Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation

Study Overview
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Brief Summary
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Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to concerns of stricture formation. Therefore, the investigators aimed to investigate the effect of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment of large symptomatic CIP.

Conditions
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Symptomatic Heterotopic Gastric Mucosa

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: negative PPI trial, ph-metry without correlation on globus sensation, prior high-resolution manometry Exclusion Criteria: not willing to participate in follow up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing radio frequency ablation<br>Patients undergoing radio frequency for large symptomatic heterotypic gastric mucosa | Procedure: Radiofrequency ablation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete histologic eradication of heterotopic gastric mucosa | the change from gastric epithelium to squamous epithelium is monitored by histological sampling throughout the study period | measured endoscopically throughout the study period. First time point of measurement is 3 months after first ablation. Further measurements are carried out 3 months after subsequent ablations up to a maximum number of three ablations. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom assessment | visual analog scale 0-10 (0=no interference, 10=maximum interference) is used for the symptom assessment of globus sensation | measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination | 
| laryngopharyngeal reflux | the Reflux Finding Index is used for assessment of laryngopharyngeal reflux | at the beginning of the study period and 12 weeks after last endoscopic examination | 
| SF-12 quality of life |  | at the beginning of the study (before ablations) and 12 weeks after final endoscopic examination | 
| number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | telephone calls | adverse events are assessed within the first week after interventions | 
| laryngopharyngeal reflux II | the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux at the end of the study period | 1 year after first ablation |