Stretta In Reflux Uncontrolled by IPP (SIRUP)

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Other: Stretta procedure; Other: Sham procedure

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Bordeaux Universitary Hospital
  • Brest, France, 29200
    • Brest universitary hospital
  • Colombes, France, 92700
    • APHP - Louis Mourier hospital
  • Lyon, France, 69000
    • Lyon Universitary Hospital
  • Rouen, France, 76000
    • Rouen Universitary Hospital
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Nantes Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Stanislas Bruley des Varannes, Professor, Nantes Universitary Hospital; Principal Investigator: Chloe Melchior, Doctor, Rouen Universitary Hospital; Principal Investigator: Thierry Ponchon, Professor, Lyon Universitary Hospital; Principal Investigator: Franck Zerbib, Professor, Bordeaux Universitary Hospital; Principal Investigator: Franck Cholet, Doctor, Brest universitary hospital; Principal Investigator: Benoit Coffin, Professor, APHP-Louis Mourier hospital

Publications and helpful links

General Publications

• Zerbib F, Sacher-Huvelin S, Coron E, Coffin B, Melchior C, Ponchon T, Cholet F, Chabrun E, Vavasseur F, Gorbatchef C, Zalar A, Mion F, Robaszkiewicz M, Le Rhun M, Leroy M, Paul Galmiche J, Bruley des Varannes S. Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn. Aliment Pharmacol Ther. 2020 Aug;52(4):637-645. doi: 10.1111/apt.15936. Epub 2020 Jul 13.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2012
• Primary Completion (Actual): November 27, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 10, 2012

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: BRD/11/06-Q