NCT06513780

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

July 8, 2024

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Death

    Rate of death from various causes after liver transplant

    10 years

  • Postoperative portal vein thrombosis

    Number of participants with portal vein thrombosis after liver transplant

    10 years

  • Postoperative portal vein stenosis

    Number of participants with portal vein stenosis after liver transplant

    10 years

Secondary Outcomes (1)

  • Postoperative complications

    1 year

Study Arms (2)

PVT

Participants who meet the inclusion criteria for portal vein thrombosis prior to liver transplantation

Other: Observation

non-PVT

Participants who meet the inclusion criteria for the absence of portal vein thrombosis prior to liver transplantation.

Other: Observation

Interventions

No intervention were made.

PVTnon-PVT

Eligibility Criteria

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

You may qualify if:

  • Liver transplantation recipients
  • Aged 18 years or older.

You may not qualify if:

  • Retransplantation
  • Multi-organ transplantation
  • Portal vein tumor thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Ru-zhou Cai, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 22, 2024

Study Start

January 1, 2016

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations