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Personalization of Endoscopic Bariatric and Metabolic Therapies Based on Physiology: a Prospective Feasibility Study with a Single Fluid-Filled Intragastric Balloon

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Abstract

Background

The intragastric balloon (IGB) is commonly used for weight loss. Identifying patients who are most likely to tolerate and benefit from IGB therapy will optimize outcomes. Our aims were to prospectively utilize a gastric emptying study to predict intolerance and treatment response with a single fluid-filled IGB and to develop a physiologic prediction model with a treatment algorithm.

Materials and Methods

A total of 32 patients had a gastric emptying study before and 2–3 months after placement of an IGB. Multiple logistic regression analyses were performed to calculate likelihood ratios and to develop a physiologic prediction model.

Results

Patients in the higher gastric retention quartile at baseline had a 6.2-time higher likelihood ratio for early balloon removal secondary to intolerance (p = 0.013). Utilizing baseline gastric emptying to predict intolerance to the IGB may have prevented 75% of early removal cases. Decreased gastric emptying at 3 months after balloon placement was significantly correlated with percent total body weight loss (%TWBL) at 6 and 12 months (p = 0.01 and p = 0.014, respectively). At 6 months after IGB, patients with no change in their gastric emptying at 3 months lost significantly less weight compared with those with increased gastric retention (median %TBWL = 9.0% [4.5–14.7] versus 17.3% [12.2–24.4], p = 0.016).

Conclusion

Utilizing gastric emptying as a physiologic predictor of intolerance and response to the single fluid-filled IGB can improve outcomes. This pilot feasibility trial ushers in the era of personalized endoscopic bariatric therapies to maximize patients’ tolerance, cost-effectiveness, and meaningful weight loss.

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Funding

Testing for gastric emptying study was supported by Cairn Diagnostics (Brentwood, TN) and Apollo Endosurgery (Austin, TX).

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Sanchinarro University Hospital of Madrid, Madrid, Spain

    Gontrand Lopez-Nava & Inmaculada Bautista-Castaño

  2. Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA

    Veeravich Jaruvongvanich, Andrew C. Storm, Daniel B. Maselli, Eric J. Vargas, Reem Matar, Andres Acosta & Barham K. Abu Dayyeh

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  1. Gontrand Lopez-Nava
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  2. Veeravich Jaruvongvanich
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  9. Barham K. Abu Dayyeh
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Contributions

GL, IBS, and BA conceived and designed the study; reviewed the literature; collected, analyzed, and interpreted the data; and drafted the manuscript. EV, FB, AR, AA, and MC conceived and designed the study, and critically revised the manuscript. VJ, ACS, DM, BA, and RM reviewed the literature; collected, analyzed, and interpreted the data; and drafted the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Barham K. Abu Dayyeh.

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Conflict of Interest

Dr. Abu Dayyeh is a consultant for USGI, DyaMX, Hemostasis, BFKW,  Metamodix, Endo-TAGSS, and Boston Scientific. He recieved research support from Apollo Endosurgery, USGI, Boston Scientific, Cairn diagnostic, and Medtronic. He is speaker for Olympus, Johnson and Johnson, and Endogastric Solutions. Dr. Storm is a consultant of Apollo Endosurgery, GI Dynamics, and Endo-TAGSS, and the recipient of research support from Boston Scientific. All other authors report no relevant disclosures.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Additional informed consent was obtained from all individual participants for whom identifying information is included in this article.

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Gontrand Lopez-Nava and Veeravich Jaruvongvanich share co-first authorship.

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Lopez-Nava, G., Jaruvongvanich, V., Storm, A.C. 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 30, 3347–3353 (2020). https://doi.org/10.1007/s11695-020-04581-6

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