Symptomatic Heterotopic Gastric Mucosa
Conditions
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.
Interventions
PROCEDURERadiofrequency ablation
Sponsors
Dr. Ivan Kristo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete histologic eradication of heterotopic gastric mucosa | 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
| Measure | Time frame | Description |
|---|---|---|
| symptom assessment | measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination | visual analog scale 0-10 (0=no interference, 10=maximum interference) is used for the symptom assessment of globus sensation |
| laryngopharyngeal reflux | at the beginning of the study period and 12 weeks after last endoscopic examination | the Reflux Finding Index is used for assessment of laryngopharyngeal reflux |
| 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 | telephone calls |
| laryngopharyngeal reflux II | 1 year after first ablation | the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux at the end of the study period |
Outcome results
None listed