A Systematic Review on Intragastric Balloons and TransPyloric Shuttle in Obesity Treatment

Abstract

Endoscopic bariatric procedures in the treatment of obesity have become widespread in recent years. In this systematic review, it was aimed to assess the role of intragastric balloons and transpyloric shuttle in the treatment of obesity. A comprehensive search was conducted using the search terms “Intragastric Balloon” and “TransPyloric Shuttle” in PubMed, Cochrane Library and Web of Science databases from 1st of December to 25th of December in 2020. Twenty-seven clinical studies (24 studies on intragastric balloons and 3 studies on transpyloric shuttle) were assessed. It is clear that both methods have significant positive effects on obesity-related comorbidities and weight loss. These techniques also have potential to reduce comedications in patients with type 2 diabetes mellitus and obesity. The most important differences between intragastric balloons and transpyloric shuttle are in the severity and frequency of the complications they cause. While the most common complications related to intragastric balloons are vomiting, nausea, bloating, and abdominal pain, the most common complications due to transpyloric shuttle are gastroduodenal ulcers, gastroesophageal reflux disease, and sore throat. In addition, one of the most important finding is that the type and structure of the balloon, as well as the application period and position of the balloon in the stomach, may cause changes in the adverse and practical effects of intragastric balloons. As a conclusion, intragastric balloon application is a relatively effective short term treatment and relatively safe endoscopic technique used in patients with obesity to improve comorbidities accompanying obesity, but with risks of adverse events. On the other hand, the safety profile of the transpyloric shuttle still needs to be improved.

Keywords

• Gastric balloon
• obesity management
• endoscopic gastrointestinal surgery

Obezite Tedavisinde İntragastrik Balonlar ve TransPyloric Shuttle Üzerine Sistematik Bir İnceleme

Abstract

Endoskopik bariatrik prosedürlerin obezite tedavisinde kullanımı son yıllarda yaygınlaşmaya başlamıştır. Bu sistematik derlemede, obezite tedavisinde intragastrik balon ve transpilorik shuttle uygulamalarının rolünün değerlendirilmesi amaçlanmıştır. 1 Aralık 2020 – 25 Aralık 2020 tarihleri arasında PubMed, Cochrane Library ve Web of Science veri tabanlarında “Intragastric Balloon” ve “TransPyloric Shuttle” arama terimleri kullanılarak kapsamlı bir arama yapılmıştır. Toplam yirmi yedi klinik çalışma (intragastrik balonlarla ilgili 24 ve transpilorik shuttle ile ilgili 3 çalışma) değerlendirilmiştir. Her iki yöntemin de ağırlık kaybı ve obeziteye bağlı komorbiditeler üzerine önemli olumlu etkilerinin olduğu açıktır. Bu tekniklerin ayrıca tip 2 diyabet ve obezitesi olan hastalarda ilaç kullanımını azaltma potansiyeli de bulunmaktadır. İntragastrik balon ve transpilorik shuttle uygulamaları arasındaki en önemli fark, neden oldukları komplikasyonların sıklığı ve şiddetidir. İntragastrik balonlar ile ilişkili en sık görülen komplikasyonlar bulantı, kusma, karın ağrısı ve şişkinlik iken, transpilorik shuttle ile ilişkili en sık görülen komplikasyonlar gastroduodenal ülserler, gastroözofageal reflü hastalığı ve boğaz ağrısıdır. Tüm bunlara ek olarak elde edilen en önemli bulgulardan birisi de balonların tipinin ve yapısının yanı sıra, balonun uygulama süresi ve midedeki pozisyonunun da intragastrik balonların olumsuz ve pratik etkilerinde değişikliklere neden olabileceği sonucudur. Sonuç olarak, intragastrik balon uygulaması, obeziteye eşlik eden komorbiditeleri iyileştirmek için obez hastalarda kullanılan, ancak yan etki riskleri olan ve nispeten kısa süreli etkili bir endoskopik tekniktir. Diğer yandan, transpilorik shuttle tekniğinin güvenlik profilinin iyileştirilmesi gerekmektedir.

Keywords

• Gastrik balon
• obezite yönetimi
• endoskopik gastrointestinal cerrahi

References

1. Papalazarou A, Yannakoulia M, Kavouras SA, Komesidou V, Dimitriadis G, George Dimitriadis, et al. Lifestyle intervention favorably affects weight loss and maintenance following obesity surgery. Obesity. 2010;18(7):1348-1353.
2. Cheng J, Gao J, Shuai X, Wang G, Tao K. The comprehensive summary of surgical versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomized controlled trials. Oncotarget. 2016;7(26):39216-39230.
3. Choi SJ, Choi HS. Various intragastric balloons under clinical investigation. Clin Endosc. 2018;51(5):407-415.
4. Dayyeh BKA. Intragastric balloons for obesity management. Gastroenterol Hepatol. 2017;13(12): 737-739.
5. Samsom M, Hauskens T, Mundt M. Gastric accommodation is influenced by the presence of an intragastric balloon. Gastroenterology. 2000;118(4):A621.
6. Gómez V, Woodman G, Abu Dayyeh BKA. Delayed gastric emptying as a proposed mechanism of action during intragastric balloon therapy: results of a prospective study. Obesity. 2016;24(9):1849-1853.
7. Vargas EJ, Bazerbachi F, Calderon G, Prokop LJ, Gomez V, Murad MH, et al. Changes in time of gastric emptying after surgical and endoscopic bariatrics and weight loss: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2020;18(1):57-68.
8. Papavramidis TS, Stavrou G, Papakostas P, Grosomanidis V, Kokkota S, Michalopoulos A, et al. Displacement of the intragastric balloon from the fundus to the antrum results in enhanced weight loss. Obes Surg. 2018;28(8):2374-2378.

9. Kim SH, Chun HJ, Choi HS, Kim ES, Keum B, Jeen YT. Current status of intragastric balloon for obesity treatment. World J Gastroenterol. 2016;22(24):5495-5504.
10. Sachdev P, Reece L, Thomson M, Natarajan A, Copeland RJ, Wales JK, et al. Intragastric balloon as an adjunct to lifestyle programme in severely obese adolescents: impact on biomedical outcomes and skeletal health. Int J Obes. 2018;42(1):115-118.
11. Mathus-Vliegen EMH, Eichenberger RI. Fasting and meal-suppressed ghrelin levels before and after intragastric balloons and balloon-induced weight loss. Obes Surg. 2014;24(1):85-94.
12. Mion F, Napoléon B, Roman S, Malvoisin E, Trepo F, Pujol B, et al. Effects of intragastric balloon on gastric emptying and plasma ghrelin levels in non-morbid obese patients. Obes Surg. 2005;15(4):510-516.
13. Konopko-Zubrzycka M, Baniukiewicz A, Wroblewski E, Kowalska I, Zarzycki W, Górska M, et al. The effect of intragastric balloon on plasma ghrelin, leptin, and adiponectin levels in patients with morbid obesity. J Clin Endocrinol Metab. 2009;94(5):1644-1649.
14. Fuller NR, Lau NS, Denyer G, Caterson ID. An intragastric balloon produces large weight losses in the absence of a change in ghrelin or peptide YY. Clin Obes. 2013;3(6):172-179.
15. Tate CM, Geliebter A. Intragastric balloon treatment for obesity: FDA safety updates. Adv Ther. 2018;35(1):1-4.
16. Yorke E, Switzer NJ, Reso A, Shi X, De Gara C, Birch D, et al. Intragastric balloon for management of severe obesity: a systematic review. Obes Surg. 2016;26(9):2248-2254.
17. Imaz I, Martínez-Cervell C, García-Álvarez EE, Sendra-Gutiérrez JM, González-Enríquez J. Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obes Surg. 2008;18(7):841-846.
18. Moura D, Oliveira J, De Moura EGH, Bernardo W, Neto MG, Campos J, 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):420-429.
19. Saruç M, Böler D, Karaarslan M, Baysal Ç, Rasa K, Çakmakçı M, et al. Intragastric balloon treatment of obesity must be combined with bariatric surgery: a pilot study in Turkey. Turk J Gastroenterol. 2010;21(4):333-337.
20. Saber AA, Shoar S, Almadani MW, Zundel N, Alkuwari MJ, Bashah MM, et al. Efficacy of first-time intragastric balloon in weight loss: a systematic review and meta-analysis of randomized controlled trials. Obes Surg. 2017;27(2):277-287.
21. Ashrafian H, Monnich M, Braby TS, Smellie J, Bonanomi G, Efthimiou E. Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series. Surg Obes Relat Dis. 2018;14(11):1691-1699. Coffin B, Maunoury V, Pattou F, Hébuterne X, Schneider S, Coupaye M, et al. Impact of intragastric balloon before laparoscopic gastric bypass on patients with super obesity: a randomized multicenter study. Obes Surg. 2017;27(4):902-909.
22. Mitura K, Garnysz K. Tolerance of intragastric balloon and patient’s satisfaction in obesity treatment. Wideochir Inne Tech Maloinwazyjne. 2015;10(3):445-449.
23. Ponce J, Woodman G, Swain J, Wilson E, English W, Ikramuddin S, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. 2015;11(4):874-881.
24. Lopez-Nava G, Bautista-Castaño I, Jimenez-Baños A, Fernandez- Corbelle JP. Dual intragastric balloon: single ambulatory center Spanish experience with 60 patients in endoscopic weight loss management. Obes Surg 2015;25(12):2263-2267.
25. Palmisano S, Silvestri M, Melchioretto B, Giuricin M, Giudici F, Lucchetta A, et al. Intragastric balloon device: weight loss and satisfaction degree. Obes Surg. 2016;26(9):2131-2137.
26. Mariani S, Fiore D, Persichetti A, Basciani S, Lubrano C, Poggiogalle E, et al. Circulating SIRT1 increases after intragastric balloon fat loss in obese patients. Obes Surg. 2016;26(6):1215-1220.
27. Fernandes FAM, Carvalho GL, Lima DL, Rao P, Shadduck PP, Montandon ID, et al. Intragastric balloon for overweight patients. JSLS. 2016;20(1):e2015.00107.
28. Courcoulas A, Dayyeh BKA, Eaton L, Robinson J, Woodman G, Fusco M, et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes. 2017;41(3):427-433.
29. Al-Subaie S, Khalifa S, Buhaimed W, Al-Rashidi S. A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: a single-center, single-surgeon experience. Int J Surg. 2017;48:16-22.
30. Żurawiński W, Sokołowski D, Krupa-Kotara K, Czech E, Sosada K. Evaluation of the results of treatment of morbid obesity by the endoscopic intragastric balloon implantation method. Wideochir Inne Tech Maloinwazyjne. 2017;12(1):37-48.
31. Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, De Mendonça LMC, et al. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017;15(1):1-6.
32. Da Silva JR, Proença L, Rodrigues A, Pinho R, Ponte A, Rodrigues J, et al. Intragastric balloon for obesity treatment: safety, tolerance, and efficacy. GE Port J Gastroenterol. 2018;25(5):236-242.
33. Genco A, Ernesti I, Ienca R, Casella G, Mariani S, Francomano D, et al. Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early Italian experience. Obes Surg. 2018;28(2):405- 409.
34. Reimão SM, Da Silva MER, Nunes GC, Mestieri LHM, Dos Santos RF, De Moura EGH. Improvement of body composition and quality of life following intragastric balloon. Obes Surg 2018;28(6):1806-1808.
35. Foroutan M, Ardeshiri M. Obesity treatment by Bioenterics intragastric balloon: Iranian results. Eur J Transl Myol. 2018;28(3):300-303.
36. Sullivan S, Swain J, Woodman G, Edmundowicz S, Hassanein T, Shayani V, et al. Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surg Obes Relat Dis. 2018;14(12):1876-1889.
37. Alsabah S, Al Haddad E, Ekrouf S, Almulla A, Al-Subaie S, Al Kendari M. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311-317.
38. Guedes MR, Fittipaldi-Fernandez RJ, Diestel CF, Klein MRST. Changes in body adiposity, dietary intake, physical activity and quality of life of obese individuals submitted to intragastric balloon therapy for 6 months. Obes Surg. 2019;29(3):843-850.
39. Jamal MH, Almutairi R, Elabd R, AlSabah SK, Alqattan H, Altaweel T. 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;29(4):1236-1241.
40. Guedes MR, Fittipaldi-Fernandez RJ, Diestel CF, Klein MRST. Impact of Intragastric Balloon Treatment on Adipokines, Cytokines, and Metabolic Profile in Obese Individuals. Obes Surg. 2019;29(8):2600-2608.
41. Madeira E, Madeira M, Guedes EP, Mafort TT, Moreira RO, De Mendonça LMC, et al. Impact of weight loss with intragastric balloon on bone density and microstructure in obese adults. J Clin Densitom. 2019;22(2): 279-286.
42. Fittipaldi-Fernandez RJ, Zotarelli-Filho IJ, Diestel CF, Klein MRST, De Santana MF, De Lima JHF, et al. Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment. Obes Surg. 2021;31:787- 796.
43. Lopez-Nava G, Jaruvongvanich V, Storm AC, Maselli DB, Bautista- Castaño I, Vargas EJ, et al. Personalization of Endoscopic Bariatric and Metabolic Therapies Based on Physiology: a Prospective Feasibility Study with a Single Fluid-Filled Intragastric Balloon. Obes Surg. 2020;30(9):3347-3353.
44. Ibrahim M, Talha A, Hasouna E. Short-term results of intragastric balloon for management of Egyptian obese patients. Egypt J Surg. 2019;38(4):802-806.
45. Chung H. Endoscopic accessories used for more advanced endoluminal therapeutic procedures. Clin Endosc. 2017;50(3):234-241.
46. Marinos G, Eliades C, Muthusamy VR, Iki K, Kline C, Narciso HL, et al. First clinical experience with the transpyloric shuttle device, a non-surgical endoscopic treatment for obesity: results from a 3-month and 6-month study. Proceedings of the SAGES. 2013;17-20.
47. Rothstein RI, Woodman G, Swain JM, De La Cruz N, Kushnir V, Pryor AD, et al. Transpyloric shuttle treatment improves cardiometabolic risk factors and quality of life in patients with obesity: results from a randomized, double-blind, sham-controlled trial. Gastroenterology. 2019;156(6):237-237.
48. Sartoretto A, Marinos G, Sui Z. Clinical feasibility and safety of using the upgraded transpyloric shuttle for weıght loss in obese patients. Gastrointest Endosc. 2019;89(6):AB268-AB269.
49. Marinos G, Eliades C, Muthusamy VR, Greenway F. Weight loss and improved quality of life with a nonsurgical endoscopic treatment for obesity: clinical results from a 3-and 6-month study. Surg Obes Relat Dis. 2014;10(5):929-934.