Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

Summary

The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

Conditions

• Pulmonary Embolism
• Embolism
• Embolism and Thrombosis
• Vascular Diseases
• Cardiovascular Diseases
• Lung Diseases
• Respiratory Tract Diseases
• Cancer
• Diagnosis

Interventions

PROCEDURE

YEARS algorithm

Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, haemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level \<1.0 μg/mL (\<1000ng/mL), and in patients with ≥1 items and a D-dimer level \<0.5 μg/mL (\<500 ng/mL) a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA.

PROCEDURE

CTPA

Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Reinier de Graaf Groep

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Diakonessenhuis, Utrecht

  collaborator OTHER

• Amphia Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Tergooi Hospital

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Bernhoven Hospital

  collaborator OTHER

• Hôpital Louis Mourier

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Maasstad Hospital

  collaborator OTHER

• Flevo Ziekenhuis, Almere

  collaborator UNKNOWN

• Groene Hart Ziekenhuis

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Principal Investigators

• Menno Huisman, Pr · Leiden University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2025-08-23

Completion

2025-08-23

Countries

• Belgium
• France
• Italy
• Netherlands
• Spain
• Switzerland

Study Locations