Stretta In Reflux Uncontrolled by IPP

Study Overview
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Brief Summary
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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
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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)

Official Title
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Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Other: Stretta procedure
* Other: Sham procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stretta procedure<br>Patient randomized in Stretta procedure arm will be hospitalized to have endoscopy and esophagus will receive radiofrequency. Control visits will then take place until Month 6. At this visit endoscopic control will take place. | Other: Stretta procedure<br> <br> * Other names: Radiofrequency of esophagus;|
| Sham Comparator: Sham procedure<br>Patient randomized in Sham procedure arm will be hospitalized to have endoscopy. Material necessary to perform Stretta procedure will be inserted (like in Stretta procedure arm) BUT esophagus will not receive radiofrequency. Control visits will then take place until Month 6. At this visit endoscopic control will take place. | Other: Sham procedure<br>* No radiofrequency delivered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency of the treatment 6 months post-procedure | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on digestive symptoms | 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) | 6 months | 
| Effects on digestive symptoms | 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 12 months) | 1 year | 
| Necessity of IPP treatment | Compare Stretta and sham procedure according to necessity of IPP treatment | 6 months | 
| necessity of IPP treatment | Compare Stretta and sham procedure according to necessity of IPP treatment | 1 year | 
| Tolerance | Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24. | 6 months | 
| Tolerance | Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48. | 1 year | 
| Quality of live | Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries) | 6 months | 
| Quality of life | Compare Stretta and sham procedure according to Quality of life | 1 year | 
| pH-impedancemetry predictive factors | 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. | At Inclusion | 
| Efficiency | 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 | 1 year | 
| Efficiency | Evaluate efficiency of the 2nd stretta procedure in patients unsatisfied after the 1st stretta 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 | 1 year |