NCT02485184

Brief Summary

portal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

July 9, 2017

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

7.5 years

First QC Date

June 23, 2015

Last Update Submit

October 22, 2022

Conditions

Portal Vein ThrombosisLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • All-cause rebleeding or all-cause death

    Cumulative incidence of all-cause rebleeding or all-cause death

    3 years

Secondary Outcomes (6)

  • Portal vein recanalization

    3 years

  • Other decompensations of portal hypertension

    3 years

  • adverse events of treatment

    3 years

  • Quality of life

    3 years

  • Overall survival

    3 years

  • +1 more secondary outcomes

Study Arms (2)

TIPS group

ACTIVE COMPARATOR

Transjugular intrahepatic portosystemic shunt

Procedure: Transjugular intrahepatic portosystemic shunt

ET & drugs groups

ACTIVE COMPARATOR

1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.

Drug: Non-selective beta blockersProcedure: Endoscopic therapyDrug: Anticoagulation

Interventions

Transjugular intrahepatic portosystemic shuntPROCEDURE

Transjugular intrahepatic portosystemic shunt refers to an interventional radiological procedure by placing a stent between portal vein and hepatic vein. No specific device was used in the Interventional field.

TIPS group
Non-selective beta blockersDRUG

Non-selective beta blockers are the drugs for reducing the portal pressure.

Also known as: propranolol
ET & drugs groups
Endoscopic therapyPROCEDURE

Endoscopic therapy includes the endoscopic variceal band ligation

ET & drugs groups
AnticoagulationDRUG

Anticoagulation therapy includes heparin and warfarin.

Also known as: warfarin
ET & drugs groups

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver cirrhosis (histological or clinical);
  • Significant variceal bleeding \>5 days and ≤ 42 days
  • Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
  • Portal vein thrombosis occlusion\>=25% of the vessel lumen;
  • Presence of ascites
  • Age 18 to 70 years

You may not qualify if:

  • Bleeding from isolated gastric or ectopic varices
  • Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
  • Contraindications to TIPS : extensive potral vein thrombosis, fibrotic cord replacing original main portal vein; bilirubin\>3.5 mg/dL, plasma creatinine\>2.1 mg/dL, Child-Pugh score \>=13points
  • A history of significant heart failure (New York Heart Association class III and IV)
  • Overt hepatic encephalopathy,
  • Prehepatic portal hypertension
  • Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
  • Uncontrolled infection and sepsis
  • Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

the First Affiliated Hospital, Air Force Medical University

Xi'an, Shaanxi, 710032, China

COMPLETED

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

RECRUITING

Nanfang Hospital Affiliated to Southern Medical Univers

Guangzhou, China

RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

RECRUITING

Provincial Hospital Affiliated to Shandong University

Jinan, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, China

RECRUITING

Related Publications (2)

  • Han G, Qi X, He C, Yin Z, Wang J, Xia J, Yang Z, Bai M, Meng X, Niu J, Wu K, Fan D. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis with symptomatic portal hypertension in liver cirrhosis. J Hepatol. 2011 Jan;54(1):78-88. doi: 10.1016/j.jhep.2010.06.029. Epub 2010 Aug 27.

    PMID: 20932597BACKGROUND

  • Lv Y, He C, Wang Z, Guo W, Wang J, Bai W, Zhang L, Wang Q, Liu H, Luo B, Niu J, Li K, Tie J, Yin Z, Fan D, Han G. Association of Nonmalignant Portal Vein Thrombosis and Outcomes after Transjugular Intrahepatic Portosystemic Shunt in Patients with Cirrhosis. Radiology. 2017 Dec;285(3):999-1010. doi: 10.1148/radiol.2017162266. Epub 2017 Jul 5.

    PMID: 28682164BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular IntrahepaticPropranololWarfarin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, SurgicalAnastomosis, SurgicalSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresCardiovascular Surgical ProceduresPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Guohong Han, MD

    Xi'an International Medical Center Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guohong Han, MD

CONTACT

86-1399196993013991969930@126.com

Yong Lv, MD

CONTACT

lvyong126@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 30, 2015

Study Start

July 9, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

CN(8)