NCT07473375

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2017

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 Progress78%
Jan 2017Dec 2028

Study Start

First participant enrolled

January 1, 2017

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

11 years

First QC Date

March 11, 2026

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • PVT recanalization at 1 year

    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 Outcomes (3)

  • Occurrence of all-cause death (competing event)

    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

    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

    From the date of admission confirmation of PVT to the last radiological follow-up at 1 year, or death, whichever came first

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • diagnosed as cirrhosis and confirmed gastroesophageal varices by endoscopy;
  • all patients were diagnosed as PVT by CTA at admission.

You may not qualify if:

  • 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) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

FibrosisHypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start

January 1, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations