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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| left gastric artery embolization | Experimental | Patients undergoing left gastric artery embolization |
|
| healthy diet and exercise | Active Comparator | Patients undergoing healthy diet and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| left gastric artery embolization | Procedure |
| ||
| healthy diet and exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | Unit of Measure: Percentage of excess weight loss [%EWL]. The body weight will be measured within 2-4h after breakfast. | Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months |
| Lipid Profile |
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Inclusion Criteria:
Body mass index (BMI) >30.
No history of gastrointestinal surgery.
Willing, able and mentally competent to provide written informed consent.
Suitable for protocol therapy as determined by the interventional radiology Investigator.
Adequate hematological, hepatic and renal function as follows:
Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR <1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2
Aged between18 and 65 years old.
More than one year's follow-up can be obtained reliably
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhibin Bai | Contact | baizhibin1004@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-jun Teng, Ph.D,MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital,Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29063494 | Derived | Bai ZB, Qin YL, Deng G, Zhao GF, Zhong BY, Teng GJ. Bariatric Embolization of the Left Gastric Arteries for the Treatment of Obesity: 9-Month Data in 5 Patients. Obes Surg. 2018 Apr;28(4):907-915. doi: 10.1007/s11695-017-2979-9. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Behavioral |
|
Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
| 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. | 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. | Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months |
| Abdominal fat content | Abdominal fat content detected by MRI. | 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. | Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months |
| Results of Gastroendoscopic Examination | Photos and clinical reports will be analyzed. | 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. | 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |