Clinical trial NCT01682265: Stretta In Reflux Uncontrolled by IPP
Official title: Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Efficiency of the treatment 6 months post-procedure
timeFrame: 6 months
Secondary outcomes:
measure: Effects on digestive symptoms
timeFrame: 6 months
measure: Effects on digestive symptoms
timeFrame: 1 year
measure: Necessity of IPP treatment
timeFrame: 6 months
measure: necessity of IPP treatment
timeFrame: 1 year
measure: Tolerance
timeFrame: 6 months
measure: Tolerance
timeFrame: 1 year
measure: Quality of live
timeFrame: 6 months
measure: Quality of life
timeFrame: 1 year
measure: pH-impedancemetry predictive factors
timeFrame: At Inclusion
measure: Efficiency
timeFrame: 1 year
measure: Efficiency
timeFrame: 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital
state: Loire Atlantique
city: Bordeaux
country: France
facility: Bordeaux Universitary Hospital
city: Brest
country: France
facility: Brest universitary hospital
city: Colombes
country: France
facility: APHP - Louis Mourier hospital
city: Lyon
country: France
facility: Lyon Universitary Hospital
city: Rouen
country: France
facility: Rouen Universitary Hospital
Study officials:
affiliation: Nantes Universitary Hospital
name: Stanislas Bruley des Varannes, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rouen Universitary Hospital
name: Chloe Melchior, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon Universitary Hospital
name: Thierry Ponchon, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Bordeaux Universitary Hospital
name: Franck Zerbib, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Brest Universitary hospital
name: Franck Cholet, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP-Louis Mourier hospital
name: Benoit Coffin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.