A pilot study investigating the safety and feasibility of embolising the left gastric artery to aid rapid weight-loss in morbidly obese patients awaiting elective surgery.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000095864

Acronym

POWER SLIM

Enrollment

Registered

2021-02-01

Start date

2021-07-13

Completion date

2021-07-13

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot study will assess if blocking the blood supply to part of the stomach (known as a left gastric artery embolisation procedure) is feasible and can be performed safely in a small group of obese patients who are awaiting elective surgery. Blocking up the blood supply to a portion of the stomach reduces the production of the hormone that stimulates appetite (called ghrelin). Lower ghrelin levels in the blood stream have been shown to reduce the "hunger drive" and consequently reduce calories consumed, making dieting more effective and speeding up weight-loss. It is common for elective surgery in obese people to be delayed until they lose weight, and this procedure may help these patients to reach their weight-loss goals earlier. This study may provide information necessary to complete larger studies assessing the effectiveness of left gastric artery embolisaton as a complimentary weight loss technique.

Interventions

Gastric artery embolisation (GAE). Embolisation of gastrointestinal arteries is a safe and effective procedure that has been performed by interventional radiologists for many years to manage intractable GI bleeding. Although GAE is currently performed for intractable gastric bleeding, indication for this project is unique, being a method to modulate hormones, suppress appetite and accelerate weight loss. The embolisation procedure will be performed by an interventional radiologist. This involves accessing an artery in the wrist to selectively occlude the left gastric artery with microscopic spherical embolic particles while the patient is under general anesthetic. This is a one time procedure and will take <60 minutes.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

BMI over 35 and weight <200 kg awaiting elective surgery, non-bariatric operative candidates; adequate renal, hepatic and haematologic function; able to undergo an angiographic procedure; medically fit enough to undertake mild or moderate exercise, motivated to lose weight and adhere to prescribed dietary advice. Further, patients must have private health insurance to be included in this trial.

Exclusion criteria

Malignancy; pregnancy; active H. pylori infection; autoimmune disease; history of inflammatory bowel disease; eGFR <35; allergy to intravenous contrast; severe cardiopulmonary dysfunction; serious mental health or mood modulating medication; previous oesophageal or gastric surgery; planned or interest in future bariatric surgery.

Outcome results