Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
CentraCare, Interventional Endoscopy Program, St Cloud Hospital, St Cloud, MN, USA.
Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.
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.
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/m. 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.
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.
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.
Apollo Endosurgery, Mayo Clinic.
内镜袖状胃成形术（ESG）是一种针对肥胖症的内镜、保留器官的治疗方法，在全球范围内得到广泛应用。我们旨在探讨 ESG 联合生活方式改变与单纯生活方式改变相比的疗效和安全性。
我们在 9 个美国中心进行了一项随机临床试验，纳入年龄在 21-65 岁之间、患有 1 类或 2 类肥胖症且同意遵守终身饮食限制的个体。参与者被随机分配（1:1.5；分层随机分组）到 ESG 联合生活方式改变（ESG 组）或单纯生活方式改变（对照组），分别在 52 周时进行潜在的重新收紧或交叉到 ESG。生活方式改变包括低热量饮食和体育活动。主要 ESG 组的参与者随访 104 周。主要终点是 52 周时的超重体重减轻百分比（EWL），超重是指 BMI 为 25 kg/m 时超过理想体重的体重。次要终点包括两组之间代谢合并症的变化。我们使用了基于混合效应模型的多重插补意向治疗分析。我们的分析基于方案和修改后的意向治疗。安全人群定义为所有接受 ESG（包括主要和交叉 ESG）至 52 周的参与者。
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 组（n=85）或对照组（n=124）。在 52 周时，ESG 组的平均 EWL 百分比为 49.2%（SD 32.0），对照组为 3.2%（18.6）（p<0.0001）。ESG 组的平均体重减轻百分比为 13.6%（8.0），对照组为 0.8%（5.0）（p<0.0001），59 名（77%）的 77 名 ESG 组参与者在 52 周时达到了 25%或更多的 EWL，而对照组的 110 名参与者中只有 13 名（12%）达到了（p<0.0001）。在 52 周时，51 名 ESG 组参与者中有 41 名（80%）的一种或多种代谢合并症得到改善，而 6 名（12%）恶化，而对照组中 62 名参与者中有 28 名（45%）有类似的改善，而 31 名（50%）恶化。在 104 周时，60 名 ESG 组参与者中有 41 名（68%）保持了 25%或更多的 EWL。ESG 相关的严重不良事件发生在 131 名参与者中的 3 名（2%），无死亡或需要重症监护或手术。
ESG 是一种安全的干预措施，可导致显著的体重减轻，并在 104 周时保持，对代谢合并症有重要的改善。ESG 应被视为 1 类或 2 类肥胖症患者的协同减重干预措施。这项试验在 ClinicalTrials.gov 注册，编号为 NCT03406975。
Apollo Endosurgery，Mayo Clinic。
