Background

Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone.

Methods

We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21–65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m². Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks.

Findings

Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery.

Interpretation

ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975.

Funding

Apollo Endosurgery, Mayo Clinic.

中文翻译：

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内窥镜袖状胃成形术治疗 1 级和 2 级肥胖症 (MERIT)：一项前瞻性、多中心、随机试验

背景

内窥镜袖状胃成形术 (ESG) 是一种用于治疗肥胖的腔内、保留器官的疗法，在全球范围内得到广泛采用。我们旨在探索 ESG 与生活方式改变相比的有效性和安全性。

方法

我们在美国的九个中心进行了一项随机临床试验，招募了年龄在 21-65 岁的 1 级或 2 级肥胖并同意遵守终身饮食限制的个体。参与者在 52 周时被随机分配（1:1·5；分层排列块）到 ESG 与生活方式改变（ESG 组）或仅生活方式改变（对照组），分别可能重新收紧或交叉到 ESG。生活方式的改变包括低热量饮食和体育锻炼。对主要 ESG 组的参与者进行了 104 周的随访。52 周时的主要终点是超重减轻 (EWL) 的百分比，超重是指 BMI 为 25 kg/m ^{2时超过理想体重的百分比}. 次要终点包括组间代谢合并症的变化。我们使用具有混合效应模型的多个估算意向治疗分析。我们的分析是在符合方案的基础上和改良的意向治疗基础上进行的。安全人群定义为接受 ESG（主要和交叉 ESG）长达 52 周的所有参与者。

发现

在 2017 年 12 月 20 日至 2019 年 6 月 14 日期间，209 名参与者被随机分配到 ESG（n=85）或对照组（n=124）。在 52 周时，ESG 组的主要终点 EWL 平均百分比为 49·2% (SD 32·0)，对照组为 3·2% (18·6) (p<0·0001)。ESG 组的平均总体重减轻百分比为 13·6% (8·0)，对照组为 0·8% (5·0) (p<0·0001)，77 人中有 59 (77%) ESG 组的参与者在 52 周时达到 25% 或更多的 EWL，而对照组 110 名参与者中有 13 名 (12%) (p<0·0001)。在 52 周时，ESG 组 51 名参与者中有 41 名 (80%) 的一种或多种代谢合并症得到改善，而 6 名 (12%) 则恶化，而对照组 62 名参与者中有 28 名 (45%) 有类似的改善，而 31 (50%) 恶化。在 104 周时，ESG 组 60 名参与者中有 41 名 (68%) 维持 25% 或更多的 EWL。131 名参与者中有 3 名 (2%) 发生了 ESG 相关的严重不良事件，没有死亡或需要重症监护或手术。

解释

ESG 是一种安全干预措施，可显着减轻体重，维持在 104 周，并显着改善代谢合并症。ESG 应被视为 1 级或 2 级肥胖患者的协同减重干预措施。该试验已在 ClinicalTrials.gov 注册，NCT03406975。

资金

阿波罗内窥镜手术，梅奥诊所。