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

NCT ID: NCT00200642

Last Updated: 2008-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-10-31

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux. PPI. Radiofrequency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Stretta® System

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jean Paul Galmiche, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

BRD/03/6-F

Identifier Type: -

Identifier Source: org_study_id