Bariatric Embolization Trial for the Obese Nonsurgical
试验速览
- 阶段
- 1 期
- 入组人数
- 5
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety profile of bariatric embolizations and confirm published reports of sustained post-procedural weight loss, and pathologically assess post-procedural metabolic effects.
详细描述
Since 2003, the proportion of Canadians who were obese has increased 17.5%. Obesity is ranked as the fifth leading risk for mortality globally. Obesity has been strongly linked to numerous comorbidities, including type II diabetes, hyperlipidemia, hypertension, obstructive sleep apnea, heart disease, stroke, asthma, cancer, and depression.
The pathophysiology of obesity is complex and inadequately understood. Nevertheless, an energy imbalance is fundamentally at fault. As recently as 1996, ghrelin, the hormonal stimulus for hunger was identified. Further research has revealed that ghrelin, predominantly produced in the fundus of the stomach, stimulates appetite and increases serum concentrations of growth hormone, adrenocorticotropic hormone, cortisol, prolactin, and glucose.
Congruously, the complexity of obesity is reflected in the efficacy of modern therapy. Treatment for obesity lies along a spectrum of available modalities beginning with diet modification, exercise therapy, pharmacotherapy, and surgery. Despite initial positive results, diet and exercise frequently prove futile for long-term management of weight loss. Likewise, it is uncommon for diabetic remission to be achieved through pharmaco-therapeutic agents, most of the medications designed to stabilize and improve diabetic control. This has led to the advent of interventional treatment for these conditions.
Bariatric surgery is the current gold-standard in the treatment of morbid obesity with recent evidence revealing that bariatric surgery is more effective than medical treatment for the long-term control of obese patients with type 2 diabetes. It is postulated that in addition to the restrictive effects associated with bariatric surgery, resection or disruption of the ghrelin producing regions of the stomach may play a significant role in eventual weight loss.
The primary source of blood flow to the fundus of the stomach, where the majority of ghrelin-producing cells are found, is the left gastric artery. This artery is commonly accessed percutaneously for the management of refractory upper gastrointestinal bleeding. Embolizations are typically well tolerated, therefore, it has been purported that selective embolization of this artery could induce adequate ischemia to the fundus resulting in a rapid decrease in ghrelin-producing cells along with its neurological and metabolic effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are bariatric surgical candidates; however, have refused surgery.
- •BMI between 35 and 40 with medical comorbidities
- •Patients who meet criteria for medical management of obesity with BMI ≥ 35
- •Age ≥ 18 years
- •Willing, able and mentally competent to provide written informed consent
排除标准
- •Age less than 18 years of age
- •Inability to lay supine on an angiographic table <500lbs due to table weight limits
- •Inappropriate anesthesia risk as determined by certified anesthesia provider.
- •Presence of a contraindication to endovascular therapy
- •Major surgery within the past eight weeks
- •Previous gastric, pancreatic, hepatic and splenic surgery
- •Previous radiation therapy to the left or right upper quadrant
- •Previous gastric, hepatic, or splenic embolization
- •Any history of portal venous hypertension
- •Severe renal impairment resulting in unacceptable risk of contrast-induced nephropathy
- •Pregnant or intend to become pregnant within one year
- •History of severe bleeding disorder (platelet count less than 40,000)
- •Allergy to materials in the embolic agents
- •Enrolled in another study
- •Any patient who has a history of allergic reaction to iodinated contrast
- •Abnormal baseline gastric emptying study
- •Patients taking anti-coagulants (anti-platelets fine)
- •Patients currently taking or requiring chronic use of non steroidal anti-inflammatory drugs (NSAID) or steroid medications
- •Patients with any chronic upper gastrointestinal complaints such as pain, nausea or vomiting
- •Patients with any history of peptic ulcer disease
- •Patients with any indication of gastrointestinal bleeding as documented by positive stool guaiac and complete blood count with abnormalities.
- •Subjects with mesenteric atherosclerotic disease or abdominal angina should be excluded due to safety concerns.
- •Patients with known aortic disease, such as dissection or aneurysm
- •Patients with comorbidities such as cancer
- •Patients with any abnormality on their baseline esophagogastroduodenoscopy (EGD)
- •Patients with a CT Angiogram demonstrating an anatomical variant in left gastric artery anatomy
- •Patients with any contraindications for monitored anesthesia care or general surgery
- •Patients with secondary causes of obesity such as Cushing's disease, hypothyroidism, or abnormal testosterone readings
- •Patients with active substance abuse or alcoholism
- •Patients with defined noncompliance with previous medical care
- •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.
结局指标
主要结局
Adverse Events
时间窗: 5 years
Safety outcomes involving the use of left gastric artery embolization
次要结局
- Change in Body mas index (BMI)(5 years)
- Percentage estimated body weight loss (EBWL)(5 years)
- Change in concentration of Ghrelin-producing cells(30 days post-operative)