Symptomatic Heterotopic Gastric MucosaNCT03023280
Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation
An observational study of Symptomatic Heterotopic Gastric Mucosa, run by Dr. Ivan Kristo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Heterotopic Gastric Mucosa
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with macroscopic and histologic evidence of large (≥ 20mm diameter) heterotopic gastric mucosa.
Who may be able to join
- negative PPI trial, ph-metry without correlation on globus sensation, prior high-resolution manometry
Who cannot join
- not willing to participate in follow up
About this study
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.
- Conditions
- Symptomatic Heterotopic Gastric Mucosa
- Being tested
- Radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing radio frequency ablation | Patients undergoing radio frequency for large symptomatic heterotypic gastric mucosa Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete histologic eradication of heterotopic gastric mucosa
the change from gastric epithelium to squamous epithelium is monitored by histological sampling throughout the study period
Measured: 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 (5)
symptom assessment
visual analog scale 0-10 (0=no interference, 10=maximum interference) is used for the symptom assessment of globus sensation
Measured: 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
Measured: at the beginning of the study period and 12 weeks after last endoscopic examination
SF-12 quality of life
Measured: 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
Measured: 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
Measured: 1 year after first ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startSep 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Heterotopic Gastric MucosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ivan Kristo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Ivan Kristo, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023280
- Sponsor's protocol ID
- 1723/2015
- Status last verified
- Jan 2017
- First submitted
- 24 Dec 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristo I, Rieder E, Paireder M, Schwameis K, Jomrich G, Dolak W, Parzefall T, Riegler M, Asari R, Schoppmann SF. Radiofrequency ablation in patients with large cervical heterotopic gastric mucosa and globus sensation: Closing the treatment gap. Dig Endosc. 2018 Mar;30(2):212-218. doi: 10.1111/den.12959. Epub 2017 Oct 3.
PubMed 28884487
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation
- ClinicalTrials.gov ID
- NCT03023280
- Acronym / sponsor ID
- 1723/2015
- Conditions
- Symptomatic Heterotopic Gastric Mucosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dr. Ivan KristoUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radio frequency ablation | – | Procedure: Radiofrequency ablationPatients undergoing radio frequency for large symptomatic heterotypic gastric mucosa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with macroscopic and histologic evidence of large (≥ 20mm diameter) heterotopic gastric mucosa.
Key inclusion criteria (1 listed)
- negative PPI trial, ph-metry without correlation on globus sensation, prior high-resolution manometry
Key exclusion criteria (1 listed)
- not willing to participate in follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation | Procedure or surgery | Patients undergoing radio frequency ablation |
Primary outcome
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
5 secondary outcomes
symptom assessment
Time frame: 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
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
Time frame: adverse events are assessed within the first week after interventions
laryngopharyngeal reflux II
Time frame: 1 year after first ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 28884487Kristo I, Rieder E, Paireder M, Schwameis K, Jomrich G, Dolak W, Parzefall T, Riegler M, Asari R, Schoppmann SF. Radiofrequency ablation in patients with large cervical heterotopic gastric mucosa and globus sensation: Closing the treatment gap. Dig Endosc. 2018 Mar;30(2):212-218. doi: 10.1111/den.12959. Epub 2017 Oct 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Heterotopic Gastric Mucosa, run by Dr. Ivan Kristo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.