Multicenter clinical trial of transjugular intrahepatic portosystemic shunt creation in the management of cirrhosis and portal hypertension

• Register: ChiCTR
• Last refreshed on: 28 April 2013
• 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

• Name: Yang Janyong

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;

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