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Gastroesophageal Varices in Cavernoma

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ClinicalTrials.gov Identifier: NCT04525768
Recruitment Status : Not yet recruiting
First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
XiaoquanHUANG, Shanghai Zhongshan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastroesophageal Varices Myeloproliferative Neoplasm Portal Caver Cavernoma Portal Hypertension Diagnostic Test: JAK2 mutation test

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022


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




Primary Outcome Measures :
  1. History of variceal bleeding [ Time Frame: 1 day (the same time as diagnosis) ]
    Have a history of the occurrence of gastroesophageal variceal bleeding


Secondary Outcome Measures :
  1. 1-year death rate [ Time Frame: 1 year ]
    1-year death rate

  2. Complications of portal hypertension [ Time Frame: 1 year ]
    The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525768


Locations
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China, Shanghai
180 Fenglin Road
Shanghai, Shanghai, China, 200032
Contact: Xiaoquan HUANG, M.D.    +86-18801733835    huangxiaoquan1010@aliyun.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Publications of Results:
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Responsible Party: XiaoquanHUANG, Resident, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04525768    
Other Study ID Numbers: ZS-cavernoma-EGV
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XiaoquanHUANG, Shanghai Zhongshan Hospital:
portal hypertension
gastroesophageal varices
jak2 mutation
myeloproliferative Neoplasm
portal caver cavernoma
Additional relevant MeSH terms:
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Hemangioma, Cavernous
Hypertension, Portal
Esophageal and Gastric Varices
Hypertension
Varicose Veins
Myeloproliferative Disorders
Vascular Diseases
Cardiovascular Diseases
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Hemostatic Disorders
Hemorrhagic Disorders