Stretta In Reflux Uncontrolled by IPP (SIRUP)
This study is currently recruiting participants.
Verified September 2012 by Nantes University Hospital
Sponsor:
Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01682265
First received: September 5, 2012
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastroesophageal Reflux Disease |
Other: Stretta procedure Other: Sham procedure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study |
Resource links provided by NLM:
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- Efficiency of the treatment 6 months post-procedure [ Time Frame: 6 months ] [ Designated as safety issue: No ]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:
- Effects on digestive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]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)
- Effects on digestive symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]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)
- Necessity of IPP treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Compare Stretta and sham procedure according to necessity of IPP treatment
- necessity of IPP treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]Compare Stretta and sham procedure according to necessity of IPP treatment
- Tolerance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24.
- Tolerance [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.
- Quality of live [ Time Frame: 6 months ] [ Designated as safety issue: No ]Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)
- Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]Compare Stretta and sham procedure according to Quality of life
- pH-impedancemetry predictive factors [ Time Frame: At Inclusion ] [ Designated as safety issue: No ]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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
- Efficiency [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Other: Stretta procedure
Other Name: Radiofrequency of esophagus
|
|
Sham Comparator: 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. |
Other: Sham procedure
No radiofrequency delivered
|
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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682265
Contacts
| Contact: Stanislas Bruley des Varannes, Professor | +33 2.40.08.33.06 | stanilas.bruleydesvarannes@chu-nantes.fr |
Locations
| France | |
| Nantes Universitary Hospital | Recruiting |
| Nantes, Loire Atlantique, France, 44093 | |
| Contact: Stanislas Bruley des Varannes, Professor | |
| Principal Investigator: Stanislas Bruley des Varannes, Professor | |
| Bordeaux Universitary Hospital | Not yet recruiting |
| Bordeaux, France | |
| Contact: Franck Zerbib, Professor +33 5 56 79 58 06 frank.zerbib@chu-bordeaux.fr | |
| Principal Investigator: Franck Zerbib, Professor | |
| Lyon Universitary Hospital | Recruiting |
| Lyon, France, 69000 | |
| Contact: Thierry Ponchon, Professor +33 472110149 thierry.ponchon@chu-lyon.fr | |
| Principal Investigator: Thierry Ponchon, Professor | |
| Rouen Universitary Hospital | Not yet recruiting |
| Rouen, France, 76000 | |
| Contact: Philippe Ducrotte, Professor +33 2 32 88 81 01 philippe.ducrotte@chu-rouen.fr | |
| Principal Investigator: Philippe Ducrotte, Professor | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Stanislas Bruley des Varannes, Professor | Nantes Universitary Hospital |
| Principal Investigator: | Philippe Ducrotte, Professor | Rouen Universitary Hospital |
| Principal Investigator: | Thierry Ponchon, Professor | Lyon Universitary Hospital |
| Principal Investigator: | Franck Zerbib, Professor | Bordeaux Universitary Hospital |
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01682265 History of Changes |
| Other Study ID Numbers: | BRD 11/6-Q |
| Study First Received: | September 5, 2012 |
| Last Updated: | September 10, 2012 |
| Health Authority: | France-':ANSM' |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013