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研究实施负责（组长）单位：
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中山大学
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Primary sponsor：
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Sun Yat-Sen University
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研究实施负责（组长）单位地址：
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广东省广州市新港西路135号
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Primary sponsor's address：
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No.135, West Xingang Road, Guangzhou, Guangdong, China
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试验主办单位(项目批准或申办者)：
Secondary sponsor：
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国家：
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省(直辖市)：
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市(区县)：
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Country：
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Province：
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City：
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单位(医院)：
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中山大学附属第一医院
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具体地址：
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广东省广州市中山二路58号
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Institution
hospital：
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The First Affiliated Hospital of Sun Yat-Sen University
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Address：
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No.58, 2nd.Zhongshan Road,Guangzhou City
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经费或物资来源：
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中山大学和中山大学附属第一医院联合支付
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Source(s) of funding：
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Sun Yat-Sen University Clinical Trial 5010 Project
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研究疾病：
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肝硬化、门静脉高压、食道胃底静脉曲张、消化道大出血
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Target disease：
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Cirrhosis, Portal Hypertension, esophagus-gastric fundus varicose, massive hemorrhage of gastrointestinal tract
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研究疾病代码：
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ICD:K70.9
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Target disease code：
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研究类型：
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预后研究
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Study type：
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Prognose study
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研究所处阶段：
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II期临床试验
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Study phase：
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Phase II
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研究目的：
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1、 获得TIPSS术和内外科各治疗方案在症状缓解、术后并发症、复发和生存质量，生存率等方面的远期比较结果。
2、 确立一种非侵入性的肝血流量检测手段，为TIPSS的个体化分流及预测术后肝性脑病的发生提供可靠的依据。
3、 获得肝硬化门脉高压症不同治疗方法的可靠的经济学评价结果，为政府社会保障和医疗决策部门制定相关决策提供客观的科学依据。
4、 制定较成熟的肝硬化门脉高压症治疗的规范化、个体化的临床指南。
5、 根据肝硬化门脉高压症的不同分类提出国人"规范化防治"，"个体化防治"的新策略。
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Objectives of Study：
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1.To acquire comparisons of the release, postoperative complication, recurrence, and survival quality, survival rate between TIPSS and other therapies of surgery and medicine at distant stage; 2.To establish an approach to detect liver blood flow, which can provide reliable evidence on individual shunt and prediction of postoperative hepatic encephalopathy; 3.To acquire the reliable economical index of various treatments on cirrhosis portal hypertension, which can provide a serials of objective evidences for government and social security; 4.To enact well-rounded individual and normalized guideline for cirrhosis and portal hypertension; 5. To propose individual and normalized novel strategy according to classfication of cirrhosis and portal hypertension in China.
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研究设计：
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随机平行对照
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Study design：
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Randomized parallel control
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纳入标准：
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临床资料：肝硬化失代偿期，脾功能亢进，食道胃底静脉中重度曲张伴或不伴上消化道出血，肝功能Child A到C级；影像学依据：:术前常规门静脉系统B超、CT或核磁共振所见示：脾静脉主干直径大于0.8cm，脾大，肝叶比例失调，增生结节，可以恶性病灶≤3CM，无门脉系统血栓形成。有病理学或充足临床检验资料支持为肝硬化并伴有门静脉高压的病例。预计寿命在半年以上，无妊娠；适合手术、内镜、介入治疗的患者。所有病人入选时应签署知情同意书。
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Inclusion criteria
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stage of cirrhosis decompesation, hypersplenia, gastric and esophageal medium and serious variceal bleeding, with or without upper gastrointestinal hemorrhage, liver function Child Pugh class A-C. Imaging evidences on preoperative ultrasound, CT, MR are routinely used to appraise the presence of that diameter of portal trunk is over 0.8 cm, splenomeglia, hepatic lobes disproportion, node hyperplastic nodule, malignant lesion≤3cm,without portal vein thrombosis using for portal vein. cirrhosis with portal hypertension by pathology and adequate clinical laboratory. Predict survival is over half one year, no gravidity, patients who are suit to operation, endoscope, interventional treatment. writing informed consent of each subject.
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排除标准：
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多囊肝、门静脉海绵样变、门静脉癌栓、肝昏迷前期患者。不能或不愿签知情同意书者。孕妇，哺乳妇女，及未采取有效避孕措施的有可能再次生育的病人；临床上有明显精神异常，有中枢神经系统异常的病史或有发作史；心电图异常或临床上有明显的心脏病，如：充血性心衰，有症状的冠心病，心律失常，临床表现明显的心脏病，或过去12个月发作过心肌缺血；最近5年之内出现其他部位的恶性肿瘤；脑、肺、骨转移或腹腔淋巴结转移的病人或其他终末期疾病者。正参加其它临床试验的患者；以及研究人员认为其他原因不适合临床试验者。
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Exclusion criteria：
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polycystic liver disease, cavernous transformation of portal vein, portal vein cancer thrombin, hepatic precoma, inability or disagree to sign informed consent; pregnancy or women of childbearing potential not taking contraception; obvious mental anomaly, center nervous system abnormalities or history of attack; ECG abnormal or obvious heart disease in clinically as congestive heart failure, symptomatic coronary heart disease, arrhythmia, myocardial ischemia occurring within last 12 months. Malignant tumor occurring on any other locations within last 5 years; brain, lung, bone metastasis or terminal; patients who are receiving other clinical trial or unsuitable of clinical trail due to other causes by researcher.
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研究实施时间：
Study execute time：
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从From2008-1-1至To
2018-1-1
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