Portal Vein, Cavernous Transformation of, Portal Vein Thrombosis, Liver Cirrhosis, Bleeding Esophageal Varices
Conditions
Brief summary
To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.
Detailed description
The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.
Interventions
PROCEDURETIPS
Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (p-TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.
DRUGPropranolol
Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.
PROCEDUREEndoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.
DRUGWarfarin
Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal.
Sponsors
Zaibo Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI. * History of variceal bleeding. * Liver cirrhosis. * Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L. * Albumin ≥2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit. * PT(Prothrombin time)-INR(international normalized ratio) \< 1.7.
Exclusion criteria
* Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator). * Company with malignant tumors in liver or other organs. * Patients with known severe dysfunction of heart, lung, brain or kidney. * Active bleeding. * Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy. * Uncontrolled infection. * Pregnancy and breastfeeding. * HIV infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variceal rebleeding | 3 years | Variceal rebleeding rate in 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival time | 3 years | — |
| Variceal rebleeding-related death rate | 3 years | — |
| Treatment-related complications | 3 years | Incidence of treatment-related complications |
| Transjugular intrahepatic portosystemic shunt success rate | 3 years | Technical success rate of transjugular intrahepatic portosystemic shunt |
Countries
China
Contacts
Primary ContactTao Pan
Backup ContactZaibo Jiang
Outcome results
None listed