Image-guided Bariatric Arterial Embolization (BAE) for the Treatment of Obesity

图像引导肥胖动脉栓塞术 (BAE) 治疗肥胖症

• 批准号: 8651916
• 负责人: DARA L KRAITCHMAN
• 金额: $ 33.39万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8651916
• 关键词: Acute; Address; Adverse effects; Affect; American; Anatomy; Animal Model; Animals; Architecture; Arterial Embolization; Arteries; Bariatrics; Biliary; Blood Vessels; Body Weight decreased; Body fat; Body mass index; Catheters; Cells; Clinic; Clinical; Data; Desire for food; Devices; Diabetes Mellitus; Diagnostic radiologic examination; Disease; Eating; Effectiveness; Endocrine; Endocrine Glands; Family suidae; Feeling; Food; Fundus; Gastric mucosa; Goals; Health; Healthcare; Heart Diseases; Hormones; Human; Hunger; Image; Imaging Techniques; Incidence; Injection of therapeutic agent; Injury; Intervention; Intestines; Left; Leptin; Life; Liver; Maintenance; Malignant Neoplasms; Maps; Methods; Modeling; Morbid Obesity; Nature; Obesity; Operative Surgical Procedures; Overweight; Pancreas; Patients; Penetration; Perioperative complication; Pharmaceutical Preparations; Phase I Clinical Trials; Prevalence; Procedures; Production; Reflux; Resolution; Risk; Risk Factors; Roentgen Rays; Role; Safety; Signal Transduction; Spinal Diseases; Spleen; Stomach; Structure; System; Techniques; Technology; Testing; Therapeutic Agents; Therapeutic Embolization; Time; Toxic effect; Translating; Translations; Ulcer; United States; Vascular Diseases; Weight; Weight Gain; cancer therapy; cone-beam computed tomography; cost; energy balance; gastric artery; gastric fundus; ghrelin; glucagon-like peptide; image guided intervention; image guided therapy; improved; instrumentation; joint stress; minimally invasive; novel; obesity treatment; palliative; public health relevance; reconstruction; success; targeted delivery; tyrosyltyrosine

DESCRIPTION (provided by applicant): Approximately 127 million (65%) Americans are overweight, obese, or morbidly obese, and the number of obese Americans is rising. Obesity negatively affects general health and has been attributed to an increasing incidence of diabetes, heart disease, vascular disease, joint stress, lumbar spine disorders, liver and biliary disease, and various cancers. Currently, there are no image-guided or percutaneous interventions or alternatives to the current invasive surgical techniques for the morbidly obese. Moreover, these surgical approaches have variable success rates, are highly invasive (requiring reconstruction of bowel), and can have significant complications. Thus, a critical need exists for minimally invasive bariatric procedures to reduce the perioperative complication rate and cost of bariatric therapy. A potent endogenous hunger stimulant, ghrelin, which is principally produced in the gastric fundus, has been a target for weight loss. No clinically viable, non-surgical approaches to modulate ghrelin production have been developed to-date. However, our group has manipulated ghrelin levels and altered weight gain via embolization of the arterial supply to the fundus of the stomach in pigs. Bariatric gastric Artery Embolization (BAE) is a complicated procedure as multiple vessels supply the stomach, and branches of these same vessels supply multiple other key structures, such as the spleen, pancreas, and liver. Thus, the risk of non-target embolization of these key structures as well as injury or ulceration to the gastric mucosa is a concern. Unlike embolic therapy for cancer which is primarily palliative, if successful BAE could allow patients to lose weight, lower risk factors for other diseases, and live long productiv lives. Thus, critical issues such as improved targeting, safety, and long term efficacy need to be further addressed in order to translate this procedure from the swine model into patients. In this proposal, we will improve BAE using advances in technology including specialized injection devices, X-ray visible embolic beads, and state-of-the-art X-ray imaging systems in order to produce a more complete fundal embolization with fewer adverse effects from non-target embolization and mucosal damage. Through this we hope to achieve prolonged ghrelin suppression and sustained weight loss. Our Specific Aims include: 1) Improved targeting of the gastric fundus using X-ray visible embolic beads of varying sizes, cone beam CT, and an anti-reflux embolic catheter; 2) Improved safety of BAE by assessing the effect of gastroprotective medications; and 3) determining the long term safety and efficacy of optimized BAE to both suppress ghrelin and alter weight.

描述（由申请人提供）：大约1.27亿（65％）的美国人超重，肥胖或肥胖，肥胖美国人的数量正在增加。肥胖对普通健康产生负面影响，并归因于糖尿病，心脏病，血管疾病，关节胁迫，腰椎疾病，肝脏和胆汁疾病的发生率的增加。当前，没有图像引导或经皮干预措施，也没有针对病态肥胖的当前侵入性手术技术的替代方法。此外，这些外科手术方法具有可变的成功率，具有高度侵入性（需要重建肠），并且可能有重大的并发症。因此，对最小侵入性的减肥手术的关键需要，以降低围手术期并发症率和减肥疗法成本。 主要是在胃眼底产生的有效的内源性饥饿刺激剂，它一直是体重减轻的靶标。尚未开发出临床上可行的，非手术的调节生产方法的方法。但是，我们的小组通过将动脉供应栓塞到猪的胃底，通过栓塞动脉供应来操纵生长素素水平，并改变了体重增加。减肥胃动脉栓塞（BAE）是一个复杂的程序，因为多个容器提供胃，这些同一血管的分支提供了多个其他关键结构，例如脾脏，胰腺和肝脏。因此，这些关键结构的非目标栓塞以及胃粘膜损伤或溃疡的风险是一个问题。与癌症的栓塞疗法不同，它主要是姑息治疗的，如果成功的BAE可以使患者减轻体重，降低其他疾病的危险因素，并长期生效。因此，需要进一步解决关键问题，例如改善的靶向，安全性和长期疗效，以便将猪模型转化为患者。 在这个 提案，我们将使用技术的进步来改善BAE，包括专门的注射装置，X射线可见栓塞珠和最先进的X射线成像系统，以产生更完整的基本栓塞性，而非target栓塞和粘膜损害的不利影响较小。通过此，我们希望能够长期抑制生长素释放和持续的体重减轻。我们的具体目的包括：1）使用X射线尺寸可见的栓塞珠，锥形束CT和抗反复栓塞导管的X射线眼底靶向； 2）通过评估胃保护药物的影响来提高BAE的安全性； 3）确定优化的BAE的长期安全性和功效既抑制生长素释放蛋白和改变体重。