Stretta In Reflux Uncontrolled by IPP

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Other: Stretta procedure; Other: Sham procedure

• Registration Number: NCT01682265
• Lead Sponsor: Nantes University Hospital

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)

Study Timeline

• Study Start: 2012-03-26
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stretta procedure	Stretta procedure	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.
Sham procedure	Sham procedure	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Necessity of IPP treatment	6 months	Compare Stretta and sham procedure according to necessity of IPP treatment
Effects on digestive symptoms	1 year	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)
Quality of live	6 months	Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)
Tolerance	1 year	Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.
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.
necessity of IPP treatment	1 year	Compare Stretta and sham procedure according to necessity of IPP treatment
Quality of life	1 year	Compare Stretta and sham procedure according to Quality of life
Efficiency	1 year	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

Trial Locations

Locations (6)

Lyon Universitary Hospital; 🇫🇷 Lyon, France

APHP - Louis Mourier hospital; 🇫🇷 Colombes, France

Brest universitary hospital; 🇫🇷 Brest, France

Rouen Universitary Hospital; 🇫🇷 Rouen, France

Nantes Universitary Hospital; 🇫🇷 Nantes, Loire Atlantique, France

Bordeaux Universitary Hospital; 🇫🇷 Bordeaux, France