Stretta In Reflux Uncontrolled by IPP

Gastroesophageal Reflux Disease Clinical Trial

— SIRUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682265
• Other study ID #: BRD/11/06-Q
• Status: Completed
• Phase: N/A
• Start date: March 26, 2012
• Est. completion date: November 27, 2018

Study information

• Verified date: January 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Other:
• Stretta procedure

• Sham procedure
No radiofrequency delivered

Locations

Country	Name	City	State
France	Bordeaux Universitary Hospital	Bordeaux
France	Brest universitary hospital	Brest
France	APHP - Louis Mourier hospital	Colombes
France	Lyon Universitary Hospital	Lyon
France	Nantes Universitary Hospital	Nantes	Loire Atlantique
France	Rouen Universitary Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Necessity of IPP treatment	Compare Stretta and sham procedure according to necessity of IPP treatment	6 months
Secondary	necessity of IPP treatment	Compare Stretta and sham procedure according to necessity of IPP treatment	1 year
Secondary	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
Secondary	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
Secondary	Quality of live	Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)	6 months
Secondary	Quality of life	Compare Stretta and sham procedure according to Quality of life	1 year
Secondary	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
Secondary	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
Secondary	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