Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA.
Surg Obes Relat Dis. 2012 May-Jun;8(3):296-303. doi: 10.1016/j.soard.2011.10.016. Epub 2011 Nov 9.
The aim of the present pilot study was to evaluate the safety and weight loss efficacy of endoscopic transoral gastric volume reduction using an endoscopic suturing system.
Patients with a body mass index (BMI) of 30-45 kg/m(2) were enrolled in the present institutional review board-approved study. Anterior to posterior gastric plications were placed in the gastric fundus and body using the suturing device. The endpoints were procedure time, adverse events, weight loss, and endoscopic findings at 1, 6, and 12 months after the procedure. The nominal P values are presented.
A total of 18 patients underwent the procedure (9 at each site). The mean age and BMI was 40 years and 38 kg/m(2), respectively. The average number of plications placed per patient was 6, and the mean procedure time was 2.1 hours (range 1.5-2.8). At 12 months of follow-up (n = 14), decreases in the mean weight (-11.0 ± 10.0 kg, P = .0006), mean BMI (-4.0 ± 3.5 kg/m(2), P = .0006), and mean waist circumference (-12.6 ± 9.5 cm, P = .0004) were observed. The mean excess weight loss at 12 months was 27.7% ± 21.9%. The proportion of patients with an EWL of ≥ 20% or ≥ 30% was 57% and 50%, respectively. The mean systolic and diastolic blood pressure decreased by 15.2 mm Hg (P = .0012) and 9.7 mm Hg (P = .0051), respectively. No device- or procedure-related serious adverse events. Endoscopy at 12 months of follow-up showed partial or complete release of plications in 13 patients.
Transoral gastric volume reduction procedure using the RESTORe Suturing System device proved to be safe and well tolerated. Procedural technical success was achieved for all subjects. Modest decreases in weight, BMI, and waist circumference were observed, as was a decline in the frequency of hypertension. Despite some overall positive clinical findings, the plications were not durable, and the effects of the procedure varied widely among the study participants. Additional research is needed to provide a more reproducible and durable effect.
本初步研究旨在评估使用内镜缝合系统经口内镜下胃容积减少术的安全性和减重效果。
本机构审查委员会批准的研究纳入了身体质量指数（BMI）为 30-45kg/m²的患者。在胃底和胃体前壁使用缝合装置进行前后胃折叠。研究终点为手术时间、不良事件、减重效果以及术后 1、6 和 12 个月的内镜发现。列出了名义 P 值。
共有 18 例患者（每个部位 9 例）接受了该手术。患者的平均年龄和 BMI 分别为 40 岁和 38kg/m²。平均每位患者的折叠数量为 6 个，手术时间平均为 2.1 小时（范围 1.5-2.8 小时）。在 12 个月的随访中（n=14），患者体重（-11.0±10.0kg，P=0.0006）、BMI（-4.0±3.5kg/m²，P=0.0006）和腰围（-12.6±9.5cm，P=0.0004）均有下降。12 个月时的平均超重减轻量为 27.7%±21.9%。EWL≥20%或≥30%的患者比例分别为 57%和 50%。平均收缩压和舒张压分别下降 15.2mmHg（P=0.0012）和 9.7mmHg（P=0.0051）。无器械或手术相关严重不良事件。12 个月时的内镜检查显示 13 例患者的折叠部分或完全松解。
使用 RESTORe 缝合系统装置进行经口胃容积减少术安全且耐受良好。所有患者均达到手术技术上的成功。体重、BMI 和腰围均有适度下降，高血压的发生频率也有所下降。尽管临床总体发现较为积极，但折叠效果并不持久，且手术效果在研究参与者之间差异较大。需要进一步研究以提供更具可重复性和持久性的效果。
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