Gastroesophageal Reflux Disease
Conditions
Brief summary
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP) patients.
Detailed description
The study is over a period of 1 year. After checking eligibility, the patient will be randomised in double blind : stretta procedure /sham procedure. Control visits will take place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and 24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated. In case of success, endoscopic control will be performed and the patient will come back on site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure. The procedure will be scheduled between week 24 and week 27. The patient will come back for a visit on site at weeks 31, 36 and 48 (end of visit)
Interventions
OTHERStretta procedure
OTHERSham procedure
No radiofrequency delivered
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 ans * Severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with IPP
Exclusion criteria
* Recent oeso-gastro-duodenal endoscopy(\< 3 months) * Oesophagitis \> grade A * Endobrachyoesophagus \> C0M1 * Hiatal Hernia \> 2 cm * Symptoms insufficiently relieved with continued intake of IPP or with intake of IPP according to needs * Predominant symptom of Gastrooesophageal reflux disease other than heartburn * Patients contra-indicated for radiofrequency technique * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficiency of the treatment 6 months post-procedure | 6 months | Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on digestive symptoms | 6 months | Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 6 months) |
| Necessity of IPP treatment | 6 months | Compare Stretta and sham procedure according to necessity of IPP treatment |
| necessity of IPP treatment | 1 year | Compare Stretta and sham procedure according to necessity of IPP treatment |
| Tolerance | 6 months | Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24. |
| Quality of live | 6 months | Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries) |
| Quality of life | 1 year | Compare Stretta and sham procedure according to Quality of life |
| pH-impedancemetry predictive factors | At Inclusion | pH-impedancemetry will be realized at clinical trial start, when patient is under PPI intake to determine pH-impedancemetry predictive factors for positive response to stretta method. Acid and non acid exposition of the esophagus will be measured as well as the SAP (Symptom Association Probability) which corresponds to the probability of association between symptoms felt by the patient during the pH-impedancemetry and episodes of acid or non acid reflux. |
| Efficiency | 1 year | Evaluate efficiency of the stretta procedure in patients unsatisfied after the sham procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORStanislas Bruley des Varannes, Professor
Nantes Universitary Hospital
PRINCIPAL_INVESTIGATORChloe Melchior, Doctor
Rouen Universitary Hospital
PRINCIPAL_INVESTIGATORThierry Ponchon, Professor
Lyon Universitary Hospital
PRINCIPAL_INVESTIGATORFranck Zerbib, Professor
Bordeaux Universitary Hospital
PRINCIPAL_INVESTIGATORFranck Cholet, Doctor
Brest Universitary hospital
PRINCIPAL_INVESTIGATORBenoit Coffin, Professor
APHP-Louis Mourier hospital
Outcome results
None listed