EndoSTIM for GORD in asthma
Research type
Research Study
Full title
Laparoscopic EndoSTIM electrical stimulation system of the lower oesophageal sphincter for the treatment of gastro-oesophageal reflux disease (GORD) in asthma – a pilot, randomised, sham-controlled study
IRAS ID
180707
Contact name
Tim Underwood
Contact email
Duration of Study in the UK
2 years, 6 months, 3 days
Research summary
Asthma is a common, chronic and debilitating disease with a very wide health and socioeconomic burden. There is a significant asthmatic population which doesn’t respond as expected to the standard available treatment for asthma and that generates the need for defining phenotypes that need to be robustly identified and managed in a more fit for purpose way with good quality evidence.
Gastrooesophageal reflux disease (GORD) affects a large population and is a suspected trigger in a significant proportion of asthmatics. We hypothesise that gastrooesophageal reflux (GOR) triggers inflammation in the upper and lower respiratory tract. This inflammation is a response to acid as well as weak acid and nonacidic components of the refluxate. A result of multiple mechanisms, this inflammation leads to resistance to standard asthma treatment. We aim to investigate the impact of GOR on the respiratory system and evaluate the response of asthma to treatment of GORD with lower oesophageal electrical stimulation with EndoSTIM.
Our study based at Southampton Hospital will identify asthmatics with GOR using quantitative and qualitative assessment of reflux and the resultant airway inflammation and its pathophysiological impact. This will be done with a combination of lung functions, 24 hour pH/Impedance monitoring, sputum and breath analysis. The process will then be repeated after treatment of reflux with electrical stimulation of the lower oesophageal sphincter with the EndoSTIM device inserted into selected participants with laparoscopic guidance under general anaesthesia. pH/impedance monitoring will be repeated after the procedure to assess and establish the response to treatment.
Ultimately, this programme of research should help select patients with significant GOR with or without any associated condition, for focussed treatment such as with EndoSTIM, which physically prevents reflux and can thus deal with both acid and non-acid reflux against which PPIs and other anti-reflux medication may be ineffective.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
15/SC/0403
Date of REC Opinion
3 Sep 2015
REC opinion
Further Information Favourable Opinion