Endoscopic sleeve gastroplasty (ESG) was considered a "safe and effective" option for the NHS to treat people with obesity with a BMI over 30, who have not lost weight with lifestyle modification alone, and are not suitable or did not wish to undergo bariatric surgery.
In draft guidance, the National Institute for Health and Care Excellence (NICE) acknowledged a "growing unmet need" for obesity treatments, and that said an evidence review showed ESG, which reduces the size of the stomach by two-thirds, was safe in both the short and long term when combined with lifestyle changes.
Minimally Invasive Alternative to Bariatric Surgery
The regulator described the procedure as "minimally invasive" and said it could offer people an alternative to bariatric surgery, which is recommended only at higher BMI thresholds (in general at a BMI of 40 or over, or lower in people with comorbidities such as type 2 diabetes or in people of Asian family background).
"ESG is an additional endoscopic treatment option and can be used at an earlier stage in the treatment pathway to reduce the risk of progression," NICE stated. It involves using a double channel transoral endoscope with a procedure-specific endoscopic device attached to create a series of endoluminal full-thickness suture plications along the greater curvature of the stomach. This folds and stitches together sections of the stomach wall to create a tube-like sleeve, reducing stomach volume by about 70% to 80%, and perhaps delaying gastric emptying.
There is no resection of the stomach and the procedure may be reversible. It takes up to 90 minutes to complete, and although carried out under general anaesthetic, patients can usually go home on the same day, although most are kept overnight under observation.
NICE said that clinical trials showed 59 (77%) of 77 participants lost 25% or more of their original weight a year after having the procedure. Although not as effective as sleeve gastrectomy or laparoscopic sleeve gastroplasty on direct comparison, percentage total weight loss was significantly higher with ESG than with intensive lifestyle modification alone (13.6% compared with 0.8%, p<0.0001), and significantly higher than with intragastric balloons.
Most Adverse Reactions Can Be Managed Conservatively
In trials, the overall pooled rate of adverse events was 2.3%, with rates of 1.5% for mild, 1.7% for moderate, and 0.8% for severe adverse events, with no procedure-related mortality reported in any of the included studies. The most common major adverse events were gastrointestinal bleeding and perigastric fluid collection, and most events could be managed conservatively.
Minor adverse events reported included nausea or vomiting (managed with medications) in 25%, epigastric pain (beyond 24 hours, managed with medicines) in 31%, and constipation (managed with laxatives) in 29%.
The committee recommended that the procedure be carried out only in specialist centres by clinicians with specific training and experience, and in patients selected by a multidisciplinary team experienced in managing obesity. All patient details should be submitted into the National Bariatric Surgery Registry.
ESG "A Welcome New Option"
Professor Jonathan Benger, chief medical officer at NICE, said: "Our committee has found endoscopic sleeve gastroplasty for people living with obesity to be a safe and effective procedure." He pointed out that people with obesity were at risk of type 2 diabetes, hypertension, and cardiovascular disease, so a procedure that helped to reduce weight also lowered the risk of these other conditions and improved overall health and wellbeing.
"Surgical treatment options are in high demand and not everyone wants, or is fit enough, to undergo an operation like bariatric surgery. A non-invasive procedure like endoscopic sleeve gastroplasty could be a welcomed new option for some people," said Professor Benger. He added: "One of the benefits is that this procedure can be carried out as a day case... reducing the time people spend in hospital compared with other surgical options. Recovery is also quicker."
The Health Survey for England 2021 estimated that 25.9% of adults in England were obese and a further 37.9% overweight. Obesity costs the NHS around £6.5 billion a year and is the second biggest preventable cause of cancer.
A 4-week consultation on the draft recommendations closes on 26 October 2023 and final guidance is expected to be published on 22 February 2024.
Although NICE is an England-only body, agreements are in place with the devolved administrations of Scotland, Wales, and Northern Ireland to adopt interventional procedures guidance.