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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References
1. Moura D, Oliveira J, De Moura EG, et al. .Effectiveness of intragastric balloon for obesity: A systematic review and meta-analysis based on randomized control trials. Surg Obes Relat Dis 2016; 12(2): 420-9.
2. Neto MG, Silva LB, Grecco E, et al. Brazilian Intragastric Balloon Consensus Statement (BIBC): practical guidelines based on experience of over 40,000 cases. Surg Obes Relat Dis. 2018 Feb;14(2):151-159. doi: 10.1016/j.soard.2017.09.528. Epub 2017 Sep 28.
3. Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, et al. Spanish Consensus Document on Bariatric Endoscopy. Part 1: general considerations. Rev Esp Enferm Dig. 2018 Jun;110(6):386-399. doi: 10.17235/reed.2018.4503/2016.
4. Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, et al. Spanish Consensus Document on Bariatric Endoscopy. Part 2: specific endoscopic treatments. Rev Esp Enferm Dig. 2019 Feb;111(2):140-154. doi: 10.17235/reed.2019.4922/2017.
5. Raftopoulos I, Giannakou A. The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12-month outcomes. Surg Obes Relat Dis. 2017 Jul;13(7):1174-1182. doi: 10.1016/j.soard.2017.02.016. Epub 2017 Feb 21.
6. Machytka E, Gaur S, Chuttani R, et al. Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy. 2017 Feb;49(2):154-160. doi: 10.1055/s-0042-119296. Epub 2016 Dec 12
7. Machytka E, Chuttani R, Bojkova M, et al. Elipse, a procedureless gastric balloon for weight loss: a proof-of-concept pilot study. Obes Surg. 2016;26 (3):512-16.
8. Nunes GC, Pajecki D, de Melo ME, et al. Assessment of Weight Loss With the Intragastric Balloon in Patients With Different Degrees of Obesity. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):e83-e86. doi: 10.1097/SLE.0000000000000440.
9. Hogan RB, Johnston JH, Long BW, et al. A double-blind, randomized, sham-controlled trial of the gastric bubble for obesity. Gastrointest Endosc 1989; 35:381-5.
10. Genco A, Bruni T, Doldi SB, et al. BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients. Obes Surg 2005; 15(8): 1161-4.
11. Dumonceau JM. Evidence-based review of the Bioenterics intragastric balloon for weight loss. Obes Surg 2008; 18(12): 1611-7.
12. Mion F, Ibrahim M, Marjoux S, et al. Swallowable Obalon® gastric balloons as an aid for weight loss: a pilot feasibility study. Obes Surg 2013; 23(5): 730-3.
13. Mathus-Vliegen EMH. Is endoscopy really necessary for placing intragastric balloons? Obes Surg. 2018;28(1):169-75
14. Al-Subaie S, Khalifa S, Buhaimed W, et al. A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single-center, single-surgeon experience. Int J Surg. 2017 Dec;48:16-22. doi: 10.1016/j.ijsu.2017.10.001. Epub 2017 Oct 6.
15. Alsabah S, Al Haddad E, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018 Mar;14(3):311-317. doi: 10.1016/j.soard.2017.12.001. Epub 2017 Dec 9.
16. Jamal MH, Almutairi R, Elabd R, et al. The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal.Obes Surg. 2019 Jan 7. doi: 10.1007/s11695-018-03671-w.
17. Gaur S, Levy S, Mathus-Vliegen L, et al. Balancing risk and reward: a critical review of the intragastric balloon for weight loss. Gastrointest Endosc 2015; 81(6): 1330-6.
18. Imaz I, Martínez-Cervell C, García-Alvarez EE, et al. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7): 841-6.
19. Al-Subaie S, Al-Barjas H, Al-Sabah S, et al. Laparoscopic management of a small bowel obstruction secondary to Elipse intragastric balloon migration: A case report. Int J Surg Case Rep. 2017; 41:287-291. doi: 10.1016/j.ijscr.2017.10.050. Epub 2017 Nov 8.
20. Frimberger E, Kühner W, Weingart J, et al. Percutaneous decompression of an intestinal balloon-case report. Hepatogastroenterology. 1982; 29:38-39.
21. Holland S, Bach D, Duff J. Balloon therapy for obesity-when the balloon bursts. J. Can. Assoc. Radiol. 1985; 36:347-349.
22. Halm U, Grothoff M, Lamberts R. Gastric balloon causing small bowel obstruction: treatment by double-balloon enteroscopy. Endoscopy. 2013;45 Suppl 2 UCTN:E78-9. doi: 10.1055/s-0032-1326265. Epub 2013 Mar 22.
23. Vlachou E, Direkz S, Murino A, et al. Small bowel obstruction caused by a migrated Obalon gastric bariatric balloon: nonsurgical management by antegrade double-balloon panenteroscopy. Endoscopy. 2016 0;48(S 01):E403-E404. doi: 10.1055/s-0042-120289. Epub 2017 Jan 10.
24. Di Saverio S, Bianchini Massoni C, Boschi S, et al. Complete small-bowel obstruction from a migrated intra-gastric balloon: emergency laparoscopy for retrieval via enterotomy and intra-corporeal repair. Obes Surg. 2014 Oct;24(10):1830-2. doi: 10.1007/s11695-014-1271-5.
25. Mousavi Naeini SM, Sheikh M. Bowel Obstruction due to Migration of an Intragastric Balloon Necessitating Surgical Removal before Completion of the Recommended 6 Months. Case Rep Med. 2012; 2012:414095. doi: 10.1155/2012/414095. Epub 2012 Oct 3.
26. Espinet Coll E, Nebreda Durán J, López-Nava Breviere G. A new swallowable intragastric balloon (Elipse®). Coffee for everybody? The position of GETTEMO. Rev Esp Enferm Dig. 2018 Jan;110(1):65. doi: 10.17235/reed.2017.5214/2017.
27. Espinet Coll E, Nebreda Durán J, López-Nava Breviere G, et al. Multicenter study on the safety of bariatric endoscopy. Rev Esp Enferm Dig. 2017 May;109(5):350-357. doi: 10.17235/reed.2017.4499/2016.
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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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