Stretta In Reflux Uncontrolled by IPP (SIRUP)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Gastroesophageal Reflux Disease

Treatments: Other: Sham procedure; Other: Stretta procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01682265

BRD/11/06-Q

Details and patient eligibility

About

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.

Full 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)

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

62 participants in 2 patient groups

Stretta procedure

Experimental group

Description:

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.

Treatment:

Other: Stretta procedure

Sham procedure

Sham Comparator group

Description:

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.

Treatment:

Other: Sham procedure