Radiofrequency Ablation vs Sham Procedure for Symptomatic Cervical Inlet Patch

Barrett Esophagus Clinical Trial

Official title: Randomised Controlled Trial of Radiofrequency Ablation Versus a Sham Procedure for Symptomatic Cervical Inlet Patch

Status Recruiting

Clinical Trial Summary

Inlet patch is a congenital condition of the upper oesophagus, consisting of stomach lining that is in the wrong place. It affects 5% of the population. Symptoms are a feeling of a ball in the back of the throat (called chronic globus sensation), cough and sore throat - these account for 4% of general practitioner (GP) referral to Ear Nose & Throat departments.

There is no recognised treatment. Drugs that reduce acid may help but do not block mucus production. Argon Plasma coagulation has been shown to be successful but limited to a few expert centres. The investigators have previously shown a device that uses radiofrequency energy to remove the patch to be highly effective in a ten patient pilot study, with 80% response rate that was durable over 1 year.

The purpose of this trial is to demonstrate the previous study was not due to placebo effect alone, with a sham controlled arm. Patients would then crossover to treatment at 6 months after sham. All males and non-pregnant females over 18 years old with previously diagnosed inlet patch causing symptoms of globus, with > 50% severity on a visual analogue score, are eligible.

Clinical Trial Description

Inlet patch is a congenital anomaly of the upper oesophagus, consisting of stomach lining that is in an aberrant position. Prevalence is up to 10% on endoscopy studies and 5% on post mortem studies. There is thought to be a link with another condition of the lower oesophagus called Barrett's oesophagus, although there is limited evidence. Unlike Barrett's oesophagus, progression to cancer from an inlet patch is exceptionally rare.

The inlet patch can produce acid and mucus, and is associated with symptoms including sore throat, cough and hoarseness. One particular symptom, called globus pharyngeus (the feeling of a ball in the back of the throat) is often associated with an inlet patch.

There is no recognised treatment for symptomatic inlet patch. Anti-acid medications works for some but not all, which may in part be explained by the lack of acid producing cells in some inlet patches. Ablation of the inlet patch has been successful in small series using Argon Plasma Coagulation. This device is, however, associated with inter user variability and unpredictable depth of ablation. Radiofrequency ablation (RFA) using the BarrxTM System is a National Institute for Health and Clinical Excellence (NICE) and FDA approved device for treatment of abnormal oesophageal lining, which has shown to be successful in reversing Barrett's oesophagus to normal squamous lining. These devices are advantageous as the depth of ablation is controlled. The investigators have previously demonstrated, in a pilot study, that these devices are safe and effective for reversal of inlet patch to normal mucosa, with improvement in symptoms.

This study will use the BarrxTM system to treat patients with symptomatic inlet patch that is refractory to standard anti-acid medication, in a blinded sham controlled trial. ;

Related Conditions & MeSH terms

• Barrett Esophagus

• NCT number: NCT03471052
• Study type: Interventional
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Jason Dunn
• Phone: 02071887188
• Email: GMSresearch@gstt.nhs.uk
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2018
• Completion date: September 30, 2021