Gastroesophageal Varices in Cavernoma

• Conditions: Portal Caver Cavernoma; Gastroesophageal Varices; Portal Hypertension; Myeloproliferative Neoplasm
• Interventions: Diagnostic Test: JAK2 mutation test

• Registration Number: NCT04525768
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-23
• Last Update Submitted: 2020-08-23
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25
• Study Start: 2020-10-01
• Primary Completion: 2021-09-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JAK2 mutation Group	JAK2 mutation test	Patients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation.
Portal caver cavernoma Group	JAK2 mutation test	Patients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation.

Primary Outcome Measures

Name	Time	Method
History of variceal bleeding	1 day (the same time as diagnosis)	Have a history of the occurrence of gastroesophageal variceal bleeding

Secondary Outcome Measures

Name	Time	Method
1-year death rate	1 year	1-year death rate
Complications of portal hypertension	1 year	The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China