Gastric Arterial Embolization for Weight Loss

Study Overview
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Brief Summary
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Title: Embolization of Gastric Arterial Supply for Weight Loss Sample size: 10 patients Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery. Study Design: Single center, randomized, prospective, non-blinded pilot study. Study Duration: 12 months (November 2015 - December 2015). Agent: 150-250 micron polyvinyl alcohol particles Primary objective: To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients. Primary objective measure: The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.

Official Title
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Gastric Arterial Embolization for Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Embolization of Left Gastric Artery
* Procedure: Embolization of Gastroepiploic Artery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease Exclusion Criteria: Basic Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment Gastrointestinal Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L Cardiovascular Known aortic pathology such as aneurysm or dissection Peripheral arterial disease Renal Renal insufficiency as evidenced by estimated GFR < 60ml/min.1.73m2 Hematologic/Immunologic/Oncologic/Infectious Acute or chronic infection Active cancer or prior history of cancer <10 years ago Autoimmune disease requiring immunosuppression Neutrophils < 1.5 x 10^9/L Platelets < 50 x 10^9/L INR >1.7 Psychiatric Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization of Left Gastric Artery<br>These patients will have their left gastric artery embolized | Procedure: Embolization of Left Gastric Artery<br>* Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles<br>|
| Experimental: Embolization of Gastroepiploic Artery<br>These patients will have their gastroepiploic artery embolized | Procedure: Embolization of Gastroepiploic Artery<br>* Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | weight change | 1 year | 
| Cardiovascular risk factors | serum lipids, hemoglobin A1C, blood pressure, sleep apnea | 1 year |