Year 2019 / Volume 111 / Number 12
Original
Feasibility, results and endoscopic requirements of the Elipse® swallowable intragastric balloon: initial experience

921-926

DOI: 10.17235/reed.2019.6340/2019

Eduardo Espinet Coll, Sonia Carrasco Clavijos, Patricia Díaz Galán, Carmen Vila Lolo, José Antonio Gómez Valero, Silvia Bacchiddu, Daniel Irigoyen, Teresa Durán Pastor, Laura Mora Cubells, Antonio Juan-Creix Comamala,

Abstract
Background: 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. Methods: 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. Results: 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. Conclusions: 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.
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Espinet Coll E, Carrasco Clavijos S, Díaz Galán P, Vila Lolo C, Gómez Valero J, Bacchiddu S, et all. Feasibility, results and endoscopic requirements of the Elipse® swallowable intragastric balloon: initial experience. 6340/2019


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Publication history

Received: 16/04/2019

Accepted: 07/06/2019

Online First: 10/10/2019

Published: 05/12/2019

Article revision time: 45 days

Article Online First time: 177 days

Article editing time: 233 days


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