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Interventional vascular occlusion treatment for varicose veins in lower extremity : in vivo assessment and development of clinical techniques

下肢静脉曲张的介入血管闭塞治疗：体内评估和临床技术的发展

基本信息

批准号：
15591306
负责人：
HOSAKA Junro
金额：
$ 1.47万
依托单位：
Nippon Medical School
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
2003
资助国家：
日本
起止时间：
2003 至 2004
项目状态：
已结题

项目摘要

First examination was carried out to determine principles of the interventional vascular occlusion treatment in acute and sub-acute phases. The epigastric vein in a pig was exposed, and a catheter and a laser fiber were inserted. Laser irradiation was performed from diaphragm level to insertion part. Venograms and pulmonary angiograms were obtained before and after treatment. Arterial blood pressure and arterial blood gas were measured repeatedly during examination. The treated vein was examined pathologically. The vein was blocked right after the irradiation. Arterial blood pressure and arterial blood gas did not change during examination, and pulmonary embolism was not recorded. Pathologically, destruction of vessel wall, perivascular edema and intravascular thrombotic occlusion were observed just after the irradiation. Two weeks later, vessel occlusion, degeneration of thrombus, change from granulation tissue to fibrous tissue, loss of elastic fiber and smooth muscle in vessel wall … More were observed. By this examination, the maneuver to insert a catheter and a laser fiber was established, and followings were confirmed ; local safety, no risk of pulmonary embolism, strong thrombotic occlusion of the vessel.Next examination was carried out to observe a natural course after the treatment up to 6 months, and to assess the effect of elastic bandage to prevent re-canalization of the treated vessel Continuation of vascular occlusion was confirmed for two months in pilot experiments, while remodeling of experimental protocol was needed because of high activity of the animal, difficulty to wear the elastic bandage continuously, and validity of pathological data obtained from an animal in growth process.On the other hand, there was a report with long-term observation from United States. On basis of this report, clinical application was started after approval by the ethical committee of our institute. Patients with varicose veins due to insufficient great saphenous vein were included in the study. Written informed consent was always obtained before the treatment. At present, complete obstruction of the great saphenous vein has been observed through all follow-up period (up to 8 months). No severe side effect, such as pulmonary embolism, was recorded.The results was presented many times from 2003 to 2005,both in Japan and in United States (Japan Radiological Society, AJR, Japanese Society of phlebology, etc), and it will be presented in Cardiovascular and Interventional Radiological Society of Europe in 2005. Less

首次明确急性期和亚急性期介入血管闭塞治疗的原则。暴露猪的上腹部静脉，插入导管和激光纤维。从隔膜水平到插入部分进行激光照射。治疗前后分别进行静脉造影和肺动脉造影。检查期间重复测量动脉血压和动脉血气。对经处理的静脉进行病理学检查。照射后静脉立即被堵塞。检查期间动脉血压和动脉血气无变化，未记录肺栓塞。光镜下可见照射后即刻血管壁破坏、血管周围水肿及血栓性闭塞。2周后血管闭塞，血栓变性，肉芽组织向纤维组织转变，血管壁弹性纤维和平滑肌缺失 ...更多信息观察了通过该检查，确立了插入导管和激光纤维的操作，并确认了以下内容：局部安全，没有肺栓塞的风险，血管的强烈血栓性闭塞。进行下一次检查以观察治疗后长达6个月的自然病程，并评估弹性绷带防止被治疗血管再通的效果在预试验中证实血管闭塞持续两个月，另一方面，美国有一份长期观察的报告。在此报告的基础上，经我院伦理委员会批准后开始临床应用。研究纳入了因大隐静脉不足而导致静脉曲张的患者。在治疗前始终获得书面知情同意书。目前，在所有随访期间（长达8个月）均观察到大隐静脉完全阻塞。2003年至2005年，在日本和美国（日本放射学会、AJR、日本静脉学会等）多次发表该结果，并将于2005年在欧洲心血管和介入放射学会发表。少