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

Dr. Ivan Kristo10 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Symptomatic Heterotopic Gastric Mucosa

Interventions

Radiofrequency ablationPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

the change from gastric epithelium to squamous epithelium is monitored by histological sampling throughout the study period

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.

Secondary Outcomes

symptom assessment

visual analog scale 0-10 (0=no interference, 10=maximum interference) is used for the symptom assessment of globus sensation

Time frame: 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

Time frame: at the beginning of the study period and 12 weeks after last endoscopic examination

SF-12 quality of life

Time frame: 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

Time frame: 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

Time frame: 1 year after first ablation