Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial

Dayyeh, Barham K. Abu; Bazerbachi, Fateh; Vargas, Eric J.; Sharaiha, Reem Z.; Thompson, Christopher C.; Thaemert, Bradley C; Teixeira, André; Chapman, Christopher G.; Kumbhari, Vivek; Ujiki, Michael; Ahrens, Jeanette E.; Day, Courtney N.; Neto, Manoel Galvão; Zundel, Natán; Wilson, Erik B.; Acosta, Andrés; Badurdeen, Dilhana; Buttar, Navtej; Clark, Matthew M.; Eaton, Laura; Ghanem, Omar M.; Grothe, Karen; Jirapinyo, Pichamol; Kellogg, Todd; Klein, Connie; Mundi, Manpreet S.; Storm, Andrew C.; Rivera, Angielyn; Wilson, Todd

doi:10.1016/s0140-6736(22)01280-6

Cited by 183 publications

(112 citation statements)

References 28 publications

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“…Table 4 shows the results of the drinking satiety test for the three different time points (baseline and months 6 and 12). The feeling of satiety using a 0–10 visual scale was 8 (5–9), 7 (7–8), and 8 (5–8) for groups A, B, and C, respectively and was less intense in all three groups (4.5 1 2 3 4 5 6 7 8 , 6 2 3 4 5 6 7 8 , and 6.5 [2.5–8.5]) for groups A, B, and C, respectively) at the end of follow-up. There was no difference among the three groups regarding the satiety test at the end of follow-up ( P = 0.933).…”

Section: Resultsmentioning

confidence: 99%

“…Overstitch has been the most frequently performed procedure for treating class I and II obesity with good results reported in post-marketing retrospective studies, while a systematic review and meta-analysis of eight (retrospective) studies concluded that ESG using the Overstitch system may lead to a 15.6 % total body weight loss (TBWL) at 12 months post-procedure 4 5 . The results of a randomized clinical trial (RCT) recently have been announced with a 49 % EWL at 12 months, two times higher than lifestyle therapy alone in controls 6 .…”

Section: Introductionmentioning

confidence: 99%

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Weight loss after endoscopic sleeve gastroplasty is independent of suture pattern: results from a randomized controlled trial

et al. 2022

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Background and study aims: Single-blind, single-center prospective randomized trial aiming to compare the efficacy of three different suturing patterns of endoscopic sleeve gastroplasty using Endomina (E-ESG). Materials and methods: The suture patterns aimed to modify gastric accommodation by increasing the fundus distention ability (group A), to reduce gastric volume (group B) or to interrupt gastric emptying (group C). Patients were 1:1:1 randomized and underwent clinical follow-up, gastric emptying scintigraphy and satiety tests at baseline, 6, and 12 months post-procedure. The primary outcome was total body weight loss (TBWL) and excess weight loss (EWL) at 12 months post-procedure. Secondary outcomes included the impact of the suturing patterns on gastric emptying and satiety. Results: Overall, 48 patients (40 [83.3%] female, age 41.9±9.5 years, BMI 33.8±2.7 kg/m2) were randomized (16 in each group). In the entire cohort, mean (95%CI) TBWL and EWL at the end of the follow-up were 10.11% (7.1-13.12) and 42.56 (28.23-56.9), respectively. There was no difference among the three study groups in terms of TBWL (95%CI) (9.13% [2.16-16.11] vs. 11.29% [5.79-16.80] vs. 9.96% [4.58-15.35]; p=0.589) and EWL (95%CI) (34.54% [6.09-62.99] vs. 44.75% [23.63-65.88] vs. 46.94% [16.72-77.15]; p=0.888) at 12 months post-procedure. The three groups did not differ in terms of mean gastric emptying time or in terms of satiety tests at the end of the follow-up. No serious adverse events occurred. Conclusions: Three different suture patterns during E-ESG demonstrated comparable efficacy in terms of weight loss, with an overall EWL of >25% and TBWL of >10% at 12 months.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Weight loss after endoscopic sleeve gastroplasty is independent of suture pattern: results from a randomized controlled trial

et al. 2022

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“…In a priori - designed single-centre nested substudy of a multicentre US randomised controlled clinical trial (MERIT trial), we evaluated the effects of the ESG versus moderate-intensity LS on GE of solids, weight loss, GI hormones and eating habits 17. The main study participants were allocated in a 1:1.5 fashion using computer-generated variable block randomisation stratified by hypertension and type 2 diabetes.…”

Section: Methodsmentioning

confidence: 99%

Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study

Vargas

Rizk

Gomez-Villa

et al. 2022

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ObjectiveEndoscopic sleeve gastroplasty (ESG) has gained global adoption but our understanding of its mechanism(s) of action and durability of efficacy is limited. We sought to determine changes in gastric emptying (GE), gastric motility (GM), hormones and eating behaviours after ESG.DesignA priori-designed single-centre substudy of a large US randomised clinical trial, adults with obesity were randomised to ESG or lifestyle interventions (LS) alone. We measured GE, hormones and weight loss and assessed eating behaviours. In a subset of ESG patients, we assessed GM. The primary outcome was the change in T1/2(min) at 3 months, and secondary outcomes were changes in weight, GE, GM, hormones and eating behaviours. We used t-test analyses and regression to determine the association between GE and weight loss.Results36 (ESG=18; LS=18) participated in this substudy. Baseline characteristics were similar between the two groups. At 3 months, T1/2was delayed in the ESG group (n=17) compared with the LS group (n=17) (152.3±47.3 vs 89.1±27.9; p<0.001). At 12 months, T1/2remained delayed in the ESG group (n=16) vs control group (n=14) (137±37.4 vs 90.1±23.4; p<0.001). Greater delays in GE at 3 months were associated with greater weight loss. GM was preserved and fasting ghrelin, glucagon-like peptide 1 and polypeptide YY significantly increased 18 months after ESG.ConclusionESG promotes weight loss through several key mechanistic pathways involving GE and hormones while preserving GM. These findings further support clinical adoption of this technique for the management of obesity.Trial registration numberNCT03406975.

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“…-Despite the high prevalence of NAFLD in Europe, no effective pharmacological treatment is currently approved for use -Existing therapies mainly focus on metabolic disorders associated with NAFLD 26,27 Endoscopic and metabolic therapies -Patients with obesity who receive intragastric balloons or endoscopic sleeve gastroplasty and lifestyle intervention show a higher mean total bodyweight loss compared to those who receive lifestyle intervention only 28,29 The role of bariatric surgery -Bariatric surgery should be considered in patients with morbid obesity -Bariatric surgery is associated with greater and faster weight loss and, in most cases, with improved long-term results compared with conventional therapy. This has the potential to reduce all-cause mortality and the development of obesity-related…”

Section: Pharmacological Therapiesmentioning

confidence: 99%

UEG position paper: Obesity and digestive health

et al. 2022

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Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial

Cited by 183 publications

References 28 publications

Weight loss after endoscopic sleeve gastroplasty is independent of suture pattern: results from a randomized controlled trial

Weight loss after endoscopic sleeve gastroplasty is independent of suture pattern: results from a randomized controlled trial

Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study

UEG position paper: Obesity and digestive health

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