Aparato Digestivo, Gastrodex. Hospital Universitario Quiron Dexeus, España.
Aparato Digestivo. Endoscopia digestiva-bariátrica, Gastrodex. Hospital Universitario Dexeus.
Rev Esp Enferm Dig. 2019 Dec;111(12):921-926. doi: 10.17235/reed.2019.6340/2019.
the Elipse® intragastric balloon (EIGB) is a swallowable capsule that is filled under x-ray control. After 16 weeks, its self-releasing valve is degraded and the balloon is deflated and excreted naturally, without endoscopy. The aim of this study was to assess the feasibility of EIGB and its efficacy, duration, safety and endoscopic requirements.
this is a prospective, descriptive, non-randomized study of the first patients enrolled for EIGB. An x-ray was systematically performed after placement to ensure the correct filling of the balloon. The balloon duration was determined according to its excreted visualization or by x-ray/ultrasound. The efficacy, tolerance, adverse events and their resolution outcome (endoscopic requirements), as well as the final satisfaction degree at 16 weeks, were analyzed.
the study included 30 patients with a basal mean weight and body mass index (BMI) of 83.3 ± 10.7 kg and 30.6 ± 2.7 kg/m². All subjects swallowed the capsule with correct x-ray control. The mean weight loss was 11.2 ± 5.5 kg (12.1 ± 5.8% of total weight loss [TWL], 64.7 ± 25% of excess weight loss [EWL]), with a weight loss > 10% in 80% of patients (p < 0.05) after four months. Early elimination of the balloon with an insufficient duration (< 12 weeks) was observed in 2/24 patients (8.3%). There was an acceptable tolerance in 80%. With regard to adverse effects, one balloon was vomited up, there was one intolerance and the balloon was removed by gastroscopy and one small bowel ileal obstruction, which was removed by ileoscopy. The final satisfaction degree was good in 60% of cases.
EIGB placement by x-ray seems feasible and safe. Although some devices have a shorter duration than expected, such as < 16 weeks in 29% patients and < 12 weeks in 8.3% of patients, an acceptable weight loss at four months was obtained. There were some adverse effects that required endoscopy, thus we advise that the procedure be supervised by a bariatric endoscopist.
Elipse® 胃内球囊（EIGB）是一种可吞咽胶囊，在 X 光控制下填充。16 周后，其自释放阀降解，球囊自然瘪缩并排出，无需内镜检查。本研究旨在评估 EIGB 的可行性及其疗效、持续时间、安全性和内镜要求。
这是一项前瞻性、描述性、非随机的 EIGB 首批入组患者研究。球囊放置后系统行 X 线检查以确保球囊正确填充。根据球囊排出的可视化或 X 线/超声确定球囊持续时间。分析疗效、耐受性、不良事件及其解决结果（内镜要求）以及 16 周时的最终满意度。
研究纳入 30 例患者，基础平均体重和体重指数（BMI）为 83.3 ± 10.7kg 和 30.6 ± 2.7kg/m²。所有患者均在 X 光控制下吞服胶囊。平均体重减轻 11.2 ± 5.5kg（总体重减轻的 12.1 ± 5.8%，多余体重减轻的 64.7 ± 25%），4 个月后 80%的患者体重减轻>10%（p<0.05）。24 例中有 2 例（8.3%）球囊过早排出（持续时间<12 周）。80%的患者耐受性可接受。关于不良事件，1 例球囊呕吐，1 例不耐受，球囊通过胃镜取出，1 例小肠回肠梗阻，通过回肠镜取出。最终满意度为 60%。
X 光引导下放置 EIGB 似乎是可行且安全的。尽管一些装置的持续时间短于预期，如 29%的患者<16 周和 8.3%的患者<12 周，但在 4 个月时获得了可接受的体重减轻。有些不良事件需要内镜处理，因此我们建议该操作由减重内镜医生进行监护。
