Anticoagulation in Gastroesophageal Varices and JAK2 Mutation

Myeloproliferative Neoplasm Clinical Trial

Official title:

Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04527666
• Other study ID #: ZS-ANTICO-JAK2
• 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: Xiaoquan HUANG, Ph.D
• Phone: 18801733835
• Email: huang.xiaoquan[@]zs-hospital.sh.cn
• 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. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female patients aged 18-75

• diagnosed as portal hypertension by contrast-enhanced computed tomography

• diagnosed as JAK2 positive

Exclusion Criteria:

• not had portal contrast-enhanced computed tomography

• not had JAK2 mutation test

• 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
• JAK2 Mutation
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Varicose Veins

Intervention

Drug:
• Anticoagulation Agents
Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

References & Publications (4)

Greenfield G, McMullin MF. Splanchnic venous thrombosis in JAK2 V617F mutation positive myeloproliferative neoplasms - long term follow-up of a regional case series. Thromb J. 2018 Dec 19;16:33. doi: 10.1186/s12959-018-0187-z. eCollection 2018. — View Citation

Magaz M, Alvarez-Larrán A, Colomer D, López-Guerra M, García-Criado MÁ, Mezzano G, Belmonte E, Olivas P, Soy G, Cervantes F, Darnell A, Ferrusquía-Acosta J, Baiges A, Turon F, Hernández-Gea V, García-Pagán JC. Next generation sequencing in the diagnosis of non-cirrhotic splanchnic vein thrombosis. J Hepatol. 2020 Jul 14. pii: S0168-8278(20)30456-6. doi: 10.1016/j.jhep.2020.06.045. [Epub ahead of print] — View 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 — 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(1):e1-5. doi: 10.1016/j.clml.2014.04.004. Epub 2014 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of portal vein thrombosis	The changes of portal vein thrombosis including progression, disappear or unchanged.	1 year
Secondary	The occurrence of variceal bleeding	The occurrence of variceal bleeding including haematemesis and melena	1 year
Secondary	Overall survival	Overall survival rate	1 year