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Randomized Controlled Trial
. 2013 Dec;145(6):1245-52.e1-5.
doi: 10.1053/j.gastro.2013.08.056. Epub 2013 Sep 6.

Aspiration therapy leads to weight loss in obese subjects: a pilot study

Shelby Sullivan  1 , Richard Stein, Sreenivasa Jonnalagadda, Daniel Mullady, Steven Edmundowicz
Affiliations
Randomized Controlled Trial

Aspiration therapy leads to weight loss in obese subjects: a pilot study

Shelby Sullivan et al. Gastroenterology. 2013 Dec.

Abstract

Background & aims: Obese patients rarely achieve long-term weight loss with only lifestyle interventions. We evaluated the use of endoscopic aspiration therapy for obesity. Aspiration therapy involves endoscopic placement of a gastrostomy tube (A-Tube) and the AspireAssist siphon assembly (Aspire Bariatrics, King of Prussia, PA) to aspirate gastric contents 20 minutes after meal consumption.

Methods: We performed a pilot study of 18 obese subjects who were randomly assigned (2:1) to groups that underwent aspiration therapy for 1 year plus lifestyle therapy (n = 11; mean body mass index, 42.6 ± 1.4 kg/m(2)) or lifestyle therapy only (n = 7; mean body mass index, 43.4 ± 2.0 kg/m(2)). Lifestyle intervention comprised a 15-session diet and behavioral education program.

Results: Ten of the 11 subjects who underwent aspiration therapy and 4 of the 7 subjects who underwent lifestyle therapy completed the first year of the study. After 1 year, subjects in the aspiration therapy group lost 18.6% ± 2.3% of their body weight (49.0% ± 7.7% of excess weight loss [EWL]) and those in the lifestyle therapy group lost 5.9% ± 5.0% (14.9% ± 12.2% of EWL) (P < .04). Seven of the 10 subjects in the aspiration therapy group completed an additional year of therapy and maintained a 20.1% ± 3.5% body weight loss (54.6% ± 12.0% of EWL). There were no adverse effects of aspiration therapy on eating behavior and no evidence of compensation for aspirated calories with increased food intake. No episodes of binge eating in the aspiration therapy group or serious adverse were reported.

Conclusions: In a pilot study, aspiration therapy appears to be a safe and effective long-term weight loss therapy for obesity.

Trial registration: ClinicalTrials.gov NCT00773903.

Keywords: ALT; AT; BDI-II; BMI; Beck Depression Inventory; EDE; EWL; Eating Disorder Examination; Endoscopic Bariatric Therapy; LT; Obesity; Overweight; PEG; Percutaneous Endoscopic Gastrostomy; RCT; alanine aminotransferase; aspiration therapy plus lifestyle therapy; body mass index; excess weight loss; lifestyle therapy only; percutaneous endoscopic gastrostomy; randomized controlled trial.

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Conflict of interest statement

Conflicts of interest: The authors disclose the following: Dr Sullivan has performed contracted research for Aspire Bariatrics, ReShape Medical, and GI Dynamics. Dr Stein has performed contracted research for Aspire Bariatrics, EnteroMedics Inc, and Orexigen Therapeutics, Inc, and has served as a consultant for Aspire Bariatrics on a pivotal trial. Dr Jonnalagadda has performed contracted research for Aspire Bariatrics. Dr Mullady has performed contracted research for Aspire Bariatrics. Dr Edmundowicz has performed contracted research for Aspire Bariatrics, ReShape Medical, and GI Dynamics and has served as a consultant for GI Dynamics.

Figures

Figure 1
Figure 1
Components of AT. (A) Internal components and Skin-Port and (B) external components.
Figure 2
Figure 2
Subject performing aspiration.
Figure 3
Figure 3
(A) Percentage of absolute weight loss and (B) percentage of EWL in subjects in the LT group (n = 4, black triangles), in subjects in the AT group who completed 52 weeks of therapy (n = 10, black diamonds), and in subjects in the AT group who completed 104 weeks of therapy (n = 7, black squares). *Value significantly different from the corresponding value in the LT group, P < .05. Data are expressed as means ± SEM.
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Comment in

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