Clinical trial NCT02853526: TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV
Official title: Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis (PVT) and Cavernous Transformation of the Portal Vein (CTPV)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Portal Vein, Cavernous Transformation of
Portal Vein Thrombosis
Liver Cirrhosis
Bleeding Esophageal Varices
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Variceal rebleeding
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival time
timeFrame: 3 years
measure: Variceal rebleeding-related death rate
timeFrame: 3 years
measure: Treatment-related complications
timeFrame: 3 years
measure: Transjugular intrahepatic portosystemic shunt success rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiology
state: Guangdong
Study officials:
affiliation: Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University
name: Zaibo Jiang
role: PRINCIPAL_INVESTIGATOR
References: