Gastroesophageal Varices in Cavernoma

August 23, 2020 updated by: XiaoquanHUANG, Shanghai Zhongshan Hospital

Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. Portal vein thrombosis and portal cavernoma frequently occur in the MPN population and the management of gastroesophageal varices in these patients are sometimes technically difficult. The aim of this study is to investigate the the characteristics of patients with gastroesophageal varices and portal caver cavernoma with or without JAK2 mutation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • 180 Fenglin Road

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who diagnosed with portal cavernoma and gastric and/or esophageal varices and underwent JAK2 mutation test.

Description

Inclusion Criteria:

  • male or female patients aged 18-75
  • diagnosed as portal hypertension and portal cavernoma by contrast-enhanced computed tomography
  • underwent JAK2 mutation test

Exclusion Criteria:

  • combined known etiologies of chronic liver disease, including hepatitis, primary biliary cirrhosis, schistosomiasis, and non-alcoholic fatty liver disease.
  • other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
JAK2 mutation Group
Patients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation.
Diagnostic test: JAK2 mutation test
Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test
Portal caver cavernoma Group
Patients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation.
Diagnostic test: JAK2 mutation test
Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
History of variceal bleeding
Time Frame: 1 day (the same time as diagnosis)
Have a history of the occurrence of gastroesophageal variceal bleeding
1 day (the same time as diagnosis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year death rate
Time Frame: 1 year
1-year death rate
1 year
Complications of portal hypertension
Time Frame: 1 year
The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

October 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 23, 2020

First Posted (ACTUAL)

August 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-cavernoma-EGV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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