Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms

Not Applicable

Completed

• Conditions: Myeloproliferative Neoplasms (MPN); Polycythemia Vera (PV); Essential Thrombocythemia (ET); Myelofibrosis (MF)
• Interventions: Procedure: Upper gastrointestinal endoscopy and Doppler ultrasound

• Registration Number: NCT01816256
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-22
• Study Start: 2013-05
• Primary Completion: 2019-03-11
• Study Completion: 2019-03-11
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 greater than 5 cm 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.
• Ability to understand and willing to sign a written consent form.
• Age 18 years or older at time of consent.

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
• Known history of active bleeding

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening tests	Upper gastrointestinal endoscopy and Doppler ultrasound	This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).

Primary Outcome Measures

Name	Time	Method
Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs)	6 years

Secondary Outcome Measures

Name	Time	Method
Identify the patient, disease and treatment related risk factors associated with PVT and PHTN	6 years
Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN	8 years

Trial Locations

Locations (2)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada