The Clinical and Metabolic Effects of Intragastric Balloon on Morbid Obesity and Its Related Comorbidities

다국어 초록 (Multilingual Abstract)

Obesity is becoming increasingly prevalent worldwide, and its metabolic sequelae lead to a significant burden on healthcareresources. Options for the management of obesity include lifestyle modification, pharmacological treatment, surgery, and endoscopicbariatric therapies (EBTs). Among these, EBTs are more effective than diet and lifestyle modification and are less invasive thanbariatric surgery. In recent years, there have been significant advances in technologies pertaining to EBTs. Of all the available EBTs,there is a significant amount of clinical experience and published data regarding intragastric balloons (IGBs) because of theircomparatively long development period. Currently, the United States Food and Drug Administration (FDA) has approved threeIGBs, including Orbera (Apollo Endosurgery, Austin, TX, USA), ReShape Duo (ReShape Medical, San Clemente, CA, USA), andObalon (Obalon Therapeutics, Carlsbad, CA, USA). The aim of this review is to summarize the available literature on the efficacy ofIGBs in weight loss and their impact on obesity-related metabolic diseases.

참고문헌 (Reference)

1 Herve J, "What becomes of patients one year after the intragastric balloon has been removed?" 15 : 864-870, 2005

2 Buchwald H, "Weight and type 2 diabetes after bariatric surgery : systematic review and meta-analysis" 122 : 248-256, 2009

3 Seong Ji Choi, "Various Intragastric Balloons Under Clinical Investigation" 대한소화기내시경학회 51 (51): 407-415, 2018

4 Doldi SB, "Treatment of morbid obesity with intragastric balloon in association with diet" 12 : 583-587, 2002

5 Popov VB, "The impact of intragastric balloons on obesity-related co-morbidities : a systematic review and meta-analysis" 112 : 429-439, 2017

6 Konopko-Zubrzycka M, "The effect of intragastric balloon on plasma ghrelin, leptin, and adiponectin levels in patients with morbid obesity" 94 : 1644-1649, 2009

7 Ponce J, "The REDUCE pivotal trial : a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity" 11 : 874-881, 2015

8 US Food and Drug Administration, "Summary of safety and effectiveness data (SSED): ReShapeTM Integrated Dual Balloon System" FDA

9 US Food and Drug Administration, "Summary of safety and effectiveness data (SSED): Obalon Balloon System" FDA

10 US Food and Drug Administration, "Summary of safety and effectiveness data (SSED): ORBERATM Intragastric Balloon System" FDA

11 Vanden Eynden F, "Small intestine gastric balloon impaction treated by laparoscopic surgery" 11 : 646-648, 2001

12 Mafort TT, "Six-month intragastric balloon treatment for obesity improves lung function, body composition, and metabolic syndrome" 24 : 232-240, 2014

13 Buzga M, "Short-term outcomes of the new intragastric balloon End-Ball®for treatment of obesity" 11 : 229-235, 2016

14 Imaz I, "Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis" 18 : 841-846, 2008

15 Brill JV, "Reimbursement for endoscopic bariatric therapies" 27 : 343-351, 2017

16 "ReShapeTM integrated dual balloon system instructions for use" EnteroMedics Inc

17 Sullivan S, "Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss" 14 : 1876-1889, 2018

18 Mathus-Vliegen EM, "Outcomes of intragastric balloon placements in a private practice setting" 47 : 302-307, 2015

19 Busetto L, "Obstructive sleep apnea syndrome in morbid obesity : effects of intragastric balloon" 128 : 618-623, 2005

20 Fuster JJ, "Obesity-induced changes in adipose tissue microenvironment and their impact on cardiovascular disease" 118 : 1786-1807, 2016

21 Morino M, "Mortality after bariatric surgery : analysis of 13, 871 morbidly obese patients from a national registry" 246 : 1002-1007, 2007

22 Mathus-Vliegen EM, "Los function and obesity : the impact of untreated obesity, weight loss, and chronic gastric balloon distension" 68 : 161-168, 2003

23 Folini L, "Liver steatosis(LS)evaluated through chemical-shift magnetic resonance imaging liver enzymes in morbid obesity; effect of weight loss obtained with intragastric balloon gastric banding" 51 : 361-368, 2014

24 Kim WY, "Large bowel impaction by the BioEnterics Intragastric Balloon(BIB)necessitating surgical intervention" 82 : 202-204, 2000

25 Kushner RF, "Introduction : the state of obesity in 2017" 102 : 1-11, 2018

26 Singh S, "Intragastric balloon versus endoscopic sleeve gastroplasty for the treatment of obesity : a systematic review and meta-analysis" 30 : 3010-3029, 2020

27 Lee YM, "Intragastric balloon significantly improves nonalcoholic fatty liver disease activity score in obese patients with nonalcoholic steatohepatitis : a pilot study" 76 : 756-760, 2012

28 Frutos MD, "Intragastric balloon reduces liver volume in super-obese patients, facilitating subsequent laparoscopic gastric bypass" 17 : 150-154, 2007

29 Rossi A, "Intragastric balloon insertion increases the frequency of erosive esophagitis in obese patients" 17 : 1346-1349, 2007

30 Farina MG, "Intragastric balloon in association with lifestyle and/or pharmacotherapy in the long-term management of obesity" 22 : 565-571, 2012

31 Dastis NS, "Intragastric balloon for weight loss : results in 100 individuals followed for at least 2. 5 years" 41 : 575-580, 2009

32 Yorke E, "Intragastric balloon for management of severe obesity : a systematic review" 26 : 2248-2254, 2016

33 Storm AC, "Intragastric balloon for management of morbid obesity in a candidate for heart transplantation" 36 : 820-821, 2017

34 Gentileschi P, "Intragastric balloon followed by biliopancreatic diversion in a liver transplant recipient : a case report" 19 : 1460-1463, 2009

35 Nieben OG, "Intragastric balloon as an artificial bezoar for treatment of obesity" 1 : 198-199, 1982

36 Choudhary NS, "Intragastric balloon as a novel modality for weight loss in patients with cirrhosis and morbid obesity awaiting liver transplantation" 35 : 113-116, 2016

37 Al-Sabah S, "Intragastric balloon as a bridge procedure in patients with high body mass index" 12 : 1900-1901, 2016

38 Trang J, "Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients-a systematic review and meta-analysis" 57 : 22-29, 2018

39 Guedes MR, "Impact of intragastric balloon treatment on adipokines, cytokines, and metabolic profile in obese individuals" 29 : 2600-2608, 2019

40 Coffin B, "Impact of intragastric balloon before laparoscopic gastric bypass on patients with super obesity : a randomized multicenter study" 27 : 902-909, 2017

41 Mathus-Vliegen EM, "Gastro-oesophageal reflux in obese subjects : influence of overweight, weight loss and chronic gastric balloon distension" 37 : 1246-1252, 2002

42 Geliebter A, "Gastric distention by balloon and testmeal intake in obese and lean subjects" 48 : 592-594, 1988

43 Bazerbachi F, "Fluid-filled versus gas-filled intragastric balloons as obesity interventions : a network meta-analysis of randomized trials" 28 : 2617-2625, 2018

44 Dumonceau JM, "Evidence-based review of the Bioenterics intragastric balloon for weight loss" 18 : 1611-1617, 2008

45 Żurawiński W, "Evaluation of the results of treatment of morbid obesity by the endoscopic intragastric balloon implantation method" 12 : 37-48, 2017

46 Sullivan S, "Endoscopic bariatric and metabolic therapies : new and emerging technologies" 152 : 1791-1801, 2017

47 Machytka E, "ElipseTM, a procedureless gastric balloon for weight loss : a proof-of-concept pilot study" 26 : 512-516, 2016

48 Trande P, "Efficacy, tolerance and safety of new intragastric air-filled balloon(Heliosphere BAG)for obesity : the experience of 17 cases" 20 : 1227-1230, 2010

49 Kotinda A, "Efficacy of intragastric balloons for weight loss in overweight and obese adults : a systematic review and meta-analysis of randomized controlled trials" 30 : 2743-2753, 2020

50 Saber AA, "Efficacy of first-time intragastric balloon in weight loss : a systematic review and meta-analysis of randomized controlled trials" 27 : 277-287, 2017

51 Bužga M, "Effects of the intragastric balloon MedSil on weight loss, fat tissue, lipid metabolism, and hormones involved in energy balance" 24 : 909-915, 2014

52 Tai CM, "Effectiveness of intragastric balloon treatment for obese patients : one-year follow-up after balloon removal" 23 : 2068-2074, 2013

53 Moura D, "Effectiveness of intragastric balloon for obesity : a systematic review and meta-analysis based on randomized control trials" 12 : 420-429, 2016

54 Popov VB, "Effect of intragastric balloons on liver enzymes : a systematic review and meta-analysis" 61 : 2477-2487, 2016

55 Lopez-Nava G, "Dual intragastric balloon : single ambulatory center Spanish experience with 60 patients in endoscopic weight loss management" 25 : 2263-2267, 2015

56 Benjamin SB, "Double-blind controlled trial of the Garren-Edwards gastric bubble : an adjunctive treatment for exogenous obesity" 95 : 581-588, 1988

57 Segula D, "Complications of obesity in adults : a short review of the literature" 26 : 20-24, 2014

58 Peker Y, "Comparison of results of laparoscopic gastric banding and consecutive intragastric balloon application at 18 months : a clinical prospective study" 21 : 471-475, 2011

59 Martyniak K, "Changes in adipose tissue cellular composition during obesity and aging as a cause of metabolic dysregulation" 94 : 59-63, 2017

60 Global BMI Mortality Collaboration, "Body-mass index and all-cause mortality : individual-participant-data meta-analysis of 239 prospective studies in four continents" 388 : 776-786, 2016

61 Genco A, "BioEnterics intragastric balloon : the Italian experience with 2, 515 patients" 15 : 1161-1164, 2005

62 Genco A, "BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients" 30 : 129-133, 2006

63 Ricci G, "Bariatric therapy with intragastric balloon improves liver dysfunction and insulin resistance in obese patients" 18 : 1438-1442, 2008

64 Schauer PR, "Bariatric surgery versus intensive medical therapy in obese patients with diabetes" 366 : 1567-1576, 2012

65 Aune D, "BMI and all cause mortality: systematic review and non-linear dose-response meta-analysis of 230 cohort studies with 3.74 million deaths among 30.3 million participants" 353 : i2156-, 2016

66 Fuller NR, "An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study" 21 : 1561-1570, 2013

67 Stefater MA, "All bariatric surgeries are not created equal : insights from mechanistic comparisons" 33 : 595-622, 2012

68 Machytka E, "Adjustable intragastric balloons : a 12-month pilot trial in endoscopic weight loss management" 21 : 1499-1507, 2011

69 Blüher M, "Adipose tissue inflammation: a cause or consequence of obesity-related insulin resistance?" 130 : 1603-1614, 2016

70 Katsiki N, "Adiponectin, lipids and atherosclerosis" 28 : 347-354, 2017

71 ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee, "ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies" 82 : 425-438, 2015

72 Lopasso FP, "A pilot study to evaluate the safety, tolerance, and efficacy of a novel stationary antral balloon(SAB)for obesity" 42 : 48-53, 2008