are not associated with typical reflux symptoms (heartburn or regurgitation)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00200642

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Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Jean Paul Galmiche, MD Nantes UH
Layout table for additonal information Identifier: NCT00200642    
Other Study ID Numbers: BRD/03/6-F
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008
Keywords provided by Nantes University Hospital:
Gastroesophageal reflux. PPI. Radiofrequency
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases