Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms
Conditions
Myeloproliferative Neoplasms (MPN) - Polycythemia Vera (PV) - Essential Thrombocythemia (ET) - Myelofibrosis (MF)
Conditions: official terms
Hypertension, Portal - Myeloproliferative Disorders - Neoplasms - Polycythemia - Polycythemia Vera - Primary Myelofibrosis - Thrombocythemia, Essential - Thrombocytosis - Venous Thrombosis
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: Upper gastrointestinal endoscopy and Doppler ultrasound
Type: Procedure
Overall Status
Recruiting
Summary
This study involves screening for portal vein thrombosis and portal hypertension in patients with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis.

Portal vein thrombosis and portal hypertension are serious complications that are often seen in myeloproliferative patients. These complications are usually diagnosed when patients become symptomatic, and are often already at an advanced stage. They can further progress to cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of this, patients often accumulate fluid in the abdomen which is ascites; and can develop swelling of veins in the lining of the esophagus known as varices. If untreated, varices have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced stage, the treatment is usually supportive therapy and there are no treatments available at present which can reverse these conditions.

This study is looking at screening for these two conditions using Doppler ultrasound and upper gastrointestinal endoscopy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) criteria

- Palpable spleen length >5 cms below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET.

Exclusion criteria:

- Known history of portal vein thrombosis

- Known history of Budd-chairi syndrome

- Known history of oesophageal varices

- Known history of cirrhosis from any cause
Location
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Status: Recruiting
Contact: Vikas Gupta, MD, FRCP - vikas.gupta@uhn.ca
Start Date
May 2013
Sponsors
University Health Network, Toronto
Source
University Health Network, Toronto
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page