Gastric Arterial Embolization for Weight Loss

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Procedure: Embolization of Left Gastric Artery; Procedure: Embolization of Gastroepiploic Artery

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 15-9576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO