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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02853526
Other study ID # TIPSVRDORNO3HSYSU
Secondary ID
Status Recruiting
Phase Phase 3
First received July 24, 2016
Last updated July 29, 2016
Start date July 2015
Est. completion date December 2018

Study information

Verified date July 2016
Source Sun Yat-sen University
Contact Tao Pan
Phone 8602085252066
Email pant5@mail2.sysu.edu.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
TIPS
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.
Drug:
Propranolol
Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.
Procedure:
Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.
Drug:
Warfarin
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.

Locations

Country Name City State
China Department of Radiology Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Zaibo Jiang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variceal rebleeding Variceal rebleeding rate in 3 years 3 years No
Secondary Overall survival time 3 years No
Secondary Variceal rebleeding-related death rate 3 years No
Secondary Treatment-related complications Incidence of treatment-related complications 3 years Yes
Secondary Transjugular intrahepatic portosystemic shunt success rate Technical success rate of transjugular intrahepatic portosystemic shunt 3 years No
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