A Study of the Correlation Between Portal Vein Thrombosis and Prognosis of Liver Transplantation

September 15, 2025 updated by: Ru-zhou Cai

The goal of this observational study is to investigate the correlation between portal vein thrombosis (PVT) and the prognosis of liver transplantation. The main questions it aims to address are:

What is the prevalence of PVT? What are the risk factors associated with PVT? What is the prognostic impact of preoperative PVT on liver transplantation?

Participants are divided into two groups: the PVT group and the non-PVT group. The investigators will comparatively analyze the data of both groups, estimate the prevalence and risk factors of PVT, construct a predictive model for PVT that is applicable in clinical settings, and clarify the prognostic effects of PVT.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to investigate the prevalence and risk factors of PVT, to develop a novel grading or rating system for PVT, and to explore the prognostic impact of preoperative PVT in liver transplantation.

The investigators will:

Recruit patients according to the inclusion/exclusion criteria and obtain signed informed consents. They will collect demographic and laboratory characteristics and classify patients into the PVT group and the non-PVT group based on preoperative ultrasound and/or computed tomography.

Collect patients' perioperative medical imaging, surgical procedures, pathology reports, postoperative treatments, follow-up data, and clinical endpoints.

Comparatively analyze the data of the PVT and non-PVT groups, estimate the prevalence and risk factors of PVT, construct a predictive model for PVT that is applicable in clinical settings, clarify the prognostic effects of PVT, and propose a grading/rating system for PVT.

Study Type

Observational

Enrollment (Estimated)

700

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
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent in situ liver transplantation at the Liver Transplantation Center of Beijing Friendship Hospital affiliated with Capital Medical University from 2016-1-1 to 2025-12-31

Description

Inclusion Criteria:

  1. Liver transplantation recipients
  2. Aged 18 years or older.

Exclusion Criteria:

  1. Retransplantation
  2. Multi-organ transplantation
  3. Portal vein tumor thrombus

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PVT
Participants who meet the inclusion criteria for portal vein thrombosis prior to liver transplantation
Other: Observation
No intervention were made.
non-PVT
Participants who meet the inclusion criteria for the absence of portal vein thrombosis prior to liver transplantation.
Other: Observation
No intervention were made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 10 years
Rate of death from various causes after liver transplant
10 years
Postoperative portal vein thrombosis
Time Frame: 10 years
Number of participants with portal vein thrombosis after liver transplant
10 years
Postoperative portal vein stenosis
Time Frame: 10 years
Number of participants with portal vein stenosis after liver transplant
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 1 year
Rate of re-surgery, interventional operation, endoscopy, dialysis, etc.
1 year

Collaborators and Investigators

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

Sponsor

Ru-zhou Cai

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)

January 1, 2016

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-P2-187-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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