Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia, USA.
Division of General and Gastrointestinal Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.
Obesity (Silver Spring). 2019 Aug;27(8):1255-1265. doi: 10.1002/oby.22523.
This study evaluated the safety of percutaneous CT-guided cryoablation of the vagus nerve (percutaneous cryovagotomy) in participants with class I or class II obesity.
The study was an open-label, single-group, prospective pilot investigation designed around safety-related stopping criteria. Twenty participants with 30 > BMI > 37 underwent percutaneous cryovagotomy with follow-up visits at day 7, 45, 90, and 180. Data related to adverse events, technical success, weight loss, quality of life, dietary intake, global impressions of hunger change, activity, and body composition were analyzed.
The procedural technical success rate was 100%. There were no adverse events in 19 participants who completed the trial. Ninety-five percent of patients reported decreased appetite following the procedure, and reductions in mean absolute weight and BMI were observed at all time points. The mean quality of life and activity scores improved from baseline to 6 months post procedure, and mean caloric intake and overall body fat decreased over the same period.
Percutaneous CT-guided cryovagotomy is feasible and was tolerated without complications or adverse events in this cohort. Quantitative preliminary data from this pilot investigation inform the design of a larger prospective randomized clinical trial.
本研究评估了经皮 CT 引导下的迷走神经冷冻消融术（经皮冷冻神经切断术）在 I 类或 II 类肥胖患者中的安全性。
本研究为开放性、单组、前瞻性试点研究，围绕安全性相关的停止标准设计。20 名 BMI 大于 30 且小于 37 的参与者接受了经皮冷冻神经切断术，并在第 7、45、90 和 180 天进行随访。分析与不良事件、技术成功率、体重减轻、生活质量、饮食摄入、饥饿感变化的总体印象、活动和身体成分相关的数据。
手术的技术成功率为 100%。19 名完成试验的参与者均未出现不良事件。95%的患者在手术后报告食欲下降，并且在所有时间点均观察到平均绝对体重和 BMI 的降低。与基线相比，术后 6 个月的生活质量和活动评分有所改善，同期的热量摄入和总体体脂减少。
在本队列中，经皮 CT 引导下的冷冻神经切断术是可行的，且耐受良好，无并发症或不良事件。来自该试点研究的定量初步数据为更大规模的前瞻性随机临床试验设计提供了信息。
