Portal Vein ThrombosisNCT06513780
A Study of the Correlation Between Portal Vein Thrombosis and Prognosis of Liver Transplantation
An observational study of Portal Vein Thrombosis, run by Ru-zhou Cai at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis
- What is being tested?
- Observation
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Liver transplantation recipients
- Aged 18 years or older.
Who cannot join
- Retransplantation
- Multi-organ transplantation
- Portal vein tumor thrombus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Ruzhou Cai, 18722563616, 18722563616@126.com
About this study
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.
Read the 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.
- Conditions
- Portal Vein Thrombosis
- Being tested
- Observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention were made.
| Study group | Role | What they receive |
|---|---|---|
| PVT | Participants who meet the inclusion criteria for portal vein thrombosis prior to liver transplantation Receives: Other: Observation | |
| non-PVT | Participants who meet the inclusion criteria for the absence of portal vein thrombosis prior to liver transplantation. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Rate of death from various causes after liver transplant
Measured: 10 years
Postoperative portal vein thrombosis
Number of participants with portal vein thrombosis after liver transplant
Measured: 10 years
Postoperative portal vein stenosis
Number of participants with portal vein stenosis after liver transplant
Measured: 10 years
Secondary outcomes (1)
Postoperative complications
Rate of re-surgery, interventional operation, endoscopy, dialysis, etc.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ru-zhou Cai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ru-zhou Cai, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513780
- Sponsor's protocol ID
- 2024-P2-187-01
- Status last verified
- Sep 2025
- First submitted
- 8 Jul 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Correlation Between Portal Vein Thrombosis and Prognosis of Liver Transplantation
- ClinicalTrials.gov ID
- NCT06513780
- Acronym / sponsor ID
- 2024-P2-187-01
- Conditions
- Portal Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Ru-zhou CaiUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVT | – | Other: ObservationParticipants who meet the inclusion criteria for portal vein thrombosis prior to liver transplantation |
| non-PVT | – | Other: ObservationParticipants who meet the inclusion criteria for the absence of portal vein thrombosis prior to liver transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Liver transplantation recipients
- Aged 18 years or older.
Key exclusion criteria (3 listed)
- Retransplantation
- Multi-organ transplantation
- Portal vein tumor thrombus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo intervention were made. | Other | PVT, non-PVT |
Primary outcome
Death
Time frame: 10 years
Rate of death from various causes after liver transplant
Postoperative portal vein thrombosis
Time frame: 10 years
Number of participants with portal vein thrombosis after liver transplant
Postoperative portal vein stenosis
Time frame: 10 years
Number of participants with portal vein stenosis after liver transplant
1 secondary outcome
Postoperative complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Thrombosis, run by Ru-zhou Cai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ru-zhou Cai, M.D. (18722563616, 18722563616@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.