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OpenTrials
Completed

NCT Number: NCT03023280

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

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.

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Key information

Conditions

Symptomatic Heterotopic Gastric Mucosa

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. SF-12 quality of life

    Time frame: at the beginning of the study (before ablations) and 12 weeks after final endoscopic examination

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Dr. Ivan Kristo

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2017
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.