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

October 22, 2022 updated by: Guohong Han, Air Force Military Medical University, China

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Ming-an Li, MD
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital Affiliated to Southern Medical Univers
        • Contact:
          • Jianbo Zhao, MD
      • Jinan, China
        • Recruiting
        • Provincial Hospital Affiliated to Shandong University
        • Contact:
          • Chunqing Zhang, MD
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Xuan Zhu, MD
      • Nanjing, China
        • Recruiting
        • Affiliated Drum Tower Hospital of Nanjing University Medical School
        • Contact:
          • Yuzheng Zhuge, MD
      • Ürümqi, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Weixin Ren, MD
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Completed
        • the First Affiliated Hospital, Air Force Medical University
      • Xi'an, Shaanxi, China, 710100
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
        • Sub-Investigator:
          • Yong Lv, MD,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. liver cirrhosis (histological or clinical);
  2. Significant variceal bleeding >5 days and ≤ 42 days
  3. Successful treatment of the index bleed by means of vasoactive drugs and/or endoscopic treatment
  4. Portal vein thrombosis occlusion>=25% of the vessel lumen;
  5. Presence of ascites
  6. Child-Pugh score 8-12 at inclusion
  7. Age 18 to 70 years

Exclusion criteria

  1. Bleeding from isolated gastric or ectopic varices
  2. Contraindications to non-selective beta blockers (chronic obstructive pulmonary disease, asthma, aortic stenosis, atrioventricular block, intermittent claudication, and psychosis)
  3. 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
  4. A history of significant heart failure (New York Heart Association class III and IV)
  5. Overt hepatic encephalopathy,
  6. Prehepatic portal hypertension
  7. Malignancy (including hepatocellular carcinoma) or a concomitant disease with reduced life expectancy
  8. Uncontrolled infection and sepsis
  9. Previous treatment to prevent rebleeding with a portosystemic shunt,TIPS or with pharmacological therapy with non-selective beta blockers and endoscopic variceal ligation
  10. Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TIPS group
Transjugular intrahepatic portosystemic shunt
Procedure: Transjugular intrahepatic portosystemic shunt
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.
Active Comparator: ET & drugs groups
  1. Endoscopic therapy.
  2. Non-selective beta blockers.
  3. Anticoagulation therapy.
Drug: Non-selective beta blockers
Non-selective beta blockers are the drugs for reducing the portal pressure.
Other Names:
  • propranolol
Procedure: Endoscopic therapy
Endoscopic therapy includes the endoscopic variceal band ligation
Drug: Anticoagulation
Anticoagulation therapy includes heparin and warfarin.
Other Names:
  • warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause rebleeding or all-cause death
Time Frame: 3 years
Cumulative incidence of all-cause rebleeding or all-cause death
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal vein recanalization
Time Frame: 3 years
Incidence of portal vein recanalization
3 years
Other decompensations of portal hypertension
Time Frame: 3 years
defined as ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome
3 years
adverse events of treatment
Time Frame: 3 years
Incidence of adverse events of treatment
3 years
Quality of life
Time Frame: 3 years
quality of life assessed by the SF-36 health survey
3 years
Overall survival
Time Frame: 3 years
Overall survival rate
3 years
Hepatocellular Carcinoma
Time Frame: 3 years
Incidence of Hepatocellular Carcinoma
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Collaborators

The First Affiliated Hospital of Nanchang University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shandong Provincial Hospital
Third Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Xinjiang Medical University
Southern Medical University, China

Investigators

  • Principal Investigator: Guohong Han, MD, Xi'an International Medical Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2017

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 22, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT-TIPS2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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