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TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV

Primary Purpose

Portal Vein, Cavernous Transformation of, Portal Vein Thrombosis, Liver Cirrhosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

TIPS

Propranolol

Endoscopic therapy

Warfarin

About this trial

This is an interventional treatment trial for Portal Vein, Cavernous Transformation of

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of RadiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS arm

conservative treatment arm

Arm Description

Transjugular intrahepatic portosystemic shunt(TIPS) is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension.TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (also called p-TIPS or modified 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.

Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).

Outcomes

Primary Outcome Measures

Variceal rebleeding

Variceal rebleeding rate in 3 years

Secondary Outcome Measures

Overall survival time

Variceal rebleeding-related death rate

Treatment-related complications

Incidence of treatment-related complications

Transjugular intrahepatic portosystemic shunt success rate

Technical success rate of transjugular intrahepatic portosystemic shunt

Full Information

NCT ID

NCT02853526

First Posted

July 24, 2016

Last Updated

July 29, 2016

Sponsor

Zaibo Jiang

1. Study Identification

Unique Protocol Identification Number

NCT02853526

Brief Title

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

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zaibo Jiang

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Portal Vein, Cavernous Transformation of, Portal Vein Thrombosis, Liver Cirrhosis, Bleeding Esophageal Varices

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TIPS arm

Arm Type

Experimental

Arm Description

Arm Title

conservative treatment arm

Arm Type

Active Comparator

Arm Description

Conservative treatment including endoscopic therapy，non-selective beta blockers (propranolol)and anticoagulation therapy (warfarin).

Intervention Type

Procedure

Intervention Name(s)

TIPS

Other Intervention Name(s)

Transjugular intrahepatic portosystemic shunt

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propranolol

Intervention Description

Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.

Intervention Type

Procedure

Intervention Name(s)

Endoscopic therapy

Intervention Description

Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.

Intervention Type

Drug

Intervention Name(s)

Warfarin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Variceal rebleeding

Description

Variceal rebleeding rate in 3 years

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival time

Time Frame

3 years

Title

Variceal rebleeding-related death rate

Time Frame

3 years

Title

Treatment-related complications

Description

Incidence of treatment-related complications

Time Frame

3 years

Title

Transjugular intrahepatic portosystemic shunt success rate

Description

Technical success rate of transjugular intrahepatic portosystemic shunt

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Pan

Phone

8602085252066

pant5@mail2.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zaibo Jiang

Phone

8602085253416

jiangzaibo@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zaibo Jiang

Organizational Affiliation

Department of Intervention and Vascular Surgery, the Third Affiliated Hospital, Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Radiology

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510630

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zaibo Jiang, MD.

Phone

+86 020 85253416

jiangzaibo@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV

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