RCT of RFA vs sham procedure for symptomatic cervical inlet patch
Research type
Research Study
Full title
Randomised Controlled Trial of radiofrequency ablation versus a sham procedure for symptomatic cervical inlet patch
IRAS ID
216038
Contact name
Jason M Dunn
Contact email
Sponsor organisation
Guy's & St Thomas' NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 3 days
Research 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 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 succesful but limited to a few expert centres. We 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 18yo with previously diagnosed inlet patch causing symtpoms of globus, with > 50% severity on a visual analogue score, are eligible. Three sites, all teaching hospitals with experience in the technique, will recruit within the UK. The study is expected to last 6 months after the last patient is enrolled and treated.REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/2068
Date of REC Opinion
18 Dec 2017
REC opinion
Favourable Opinion