Stretta In Reflux Uncontrolled by IPP (SIRUP)

This study is currently recruiting participants.
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01682265
First received: September 5, 2012
Last updated: April 11, 2014
Last verified: April 2014
  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 2017
Estimated Primary Completion Date: September 2016 (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: April 11, 2014
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 April 23, 2014