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

January 13, 2017 updated by: Dr. Ivan Kristo
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with macroscopic and histologic evidence of large (≥ 20mm diameter) heterotopic gastric mucosa.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing radio frequency ablation
Patients undergoing radio frequency for large symptomatic heterotypic gastric mucosa
Procedure: Radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 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
measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination
laryngopharyngeal reflux
Time Frame: 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
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
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
Time Frame: adverse events are assessed within the first week after interventions
telephone calls
adverse events are assessed within the first week after interventions
laryngopharyngeal reflux II
Time Frame: 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
1 year after first ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Ivan Kristo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

December 24, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 18, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1723/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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