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

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

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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