Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically
Condition: Arterial Embolization; Other Surgical Procedures; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this pilot study is to achieve the collection of safety and efficacy data in
      patients undergoing left gastric artery embolization for morbid obesity in the United States.
      As secondary goal, the pilot study seeks to obtain quality of life data. This pilot study is
      not designed to achieve new indications for this device.
    

Detailed description: 
      Beadblock will be used intraarterially to occlude in this case the left gastric artery and
      its branches. The left gastric artery supplies the fundus of the stomach, where it is known
      that the hormone ghrelin (one of the hormones responsible for appetite) is produced. Ghrelin
      is a 28 amino acid hunger stimulating peptide and hormone that is produced mainly by P/D1
      cells lining the fundus of the stomach and epsilon cells of the pancreas. Ghrelin has emerged
      as the first identified circulating hunger hormone. Ghrelin is also the only known
      circulating orexigen, or appetite enhancing hormone.

      Left gastric artery embolization may be a minimally invasive alternative to the current
      surgical treatment of gastric bypass or reduction surgery. These treatments have known
      serious complications including anastomotic leaks, bowel obstruction, paralytic ileus, deep
      vein thrombosis, pulmonary embolism, gastrointestinal bleeding, dumping syndrome, and
      anesthesia risks resulting in morbidity and mortality.

      Literature review for gastric artery embolization

      Transarterial embolization is a common interventional procedure used to treat a variety of
      medical conditions. In the image-guided procedure, an embolic, or obstructive, agent is
      inserted through a catheter and placed inside an artery to prevent blood flow in an artery or
      to a specific area of the body. Types of embolic agents include beads, coils, gel foam,as
      well as other materials and devices.

      Gastric artery embolization has been used since the 1970's to treat life threatening gastric
      hemorrhage. This is commonly accepted as standard of care and has been life saving for
      thousands of patients. It is even deemed to be effective enough to be used empirically in the
      setting of angiographically negative life threatening hemorrhage (as a reflection of its
      safety margin).

      Recent animal studies over the past several years in porcine and canine models have shown
      that gastric artery embolization results in the suppression of ghrelin levels and weight
      loss.

      Arepally, et al. (2008) first described the technique of gastric artery embolization to
      reduce weight gain. In a controlled study, he used sodium morrhuate within a porcine model
      with resultant lower ghrelin levels and significantly blunted weight gain (in otherwise
      rapidly growing young swine).

      Paxton, et al. (SIR abstract in 2012, later published in 2013 and 2014) described the
      technique of 40 micron microsphere particle embolization in a similar porcine model that also
      resulted in lowered ghrelin levels and reduced weight gain. Also noted there was no duodenal
      upregulation for ghrelin.

      Bawudun et al. (2012) described a technique of left gastric embolization using mixture of
      bleomycin and lipiodol versus polyvinyl alcohol 500-700 micron particles to create weight
      loss in a canine model without gastric ulceration. In addition, he demonstrated significant
      reduction in subcutaneous fat and plasma ghrelin.

      Kipshidze, et al. (2013) performed the first in man study reported at the annual meeting of
      the American College of Cardiology that showed an average of 45lbs of weight loss in 6 months
      and reduced ghrelin levels in 5 patients with no complications (with endoscopic follow-up) in
      this small series using BeadBlock 300-500 micron particles. According to personal
      correspondence with the author of this study the weight loss is sustained for at least 1 year
      with no complications in these 5 patients. He also noted that an additional 7 patients have
      been treated without complications.

      A recent retrospective case control study presented at the 2013 Radiological Society of North
      American annual meeting found that there was an average of 7.9% decrease in body weight (at 3
      months) in 15 patients who underwent left gastric artery embolization for life threatening
      hemorrhage compared to 1.2% (P=0.001) for age matched controls (who underwent embolization
      other than the left gastric artery for upper gastrointestinal bleeding).
    

Intervention name(s): BeadBlock 300 - 500 Micron; Left Gastric Artery Embolization
Intervention type(s): Device; Procedure
Intervention description(s): Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
Other intervention name(s): GET LEAN
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bariatric Embolization; Gastric Artery Emboliziation; Left Gastric Artery Embolization; Morbid Obesity; Obesity; Weight Loss; Ghrelin; Embolization