POEM vs Dilatation
Research type
Research Study
Full title
A prospective randomized multi-center study comparing endoscopic pneumodilation and per oral endoscopic myotomy (POEM) as treatment of idiopathic achalasia
IRAS ID
172808
Contact name
Rami Sweis
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 11 months, 30 days
Research summary
Achalasia is a disorder of the gullet (oesophagus) which causes difficulty swallowing, chest pain and regurgitation of food/fluid. The normal coordinated contractions of the oesophagus are lost and the muscle between the stomach and the oesophagus (lower oesophageal sphincter; LOS) does not open easily. Treatment for Achalasia is centred upon opening the passage between the oesophagus and stomach in order to reduce the hold up of food/fluid. The most commonly used treatments for achalasia are Botox injection into the LOS, pneumatic dilatation (PD) of the LOS with a balloon and surgery (Heller’s Myotomy; HM) where the muscles within the LOS are cut. HM is usually combined with an anti-reflux procedure performed at the same time. Botox is used only for those who will not tolerate surgery or dilatation. PD, the most common therapy, is the simplest to organise but normally needs to be repeated on a 6-12 monthly basis however outcomes have been shown to be at least as good as surgery for the first two years. HM has the best outcomes but is ultimately a surgical procedure with well-recognised complications. Also hold up from the anti-reflux procedure can cause problems with swallowing. A new procedure (POEM; per-oral endoscopic myotomy) has been introduced in which the same muscles are cut as in surgery but this is performed through an endoscope; access is achieved through a small cut within the oesophagus rather than through the chest/abdomen. Outcome studies so far have shown that results are at least as good as surgery.
This is a multi-centre multi-national trial in which patients with achalasia who have not had previous treatment are randomised to receive either POEM or PD. The study is designed to evaluate which of the two treatment modalities results in the highest success rate in symptoms and quality-of-life at two years.REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/1636
Date of REC Opinion
29 Sep 2016
REC opinion
Favourable Opinion