Balón intragástrico ingerible Elipse(R). Viabilidad, resultados y requerimientos endoscópicos. Experiencia inicial / Feasibility, results and endoscopic requirements of the Elipse(R) swallowable intragastric balloon: initial experience

Antecedentes: el balón intragástrico Elipse(R) consiste en una cápsula ingerible que se rellena bajo control radiológico. Pasadas 16 semanas, su válvula se degrada, el balón se vacía y se elimina por vía natural, sin endoscopia. El objetivo del estudio es valorar su viabilidad, eficacia, duración, seguridad y requerimientos endoscópicos. Métodos: estudio prospectivo y descriptivo, no aleatorizado, de los primeros pacientes remitidos para Elipse(R). Tras colocación, se realizaba sistemáticamente una radiografía para confirmar su correcto rellenado. Se determinaba la duración del balón en función de su visualización excretado o por radiografía/ecografía. Se recogieron datos de eficacia, tolerancia, efectos adversos y su resolución (requerimientos endoscópicos), así como el grado final de satisfacción a las 16 semanas. Resultados: participaron en el estudio 30 pacientes con peso e índice de masa corporal (IMC) medios basales de 83,3 +/- 10,7 kg y 30,6 +/- 2,7 kg/m². Todos pudieron ingerir la cápsula con correcto control radiológico. A los cuatro meses presentaban una pérdida media de 11,2 +/- 5,5 kg (12,1 +/- 5,8% de pérdida total de peso [PTP], 64,7 +/- 25% de pérdida del exceso de peso [PEP]), con pérdida de peso > 10% en el 80% de pacientes (p < 0,05). Obtuvimos una eliminación precoz del balón con duración insuficiente (< 12 semanas) en 2/24 pacientes (8,3%). La tolerancia fue aceptable en el 80%. Efectos adversos: un vómito del balón, una intolerancia (extracción por gastroscopia) y una oclusión ileal (extracción por ileoscopia). El grado final de satisfacción fue bueno en el 60%. Conclusiones: la implantación del balón Elipse(R) mediante radiología parece viable y segura. A pesar de que algunos balones presentan una duración inferior a la estimable (< 16 semanas en el 29%, incluyendo < 12 semanas en el 8,3%), se obtuvo una aceptable pérdida de peso a los cuatro meses. Existen efectos adversos que requieren endoscopia, por lo que aconsejamos que sea supervisado por un endoscopista bariátrico

Background: the Elipse(R) 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

Feasibility, results and endoscopic requirements of the Elipse® swallowable intragastric balloon: initial experience.

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.