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

Completed

• Conditions: Symptomatic Heterotopic Gastric Mucosa
• Interventions: Procedure: Radiofrequency ablation

• Registration Number: NCT03023280
• Lead Sponsor: Dr. Ivan Kristo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-12-24
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing radio frequency ablation	Radiofrequency ablation	Patients undergoing radio frequency for large symptomatic heterotypic gastric mucosa

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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