Bariatric Arterial Embolization for Morbid Obesity

Phase 3

• Conditions: Morbid Obesity
• Interventions: Behavioral: healthy diet and exercise; Procedure: left gastric artery embolization

• Registration Number: NCT02786108
• Lead Sponsor: Zhongda Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-05
• Last Update Posted: 2016-06-07
• Primary Completion: 2017-10
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Body mass index (BMI) >30.

2. No history of gastrointestinal surgery.

3. Willing, able and mentally competent to provide written informed consent.

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

5. 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

6. Aged between18 and 65 years old.

7. More than one year's follow-up can be obtained reliably

Exclusion Criteria

1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery
2. Prior embolization to the stomach, spleen or liver
3. Prior or current history of peptic ulcer disease
4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
5. Portal venous hypertension or cirrhosis
6. Less than 18 years or older than 65 years of age
7. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute an estimated glomerular filtration rate of < 60 milliliters per minute
8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
10. Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.
11. Patients currently taking or requiring chronic use of NSAID or steroid medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy diet and exercise	healthy diet and exercise	Patients undergoing healthy diet and exercise
left gastric artery embolization	left gastric artery embolization	Patients undergoing left gastric artery embolization

Primary Outcome Measures

Name	Time	Method
Weight Loss	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	Unit of Measure: Percentage of excess weight loss \[%EWL\]. The body weight will be measured within 2-4h after breakfast.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.
Lipid Profile	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.
Number of Patients with Adverse Events	post-op 30 days	Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.
Ghrelin levels	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.
Leptin levels	Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months	Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.
Quality of Life Parameters Survey	12 months	N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.
Abdominal fat content	Baseline, post-op 1 month,6 months,12 months	Abdominal fat content detected by MRI.
Results of Gastroendoscopic Examination	Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months	Photos and clinical reports will be analyzed.

Trial Locations

Locations (1)

Zhongda Hospital,Southeast University; 🇨🇳 Nanjing, Jiangsu, China