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Portal Vein ThrombosisNCT02485184

TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis

A study testing Transjugular intrahepatic portosystemic shunt, Non-selective beta blockers and Endoscopic therapy in people with Portal Vein Thrombosis and Liver Cirrhosis, run by Air Force Military Medical University, China at 8 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Portal Vein Thrombosis, Liver Cirrhosis
What is being tested?
Transjugular intrahepatic portosystemic shunt, Non-selective beta blockers and Endoscopic therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
8 sitesChina
Study dates
9 Jul 2017to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Child-Pugh score 8-12 at inclusion
  • Age 18 to 70 years

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

Guohong Han, MD contact

86-13991969930

13991969930@126.com

Yong Lv, MD contact

lvyong126@126.com

8 sites in 1 country

China8 sites, 7 recruiting

  • Nanfang Hospital Affiliated to Southern Medical Univers

    Guangzhou

    Jianbo Zhao, MD

    Recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Ming-an Li, MD

    Recruiting

  • Provincial Hospital Affiliated to Shandong University

    Jinan

    Chunqing Zhang, MD

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Xuan Zhu, MD

    Recruiting

  • Affiliated Drum Tower Hospital of Nanjing University Medical School

    Nanjing

    Yuzheng Zhuge, MD

    Recruiting

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

    Weixin Ren, MD

    Recruiting

  • the First Affiliated Hospital, Air Force Medical University

    Xi'an, Shaanxi, 710032

    Completed

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710100

    Guohong Han, MD,Ph.D, 13991969930@126.com

    Guohong Han, MD,Ph.D

    Recruiting

Other trials in China

About this study

Official title: TIPS Versus Endoscopic Therapy for the Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial

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.

Read the detailed description

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. However, the safety of transjugular intrahepatic portosystemic shunt remains uncertain in patients with portal vein thrombosis.

Being tested
Transjugular intrahepatic portosystemic shunt, Non-selective beta blockers, Endoscopic therapy, Anticoagulation
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transjugular intrahepatic portosystemic shuntProcedure or surgery

    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.

  • Non-selective beta blockersDrug

    Also called propranolol

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

  • Endoscopic therapyProcedure or surgery

    Endoscopic therapy includes the endoscopic variceal band ligation

  • AnticoagulationDrug

    Also called warfarin

    Anticoagulation therapy includes heparin and warfarin.

Study groups in NCT02485184
Study groupRoleWhat they receive
TIPS groupActive comparatorTransjugular intrahepatic portosystemic shunt
Receives: Procedure: Transjugular intrahepatic portosystemic shunt
ET & drugs groupsActive comparator1. Endoscopic therapy. 2. Non-selective beta blockers. 3. Anticoagulation therapy.
Receives: Drug: Non-selective beta blockers; Procedure: Endoscopic therapy; Drug: Anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause rebleeding or all-cause death

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

    Measured: 3 years

Secondary outcomes (6)

  1. Portal vein recanalization

    Incidence of portal vein recanalization

    Measured: 3 years

  2. Other decompensations of portal hypertension

    defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome

    Measured: 3 years

  3. adverse events of treatment

    Incidence of adverse events of treatment

    Measured: 3 years

  4. Quality of life

    quality of life assessed by the SF-36 health survey

    Measured: 3 years

  5. Overall survival

    Overall survival rate

    Measured: 3 years

  6. Hepatocellular Carcinoma

    Incidence of Hepatocellular Carcinoma

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2015 (estimated)
  2. Study start9 Jul 2017
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02485184
Sponsor's protocol ID
PVT-TIPS2
Status last verified
Oct 2022
First submitted
23 Jun 2015
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20932597

  • 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.

    PubMed 28682164

Questions about this trial

What is this clinical trial studying?

A study testing Transjugular intrahepatic portosystemic shunt, Non-selective beta blockers and Endoscopic therapy in people with Portal Vein Thrombosis and Liver Cirrhosis, run by Air Force Military Medical University, China at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guohong Han, MD (86-13991969930, 13991969930@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause rebleeding or all-cause death (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02485184, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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