Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation

Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated
that, by the year 2030, 38% of the world's adult population will be overweight and another
20% obese .An expert panel convened by the NIH stated that for the first time in history, the
steadily improving worldwide life expectancy could level off or even decline, as the result
of increasing obesity.

Liver cirrhosis with portal hypertension and HCC:

The problem: Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor
seen in the setting of cirrhosis, which itself can be of varying etiology. NASH as cause for
liver cirrhosis and HCC has been growing in last decade. Although Hepatitis C is currently
the most common indication for liver transplant, longitudinal trends show that NASH has a
trajectory to become the most common.

Current options in management: Patients who develop HCC in the context of underlying chronic
liver disease complicated by portal hypertension are not candidates for resection therapy;
rather, orthotopic liver transplantation (OLT) offers the best option for cure and long-term
survival. Most transplant centers have strict criteria for OLT; one of the most common is a
BMI < 35 kg/m2. Most NASH patients with HCC will have a high BMI. Unfortunately in presence
of HCC these patients have a very limited time to lose enough weight to qualify to be listed.
Lifestyle modification and medical therapies are relatively ineffective. Bariatric surgery is
contraindicated in patients with portal hypertension due to significant increase in
post-operative mortality, more relevant in patient listed to liver transplantation.

Thus a safe and effective minimally invasive option is needed. Based on currently available
data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of
about 10.5% in 3-6 months, with a high safety profile. In patients who have cirrhosis and
portal hypertension with HCC and who are not transplant candidates due to morbid obesity ,
appropriate and timely weight loss of 10.5% in 3-6 months by performing LGAE may allow them
to be listed and transplanted before their cirrhosis and tumor reaches an inoperable stage(
within Milan criteria). In patients with HCC, the procedure can be performed concurrently
with the procedure of Trans arterial chemoembolization which is commonly used in down staging
HCC to Milan criteria.

Inclusion Criteria:

- Male or Female, aged 18 years or older.

- Willing, able and mentally competent to provide written informed consent and willing
to comply with all study procedures and be available for the duration of the study

- BMI >35 kg/m2

- Adequate hematological, hepatic and renal function as follows:

- Hematological: Platelets > 50 x 109/L, INR <1.5

- Hepatic : Total bilirubin <3 mg/dL

- Renal: Estimated GFR > 60ml/min.1.73m2

- Clinical, laboratory and radiographic evidence (ultrasound/ CT/MRI) of cirrhosis of
any etiology with portal hypertension and concomitant HCC (treated or untreated).

- Besides a BMI >35 kg/m2, otherwise eligible for liver transplantation

- Suitable for protocol therapy as determined by the interventional radiology
Investigator.

Exclusion Criteria:

- Pregnancy

- Active substance abuse

- Significant psychiatric problems, severe enough to cause suffering or a poor ability
to function in life. Center for Epidemiological Studies Depression (CESD) score < 16.

- Significant alcohol consumption ( >20 g/day in women, >30 g/day in men)

- Weight > 400 lbs.

- Presence of systemic illness or other medical conditions relevant to survival .(Note
that the presence of HCC will not be considered an exclusion criteria)

- Metastatic cancer

- Evidence of decompensated liver disease (uncontrolled ascites, or uncontrolled
spontaneous encephalopathy)

- prior surgical weight loss procedures including gastroplasty, jejunoileal, or
jejunocolic bypass, total parenteral nutrition within the past 6 months; Prior history
of gastric pancreatic, hepatic, and/or splenic surgery

- Prior embolization to the stomach, spleen or liver.

- If review of available prior imaging studies (i.e. CT, MRI, or US) shows potential
anatomical variations, presence of severe atheromatous disease, large arteriovenous
shunting of blood.

- Abnormal Endoscopy - large sliding hiatal hernia or paraesophageal hernia, active
peptic ulcer disease, active H. pylori infection

- History of abnormal Nuclear Gastric Motility examination-defined as delayed emptying
of gastric contents > 90%, 60% and 10% at 1 hour, 2 hours, and 4 hours respectively.

- ASA Class 4 or 5

- Child Pugh classification C