The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis

Abstract

Background

Intragastric balloons have been used to bridge the obesity treatment gap with the benefits of being minimally invasive but still required endoscopy. The Elipse intragastric balloon (EIGB) is a swallowable balloon that is spontaneously excreted through a natural orifice at approximately 16 weeks. Several concerns exist, including the treatment efficacy and risk of bowel obstruction. Our meta-analysis aimed to evaluate the efficacy and safety of EIGB.

Methods

A literature search was performed from several databases from database inception to November 2019. Eligible studies must report percent total weight loss (%TWL) after completion of treatment and adverse events. The pooled means and proportions of our data were analyzed using random effects model, generic inverse variance method.

Results

Six studies involving 2013 unique patients met our eligibility criteria and were included. The mean baseline BMI ranged from 30.6 to 36.2. The pooled early removal rate was 2.3% (95% CI, 1.1–3.5%; I2 31%). The pooled %TWL after completion of treatment (4–6 months) was 12.8% (95% CI, 11.6–13.9%; I2 83%) and at 12 months was 10.9% (95% CI, 5.0–16.9%, I2 98%). For serious adverse events, three patients had small bowel obstruction, and one patient had gastric perforation requiring surgery. Early expulsion by emesis and early deflation were seen in 3 and 9 patients, respectively.

Conclusions

This meta-analysis demonstrates that EIGB is a safe device offering an effective weight loss that warrants further studies for its long-term weight loss outcomes. Severe adverse events are rare, and the rate of early removal is low.

This is a preview of subscription content, log in to check access.

Fig. 1
Fig. 2

References

  1. 1.

    National Institutes of Health. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults--The evidence report. Obes Res. 1998;6(Suppl 2):51S–209S.

    Google Scholar 

  2. 2.

    Guh DP, Zhang W, Bansback N, et al. The incidence of co-morbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9:88.

    Article  Google Scholar 

  3. 3.

    Hales CM, Carroll MD, Fryar CD, et al. Prevalence of Obesity Among Adults and Youth: United States, 2015-2016. NCHS Data Brief. 2017;(288):1–8.

  4. 4.

    Mechanick JI, Youdim A, Jones DB, et al. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, the Obesity Society, and American Society for Metabolic & Bariatric Surgery. Surg Obes Relat Dis. 2013;9(2):159–91.

    Article  Google Scholar 

  5. 5.

    Kim SH, Chun HJ, Choi HS, et al. Current status of intragastric balloon for obesity treatment. World J Gastroenterol. 2016;22(24):5495–504.

    CAS  Article  Google Scholar 

  6. 6.

    Bazerbachi F, Vargas EJ, Abu Dayyeh BK. Endoscopic bariatric therapy: a guide to the intragastric balloon. Am J Gastroenterol. 2019;114(9):1421–31.

    Article  Google Scholar 

  7. 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):512–6.

    Article  Google Scholar 

  8. 8.

    Genco A, Ernesti I, Ienca R, et al. Safety and efficacy of a new swallowable intragastric balloon not needing endoscopy: early Italian experience. Obes Surg. 2018;28(2):405–9.

    CAS  Article  Google Scholar 

  9. 9.

    Choi SJ, Choi HS. Various intragastric balloons under clinical investigation. Clin Endosc. 2018;51(5):407–15.

    Article  Google Scholar 

  10. 10.

    Angrisani L, Santonicola A, Vitiello A, et al. Elipse balloon: the pitfalls of excessive simplicity. Obes Surg. 2018;28(5):1419–21.

    Article  Google Scholar 

  11. 11.

    DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177–88.

    CAS  Article  Google Scholar 

  12. 12.

    Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ. 2003;327(7414):557–60.

    Article  Google Scholar 

  13. 13.

    Sterne JA, Egger M. Funnel plots for detecting bias in meta-analysis: guidelines on choice of axis. J Clin Epidemiol. 2001;54(10):1046–55.

    CAS  Article  Google Scholar 

  14. 14.

    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):512–6.

  15. 15.

    Alsabah S, Al Haddad E, Ekrouf S, et al. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis. 2018;14(3):311–7.

  16. 16.

    Espinet Coll E, Carrasco Clavijos S, Diaz Galan P, et al. Feasibility, results and endoscopic requirements of the Elipse(R) swallowable intragastric balloon: initial experience. Rev Esp Enferm Dig. 2019;111

  17. 17.

    Roberta Ienca AD, GiardielloC, Rosa M, Jarallah M, Kolmer S, Hugues SEBBAG, Hansoulle J, Quartararo G, Zouaghi A, Juneja GK, Arau RT, Pomar AP, Badiuddin F, Dargent J, Durou J, Urbain P, Paveliu S, di Cola RS, Selvaggio C, Alkuwari M. Procedureless Gastric Balloon for Weight Loss: Multi-Center Experience in 1623 Consecutive Patients. 2019. p. S33.

  18. 18.

    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;29(4):1236–41.

  19. 19.

    Yannis Raftopoulos ED, Karen R, Kristen C, et al. An intensive 52-week nutritional, Exercise and Behavior Modification Program: Comparison With or Without the Elipse Intragastric Balloon. Surg Obes Rel Dis. 2019;

  20. 20.

    Kozlowski T, Kozakiewicz K, Dadan J, et al. Innovative solutions in bariatric surgery. Gland Surg. 2016;5(5):529–36.

    Article  Google Scholar 

  21. 21.

    Glass J, Chaudhry A, Zeeshan MS, et al. New era: endoscopic treatment options in obesity-a paradigm shift. World J Gastroenterol. 2019;25(32):4567–79.

    Article  Google Scholar 

  22. 22.

    Zheng Y, Wang M, He S, et al. Short-term effects of intragastric balloon in association with conservative therapy on weight loss: a meta-analysis. J Transl Med. 2015;13:246.

    Article  Google Scholar 

  23. 23.

    Bazerbachi F, Vargas Valls EJ, Abu Dayyeh BK. Recent clinical results of endoscopic bariatric therapies as an obesity intervention. Clin Endosc. 2017;50(1):42–50.

    Article  Google Scholar 

  24. 24.

    Ribeiro da Silva J, Proenca L, Rodrigues A, et al. Intragastric balloon for obesity treatment: safety, tolerance, and efficacy. GE Port J Gastroenterol. 2018;25(5):236–42.

    Article  Google Scholar 

  25. 25.

    Meshkinpour H, Hsu D, Farivar S. Effect of gastric bubble as a weight reduction device: a controlled, crossover study. Gastroenterology. 1988;95(3):589–92.

  26. 26.

    Force ABET, Committee AT, Abu Dayyeh BK, et al. ASGE bariatric endoscopy task force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointest Endosc. 2015;82(3):425–38. e5

  27. 27.

    Sullivan S, Swain J, Woodman G, 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):1876–89.

  28. 28.

    Ponce J, Woodman G, Swain J, 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):874–81.

  29. 29.

    Stavrou G, Tsaousi G, Kotzampassi K. Life-threatening visceral complications after intragastric balloon insertion: is the device, the patient or the doctor to blame? Endosc Int Open. 2019;7(2):E122–E9.

  30. 30.

    Voelker R. Deaths reported after intragastric balloon surgery. JAMA. 2017;318(11):996.

  31. 31.

    Finkelstein EA, Verghese NR. Incremental cost-effectiveness of evidence-based non-surgical weight loss strategies. Clin Obes. 2019;9(2):e12294.

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Veeravich Jaruvongvanich.

Ethics declarations

Conflict of Interests

The authors declare that they have no conflict of interest.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.

Informed Consent

Informed consent does not apply.

Disclosure Statement

The authors have nothing to disclose.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic Supplementary Material

Supplementary Item 1

Study quality assessment based on NIH criteria (DOCX 70 kb)

Supplementary Item 2

Search strategy (DOCX 18 kb)

Supplementary Item 3

3 Flow diagram for study selection (JPEG 56 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Vantanasiri, K., Matar, R., Beran, A. et al. The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis. OBES SURG 30, 3341–3346 (2020). https://doi.org/10.1007/s11695-020-04522-3

Download citation

Keywords

  • Gastric balloon
  • Procedureless Gastric Balloon
  • Elipse Intragastric Balloon