ChiCTR-TCH-08000289Completed治疗新技术临床试验
不同病变类型的布加氏综合症的介入治疗选择及疗效评价
自筹1 site in 1 country370 target enrollmentStarted: December 15, 2008Last updated:
Trial Snapshot
- Phase
- 治疗新技术临床试验
- Status
- Completed
- Sponsor
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- PTA 前后静脉压力数值,PTA 前后狭窄或闭塞处管腔或支架的直径和血流速度,支架位置及通畅情况,B 超、CT、MRI,生存率
Study Overview
Brief Summary
探讨慢性布加氏综合症介入治疗选择及临床疗效
Study Design
- Study Type
- 观察性研究
- Primary Purpose
- 队列研究
- Masking
- 无
Eligibility Criteria
- Ages
- 18 to 72 (—)
- Sex
- All
Inclusion Criteria
- •1)患者于山东省立医院消化内科、血管外科、肝胆外科及医学影像研究所治疗; 2)影像学检查及临床表现可确诊为布加氏综合征; 3)患者签手术知情同意书。
Exclusion Criteria
- •1)合并肝癌及其他肿瘤性疾病患者; 2) 非布加氏综合征引起的肝硬化及门静脉高压; 3) 排除其他引起的体循环淤血疾病; 4)有严重的心、脑、肾疾病患者,妊娠或哺乳期的病人
Arms & Interventions
肝静脉组
由肝静脉闭塞引起的 BCS 入组,根据不同病变部位采用不同经股静脉或经股静脉-颈静脉联合及其他多途径穿刺入路行球囊扩张成形术(PTA)和(或)内支架植入术
下腔静脉组
由下腔静脉闭塞引起的 BCS 入组,影像学检查证实有血栓者,行经导管取栓或溶栓治疗,血栓取出或溶解后再行球囊扩张成形术(PTA);下腔静脉膜性阻塞者行 PTA 术;下腔静脉节段性阻塞或球囊扩张后再狭窄者行 PTA+支架植入术
Outcomes
Primary Outcomes
PTA 前后静脉压力数值,PTA 前后狭窄或闭塞处管腔或支架的直径和血流速度,支架位置及通畅情况,B 超、CT、MRI,生存率
Secondary Outcomes
- 实验室检查
- 临床表现
Investigators
Study Sites (1)
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