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The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham-treatment | Sham Comparator | Patients with symptomatic large heterotopic gastric mucosa receive an esophagoscopy without radiofrequency ablation under sedation |
|
| treatment arm | Active Comparator | Patients with symptomatic large hetertotopic gastric mucosa receive an esophagoscopy with radiofrequency ablation (12J/cm2) using the Barrx channel RFA endoscopic catheter (Medtronic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Device | Radiofrequency ablation is performed using the Barrx Channel endoscopic catheter (Medtronic, Dublin, Republic of Ireland) generating an energy density level of 12 Joule/cm2. The energy is applied using a simplified protocol of three ablations without removal of coagulated tissue. The device is used on a routinely basis all around the world and already approved. The ablation catheter is applied through the working channel of the endoscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Normalization of the Reflux Symptom Index | Normalization of the Reflux Symptom Index (RSI <14) after two treatment/sham sessions evaluated 3 months after the second (sham-) treatment (therefore 6 months after the first endoscopy with/without RFA). Proton-pump inhibitors are paused 8 weeks before assessment | 6 months after first RFA treatment/or sham procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Histological eradication rate after radiofrequency ablation or sham treatment | Histologic eradication rate after RFA treatment/sham procedure measured after finalization of RFA (normalization of Reflux Symptom Index/or a maximum of two treatment sessions) or at the time of second sham treatment. | 6 months after first RFA treatment/or sham procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Kristo, MD | Contact | +43140 40056210 | ivan.kristo@meduniwien.ac.at | |
| Sebastian Schoppmann, MD | Contact | +43140 40056210 | sebastian.schoppmann@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D004945 | Esophagoscopy |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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randomized sham-controlled
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Patients are blinded either to sham or treatment and unblinded after 24 weeks after final examination
|
| esophagoscopy | Procedure | Patients receive an esophagoscopy without radiofrequency ablation under sedation |
|
| SF-12 quality of life | At enrollment (therefore before ablations or sham treatment) and 6 months after first radiofrequency ablation/sham treatment |
| Reflux Finding Score | the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux. The reflux finding score (RFS) represents an objective and validated instrument to analyze physical findings and severity of laryngopharyngeal reflux. An 8-item checklist with excellent inter-observer reliability grades abnormalities documented during laryngoscopy from 0-26 points. The total score is reported and summed from an 8 item checklist providing 0-4 points. Statistically, total scores greater than 7 have a likelihood of 95% to reflect LPR. Higher scores represent worse outcomes. | Evaluated at the first intervention at study completion after 6 months |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D019060 | Minimally Invasive Surgical Procedures |