Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stretta procedure | Experimental | 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. |
|
| Sham procedure | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretta procedure | Other |
|
| |
| Sham procedure |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Universitary Hospital | Nantes | Loire Atlantique | 44093 | France | ||
| Bordeaux Universitary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32656869 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
No radiofrequency delivered |
|
| 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 |
| Bordeaux |
| France |
| Brest universitary hospital | Brest | 29200 | France |
| APHP - Louis Mourier hospital | Colombes | 92700 | France |
| Lyon Universitary Hospital | Lyon | 69000 | France |
| Rouen Universitary Hospital | Rouen | 76000 | France |
| D004066 | Digestive System Diseases |