Endoscopy 2017; 49(02): 108-109
DOI: 10.1055/s-0043-100506
Editorial
© Georg Thieme Verlag KG Stuttgart · New York

A new gastric balloon for weight loss that eliminates the need for endoscopy – good news for the bariatrician

Refering to Machytka E et al. p. 154–160
Steven A. Edmundowicz
Gastroenterology, University of Colorado Denver School of Medicine, Aurora, Colorado, United States
,
Sullivan Shelby
Gastroenterology, University of Colorado Denver School of Medicine, Aurora, Colorado, United States
› Author Affiliations
Further Information

Publication History

Publication Date:
01 February 2017 (online)

The world is in the midst of an obesity epidemic that appears to be growing [1] despite recent advances in pharmacology and new endoscopic obesity treatment options. Gastric balloons have been available worldwide to treat obesity for over two decades. Typically, their use would involve endoscopic placement and removal and concomitant exposure to a moderately intense lifestyle program that involves at least monthly visits to the individuals delivering the lifestyle therapy. Recently an ingested gas-filled balloon has been approved for use in the United States that eliminates the necessity for endoscopic placement [2]. In this issue of Endoscopy, Machtyka et al. [3] describe an open-label trial of an innovative new balloon that is ingested and then filled with fluid once its position is confirmed in the stomach. The patient undergoes lifestyle therapy with the benefit of the gastric balloon for 4 months. Then the balloon spontaneously deflates and is passed through the gastrointestinal (GI) tract; the entire therapy is thus completed without endoscopy.

The concept of an ingestible balloon that can deflate and pass through the GI tract is appealing clinically and economically. The success of this approach revolves around overcoming the technical challenges of designing a decompression system that is safe and reliable. Not only must the device deflate at the appropriate time (defined by the designers as 4 months), the therapy time must provide significant weight loss and health benefits, the deflation must be complete, and the deflated balloon must not obstruct the GI tract. The results of this trial suggest that many of these hurdles have been initially overcome. The Elipse balloon appeared to be successfully swallowable by the study participants. The duration of balloon therapy was 4 months in the majority of participants and the balloon passed through the GI tract of most of them with no issues. Total body weight loss was measured at 10% for the group which is within an acceptable range with the use of a fluid-filled gastric balloon.

Several issues developed during the trial that may be of concern. Among the 34 participants, 4 became acutely nauseated and regurgitated the deflated balloon at the time of balloon rupture. This likely represents pyloric obstruction by the deflated balloon, and in further studies might lead to adverse events (aspiration, Mallory–Weiss tears, etc.) depending on the timing of the balloon failure and the patient’s activities at that time. This inconvenience has to be weighed against the alternative of endoscopic balloon deflation and removal which, as stated by the authors, is not without cost and risk. The more important concern is: What is the risk of balloon impaction in the small bowel and will this require operative intervention in a significant number of patients? While that has not been experienced to date, only a small number of participants has been studied. Must all patients with prior abdominal or pelvic surgeries be excluded from use of this balloon? Should some form of patency test be applied before the balloon is placed? As the patient series expands, will premature balloon decompression become a factor? For those patients who may have difficulty with balloon passage, should the manufacturers also develop an ingestible balloon that is saline-filled but requires endoscopic removal? Clearly, more questions than answers are generated by this pilot study.

Regardless, this must be viewed as an important step forward in the management of obesity. The real innovation of this device is that it removes the endoscopist from the treatment of obesity. It not only broadens the population that may benefit from the therapy by reducing cost but it expands gastric balloon therapy to our nonendoscopist colleagues and provides a new tool to add to the armamentarium of medications, diet programs, and lifestyle modification. With millions of patients worldwide affected by the obesity epidemic and so few of them obtaining any useful therapy, any effective and safe addition to the treatment options is welcome. Hopefully, with further study and a larger patient exposure this innovative approach will prove to be a useful and safe option for our patients. Furthermore, even the busiest endoscopists could find time to place these balloons between longer cases.

 
  • References

  • 1 Flegal KM, Kruszon-Moran D, Carroll MD. et al. Trends in obesity among adults in the United States, 2005 to 2014. JAMA 2016; 315: 2284-2291
  • 2 Sullivan S, Swain JM, Woodman G. et al. The Obalon swallowable 6-month balloon system is more effective than moderate intensity lifestyle therapy alone: results from a 6-month randomized sham controlled trial. Gastroenterology 2016; 150: S1267
  • 3 Machytka E, Gaur S, Chuttani R. et al. Elipse, The first procedureless gastric balloon for weight loss: a prospective, observational, open-label, multicenter study. Endoscopy 2017; 49: 154-160