EMBIO Trial
Research type
Research Study
Full title
Left gastric artery embolisation for weight loss in obese patients with BMI 35-50kg/m2: EMBIO trial
IRAS ID
247521
Contact name
Ahmed Ahmed
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Obesity is a major health issue. The most effective treatment we have is surgery, which is not suitable for all patients. There is a great need to develop new treatments which are less invasive and more cost-effective.
Recent studies have shown that if using a procedure called left gastric artery embolisation (LGAE), the blood supply to the top of the stomach (gastric fundus) can be reduced, and this results in a drop in the level of an appetite stimulating hormone called Ghrelin. LGAE is usually performed using local anaesthetic and often takes less than 1 hour, with a short 4 hour observation period afterwards. This embolisation procedure has been done safely for the last 4 decades as a treatment for bleeding stomach ulcers. Indeed, it has been shown that patients having stomach embolisations for bleeding stomach ulcers lose more weight than patients having embolisations to other organs or other areas of the stomach.
In order to investigate whether this could be an effective and safe technique to help with weight loss, we propose to study obese patients in a randomised controlled trial where patients undergoing embolisation are compared to those undergoing a "placebo" procedure. The latter involves going through the procedure up to the point when the hydrophilic sheath is placed into the radial artery. No further interventions will be performed following sheath insertion, but as far as possible the procedure will mimic the actions and experience of the LGAE arm. The trial participants and all the staff except the operating team will be blinded to the treatment allocation.
We will also ask trial participants to come in for some study visits, where we will assess underlying physiological changes in response to LGAE. The trial participants will be followed up on a regular basis for 12 months.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/0509
Date of REC Opinion
14 Oct 2019
REC opinion
Further Information Favourable Opinion