Gastroesophageal Varices in Cavernoma

Portal Hypertension Clinical Trial

Official title:

Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04525768
• Other study ID #: ZS-cavernoma-EGV
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2020
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastroesophageal Varices
• Hypertension
• Hypertension, Portal
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Portal Caver Cavernoma
• Portal Hypertension
• Varicose Veins

Intervention

Diagnostic Test:
• JAK2 mutation test
Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	History of variceal bleeding	Have a history of the occurrence of gastroesophageal variceal bleeding	1 day (the same time as diagnosis)
Secondary	1-year death rate	1-year death rate	1 year
Secondary	Complications of portal hypertension	The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)	1 year