Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis

February 22, 2023 updated by: Xingshun Qi, General Hospital of Shenyang Military Region

Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study

The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

475

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 Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • Department of Gastroenterology, General Hospital of Shenyang Military Area

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population should be the patients with a diagnosis with liver cirrhosis who were admitted to the Department of Gastroenterology of General Hospital of Shenyang Military Area.

Description

Inclusion Criteria:

  1. A diagnosis of liver cirrhosis.
  2. Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
  3. Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
  4. Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated.

Exclusion Criteria:

  1. Non-cirrhotic patients.
  2. Malignancy.
  3. Contrast-enhanced CT scans were neither feasible nor available.
  4. Severe cardiopulmonary diseases.
  5. Severe infectious diseases.
  6. Pregnant or breastfeeding.
  7. Allergic to contrast agents.
  8. Poor adherence.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 6-24 months
6-24 months
First bleeding
Time Frame: 0-24 months
As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.
0-24 months
Recurrent bleeding
Time Frame: 0-24 months
As for the patients with a prior history of bleeding, the recurrent bleeding was observed.
0-24 months
Treatment failure rate of acute variceal bleeding
Time Frame: 5 days
As for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed.
5 days

Collaborators and Investigators

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

Sponsor

General Hospital of Shenyang Military Region

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)

December 1, 2014

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 8, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVT-LC Prognosis

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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