Clinical trial NCT04525768: Gastroesophageal Varices in Cavernoma
Official title: Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Varices
Myeloproliferative Neoplasm
Portal Caver Cavernoma
Portal Hypertension
Keywords: portal hypertension
gastroesophageal varices
jak2 mutation
myeloproliferative Neoplasm
portal caver cavernoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who diagnosed with portal cavernoma and gastric and/or esophageal varices and underwent JAK2 mutation test.

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.


Eligibility 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.

Primary outcomes:
measure: History of variceal bleeding
timeFrame: 1 day (the same time as diagnosis)
Secondary outcomes:
measure: 1-year death rate
timeFrame: 1 year
measure: Complications of portal hypertension
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
References:
citation: Reilly CR, Babushok DV, Martin K, Spivak JL, Streiff M, Bahirwani R, Mondschein J, Stein B, Moliterno A, Hexner EO. Multicenter analysis of the use of transjugular intrahepatic portosystemic shunt for management of MPN-associated portal hypertension. Am J Hematol. 2017 Sep;92(9):909-914. doi: 10.1002/ajh.24798. Epub 2017 Jul 26.
citation: Yan M, Geyer H, Mesa R, Atallah E, Callum J, Bartoszko J, Yee K, Maganti M, Wong F, Gupta V. Clinical features of patients with Philadelphia-negative myeloproliferative neoplasms complicated by portal hypertension. Clin Lymphoma Myeloma Leuk. 2015 Jan;15(1):e1-5. doi: 10.1016/j.clml.2014.04.004. Epub 2014 Jun 11.