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

Recruiting

• Conditions: Portal Vein Thrombosis
• Interventions: Other: Observation

• Registration Number: NCT06513780
• Lead Sponsor: Ru-zhou Cai

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.

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 Timeline

• Study Start: 2016-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PVT	Observation	Participants who meet the inclusion criteria for portal vein thrombosis prior to liver transplantation
non-PVT	Observation	Participants who meet the inclusion criteria for the absence of portal vein thrombosis prior to liver transplantation.

Primary Outcome Measures

Name	Time	Method
Death	10 years	Rate of death from various causes after liver transplant
Postoperative portal vein thrombosis	10 years	Number of participants with portal vein thrombosis after liver transplant
Postoperative portal vein stenosis	10 years	Number of participants with portal vein stenosis after liver transplant

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	1 year	Rate of re-surgery, interventional operation, endoscopy, dialysis, etc.

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China