Lopez Nava Gontrand, Arau Roman Turro, Asokkumar Ravishankar, Maselli Daniel B, Rapaka Babusai, Matar Reem, Bautista Inmaculada, Espinos Perez Jorge Carlos, Bilbao Alfredo Mata, Jaruvongvanich Veeravich, Vargas Eric J, Storm Andrew C, Neto Manoel Galvao, Abu Dayyeh Barham K
Bariatric Endoscopy Unit, HM Sanchinarro Hospital, Madrid, Spain.
Teknon Medical Center, Barcelona, Spain.
Clin Gastroenterol Hepatol. 2023 Jan;21(1):81-89.e4. doi: 10.1016/j.cgh.2022.04.019. Epub 2022 May 6.
BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity.
Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration.
44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred.
POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings.
gov Identifier: NCT03721731.
原发性肥胖症手术腔内治疗（POSE）2.0手术采用一种新型的胃体全层折叠方式，使用耐用的缝合锚钉对来缩短和变窄胃部。我们的前瞻性多中心试验研究了POSE 2.0在肥胖成人中的安全性、有效性、持久性和生理效应。
肥胖成人在3个中心接受POSE 2.0手术。主要结局指标为12个月时的总体重减轻百分比（%TBWL）以及体重减轻超过5%TBWL的患者比例。次要结局指标包括肥胖合并症的变化、饱腹感、6个月时的生活质量以及12个月和24个月时折叠的持久性。在整个研究期间对受试者进行不良事件随访。
共纳入44例患者（61%为女性；平均年龄45±9.7岁；平均体重指数37±2.1kg/m²）。该手术平均使用19对缝合锚钉，平均持续时间为37±11分钟，所有受试者手术技术均成功。12个月时的平均%TBWL为15.7%±6.8%。12个月时，分别有98%、86%和58%的患者%TBWL>5%、>10%和>15%。6个月时血脂、肝脏生化指标和肝脂肪变性有所改善。在一部分患者中，肝脂肪变性的改善持续了24个月（P<.01）。POSE 2.0降低了最大耐受进餐量（P=.03），并与6个月时饱腹感增加（P<.01）和进食行为改善（P<.01）相关。体重对生活质量问卷的影响在6个月时有所改善（2.23对1.23；P<.01）。24个月时（n=26）的重复评估显示折叠完全完整。未发生严重不良事件。
POSE 2.0是一种有效且持久的内镜减肥治疗方法，可能会影响影响饱腹感的生理途径。需要进行更大规模的比较研究来进一步阐明这些初步发现。
美国国立医学图书馆临床试验注册中心标识符：NCT03721731
