The purpose of this study is to evaluate the safety and effectiveness of left gastric artery embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight loss. Although there are many ways to treat morbid obesity, surgery is currently the only effective method to be confirmed. But surgical treatment is likely to carry a high risk of treatment-related complications, such as fistula or intestinal obstruction, etc. This study is designed to help treat obesity using a method of transvascular interventional therapy, which is minimally invasive and non-surgical.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China
RECRUITINGWeight Loss
Unit of Measure: Percentage of excess weight loss \[%EWL\]. The body weight will be measured within 2-4h after breakfast.
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Blood pressure
The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Lipid Profile
Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Number of Patients with Adverse Events
Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.
Time frame: post-op 30 days
Ghrelin levels
Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Abdominal fat content
Abdominal fat content detected by MRI.
Time frame: Baseline, post-op 1 month,6 months,12 months
Leptin levels
Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.
Time frame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Results of Gastroendoscopic Examination
Photos and clinical reports will be analyzed.
Time frame: Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
Quality of Life Parameters Survey
N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.
Time frame: 12 months
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