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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 29 June 2014
Main ID:  ChiCTR-PRRC-08000228
Date of registration: 2008-12-14
Primary sponsor: Sun Yat-Sen University
Public title: Multicenter clinical trial of transjugular intrahepatic portosystemic shunt creation in the management of cirrhosis and portal hypertension
Scientific title: Multicenter clinical trial of transjugular intrahepatic portosystemic shunt creation in the management of cirrhosis and portal hypertension
Date of first enrolment: 2008-05-01
Target sample size: Group A:100;Group B:300;
Recruitment status: Recruiting
URL:  http://www.chictr.org/en/proj/show.aspx?proj=1162
Study type:  Prognose study
Study design:  Randomized parallel control  
Countries of recruitment
China
Contacts
Name: Huang Yonghui 
Address:  The First Affiliated Hospital of Sun Yat-sen University 510080
Telephone: +86 0 13802543290
Email: cjr.yangjianyong@vip.163.com
Affiliation: 
Name: Yang Janyong 
Address:  The First Affiliated Hospital of Sun Yat-sen University 510080
Telephone: +86 0 13802543290
Email: cjr.yangjianyong@vip.163.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum: 20
Age maximum: 80
Gender: Male
Health Condition(s) or Problem(s) studied
Cirrhosis, Portal Hypertension, esophagus-gastric fundus varicose, massive hemorrhage of gastrointestinal tract
ICD:K70.9
Intervention(s)
Group A:TIPSS;Group B:patients who are randomly allocated to pharmacological therapy, endoscope therapy, surgical shunt, surgical disconnection.;
Primary Outcome(s)
the incidence of control bleeding, the incidence of rebleeding;
Secondary Outcome(s)
Survival quality;Economic index;Technical success rate;Liver function;Complications;
Secondary ID(s)
Source(s) of Monetary Support
Sun Yat-Sen University Clinical Trial 5010 Project
Secondary Sponsor(s)
The First Affiliated Hospital of Sun Yat-Sen University
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