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

Esophagus Disorder Clinical Trial

Official title: Radiofrequency Ablation for the Treatment of Large Symptomatic Heterotopic Gastric Mucosa - a Prospective Randomized Sham-controlled Trial - the RAGE Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Esophageal Diseases
• Esophagus Disorder

• NCT number: NCT03518905
• Study type: Interventional
• Source: Medical University of Vienna
• Contact: Ivan Kristo, MD
• Phone: +43140 40056210
• Email: ivan.kristo@meduniwien.ac.at
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2018
• Completion date: December 16, 2020