Genco A, Ernesti I, Ienca R, Casella G, Mariani S, Francomano D, Soricelli E, Lorenzo M, Monti M
Department of Surgical Sciences, Surgical Endoscopy Unit, Sapienza University of Rome, Rome, Italy.
Department of Experimental Medicine-Medical Physiopathology, Food Science and Endocrinology Section, Sapienza University of Rome, Rome, Italy.
Obes Surg. 2018 Feb;28(2):405-409. doi: 10.1007/s11695-017-2877-1.
The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy.
The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy.
There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed.
The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.
本研究旨在评估一种无需内镜检查的新型胃内球囊（Elipse™ 球囊，美国马萨诸塞州纳蒂克市 Allurion Technologies 公司）的安全性和有效性。
在荧光透视引导下，连续 38 例患者（女性 28 例，男性 10 例，平均年龄 46.4 ± 10.6 岁，平均体重 109.7 ± 21.9 kg，平均体重指数 (BMI) 38.6 ± 6.7 kg/m²）吞下该球囊。4 个月后，球囊自行排空并通过消化道排出，无需进行上消化道内镜检查。
球囊通过过程中无并发症发生。16 周后，平均体重减轻 12.7 kg，平均超重减轻百分比为 26%，平均 BMI 降低 4.2 kg/m²。总体体重减轻 11.6%。与代谢综合征相关的主要合并症有显著改善：血压（p < 0.02）、腰围（p < 0.002）、甘油三酯（p < 0.0001）、血糖（p < 0.001）和 HOMA-IR 指数（p < 0.001）。治疗结束时，37 个球囊自然随粪便排出，1 个球囊通过内镜取出。
对 38 例连续患者的研究结果表明，Elipse™ 球囊安全、有效，且患者接受度很高。
