Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Primary Endpoint
- Complete histologic eradication of heterotopic gastric mucosa
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Complete histologic eradication of heterotopic gastric mucosa
Time Frame: 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.
the change from gastric epithelium to squamous epithelium is monitored by histological sampling throughout the study period
Secondary Outcomes
- symptom assessment(measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination)
- 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(adverse events are assessed within the first week after interventions)
- laryngopharyngeal reflux II(1 year after first ablation)
Investigators
Dr. Ivan Kristo
Dr.med.univ.
Medical University of Vienna