Gastric Artery Embolization Trial for Lessening Appetite Nonsurgically

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).

Inclusion Criteria:

Morbid obesity with a BMI ≥ 40 Age ≥ 22years Ability to lay supine on an angiographic
table <400lbs due to table weight limits Appropriate anesthesia risk as determined by
certified anesthesia provider evaluation preprocedure.

Willing, able and mentally competent to provide written informed consent (to ensure that
all study subjects demonstrate an understanding of the risks of the procedure and also
participate in the informed consent).

Subjects who have failed previous attempts at weight loss through diet, exercise, and
behavior modification (as it is recommended that conservative options, such as supervised
low calorie diets combined with behavior therapy and exercise, should be attempted prior
to enrolling in this study).

Exclusion Criteria:

Less than 22 years of age Major surgery within the past eight weeks Previous gastric,
pancreatic, hepatic and splenic surgery Previous radiation therapy to the left or right
upper quadrant Previous gastric, hepatic, or splenic embolization Any history of portal
venous hypertension Serum creatinine > 1.8 mg/dL History of kidney problems Pregnant or
intend to become pregnant within one year History of severe bleeding disorder (platelet
count less than 40,000) Allergy to materials in the embolic agents (acrylamido polyvinyl
alcohol macromer) Enrolled in another study Any patient who has a history of allergic
reaction to iodinated contrast Abnormal baseline gastric emptying study Patients taking
anti-coagulants or antiplatelet drugs Patients currently taking or requiring chronic use
of NSAID or steroid medications Patients with any chronic upper gastrointestinal
complaints such as pain, nausea or vomiting Patients with any history of peptic ulcer
disease Patients with any indication of gastrointestinal bleeding as documented by
positive stool guaiac and complete blood count with abnormalities.

Patients with any contraindications for monitored anesthesia care or general surgery
Patients with secondary causes of obesity such as Cushing's disease and hypothyroidism
Patients with active substance abuse or alcoholism Patients with defined noncompliance
with previous medical care Patients with certain psychiatric disorders such as
schizophrenia, borderline personality disorder, and uncontrolled depression, and
mental/cognitive impairment that limits the individual's ability to understand the
proposed therapy.

Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded
due to safety concerns.

Patients with hiatal hernia Patients with known aortic disease, such as dissection or
aneurysm Patients with comorbidity such as cancer, peripheral arterial disease or other
cardiovascular disease Patients with any abnormality on their baseline EGD Patients with a
CT Angiogram demonstrate an anatomical variant in left gastric artery anatomy