- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07473375
Indicators Affecting PVT Recanalization
March 13, 2026 updated by: Shanghai Zhongshan Hospital
Indicators Affecting Portal Vein Thrombosis Recanalization in Cirrhosis With Gastroesophageal Varices
This is a retrospective-prospective study conducted at Zhongshan Hospital, Fudan University, to explore portal vein thrombosis (PVT) in patients with cirrhosis and gastroesophageal varices (GEV).
It aimed to provide insights into the diagnosis, follow-up, and factors influencing PVT recanalization, to help patients, families, and healthcare providers understand the disease and related clinical management.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
1500
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
- Name: Siyu Jiang, Dr.
- Phone Number: +86-15121068078
- Email: ksjsy1996926@126.com
Study Locations
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200032
- Recruiting
-
Contact:
- Siyu Jiang, Dr.
- Phone Number: +86 15121068078
- Email: ksjsy1996926@126.com
-
-
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
N/A
Sampling Method
Non-Probability Sample
Study Population
This study enrolled adult patients with cirrhosis and confirmed gastroesophageal varices who presented to Zhongshan Hospital, Fudan University, and were diagnosed with portal vein thrombosis (PVT)upon admission.
Description
Inclusion Criteria:
diagnosed as cirrhosis and confirmed gastroesophageal varices by endoscopy;
- all patients were diagnosed as PVT by CTA at admission.
Exclusion Criteria:
patients with hepatocellular carcinoma;
patients with extrahepatic malignancies;
history of liver transplantation or TIPS;
lack of information regarding anticoagulation therapy;
- those with cavernous transformation of the portal vein(CTPV) .
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PVT recanalization at 1 year
Time Frame: From the first abdominal imaging assessment after admission, until the occurrence of PVT recanalization at 1 year, death, or the last follow-up, whichever came first
|
From the first abdominal imaging assessment after admission, until the occurrence of PVT recanalization at 1 year, death, or the last follow-up, whichever came first
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurrence of all-cause death (competing event)
Time Frame: From the date of admission confirmation of PVT to the occurrence of death, or the last follow-up, whichever came first
|
From the date of admission confirmation of PVT to the occurrence of death, or the last follow-up, whichever came first
|
|
|
PVT recanalization at 5 years
Time Frame: From the first abdominal imaging assessment after admission, until the occurrence of PVT recanalization at 5 year, death, or the last follow-up, whichever came first
|
From the first abdominal imaging assessment after admission, until the occurrence of PVT recanalization at 5 year, death, or the last follow-up, whichever came first
|
|
|
Occurrence of non-improved PVT
Time Frame: From the date of admission confirmation of PVT to the last radiological follow-up at 1 year, or death, whichever came first
|
defined as unchanged thrombus size, <50% thrombus reduction, or thrombus extension to new venous segments
|
From the date of admission confirmation of PVT to the last radiological follow-up at 1 year, or death, whichever came first
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2017
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
March 11, 2026
First Submitted That Met QC Criteria
March 13, 2026
First Posted (Actual)
March 16, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSY-PVT-anticoagulation
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
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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