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

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

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-PRRC-08000228
Enrollment
Unknown
Registered
2008-10-01
Start date
2008-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Portal Hypertension, esophagus-gastric fundus varicose, massive hemorrhage of gastrointestinal tract

Interventions

Group A:TIPSS
Group B:patients who are randomly allocated to pharmacological therapy, endoscope therapy, surgical shunt, surgical disconnection.

Sponsors

Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 80 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
the incidence of control bleeding, the incidence of rebleeding;

Secondary

MeasureTime frame
quality of life;Economic index;Technical success rate;Liver function;Complication;

Countries

China

Contacts

Public ContactYang Janyong
cjr.yangjianyong@vip.163.com+86 0 13802543290

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026