Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa (RAGE)

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Medical University of Vienna

Status

Unknown

Conditions

Esophagus Disorder

Treatments

Procedure: esophagoscopy
Device: Radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT03518905
1340/2017

Details and patient eligibility

About

The heterotopic gastric mucosa found in the cervical esophagus was first described in 1805 and affects 10-15% of individuals undergoing esophagogastroduodenoscopy. It leads to laryngopharyngeal reflux (LPR), which causes symptoms like globus sensation, hoarseness and chronic cough. The Reflux Symptom Index (RSI) that ranges from 0-45 measures LPR. Scores greater than 13 are considered to be pathologic. Currently, patients that suffer from symptoms of LPR and present with a heterotopic gastric mucosa are routinely offered radiofrequency ablation (RFA) as curative treatment. Up to now, around 40 patients were already treated at the department of Surgery with 90% histologic eradication rates after 2 treatment sessions and no reported serious adverse event. Nevertheless, the placebo effect could also be responsible for perception of improving symptoms. Therefore, this prospective sham-controlled trial was designed to exclude the placebo effect. As the device is already approved and routinely used for focal ablation safety data are already available. Up to now, there were no major adverse events, whereas only 10% of patients describe a sensation of irritated throat that dissolves within the first three days after treatment.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histological proven presence of heterotopic gastric mucosa,
  • pathologic Reflux Symptom Index (>25)
  • age: 18-70
  • presence of symptoms > 6 months,
  • no effect on the Reflux Symptom Index to 12 weeks of standard dose proton pump inhibitor treatment
  • negative symptom correlation for symptoms with reflux events in ambulatory pH monitoring

Exclusion criteria

  • Not willing to participate in this study
  • pregnancy
  • lactation period

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

sham-treatment
Sham Comparator group
Description:
Patients with symptomatic large heterotopic gastric mucosa receive an esophagoscopy without radiofrequency ablation under sedation
Treatment:
Procedure: esophagoscopy
treatment arm
Active Comparator group
Description:
Patients with symptomatic large hetertotopic gastric mucosa receive an esophagoscopy with radiofrequency ablation (12J/cm2) using the Barrx channel RFA endoscopic catheter (Medtronic)
Treatment:
Device: Radiofrequency ablation

Trial contacts and locations

1

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Central trial contact

Sebastian Schoppmann, MD; Ivan Kristo, MD

Data sourced from clinicaltrials.gov

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