Clinical trial NCT02786108: Bariatric Arterial Embolization for Morbid Obesity
Official title: Bariatric Arterial Embolization for Morbid Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Morbid Obesity
Keywords: left gastric artery
embolization
obesity
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight Loss
timeFrame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
measure: Lipid Profile
timeFrame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
measure: Number of Patients with Adverse Events
timeFrame: post-op 30 days
measure: Ghrelin levels
timeFrame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
measure: Abdominal fat content
timeFrame: Baseline, post-op 1 month,6 months,12 months
measure: Leptin levels
timeFrame: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
measure: Results of Gastroendoscopic Examination
timeFrame: Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months
measure: Quality of Life Parameters Survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-jun Teng, Ph.D,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.