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

NCT ID: NCT04657120

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Recently, the YEARS-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE) may not be as effective and safe in patients with malignancy, due to the low specificity of D-dimer test in that setting. A diagnostic algorithm that could safely rule out PE in patients with malignancy without performing computed tomography pulmonary angiography (CTPA) could nonetheless improve patient care.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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YEARS algorithm

Patients randomized to this arm will be evaluated according to the YEARS algorithm.

Group Type EXPERIMENTAL

YEARS algorithm

Intervention Type PROCEDURE

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.

CTPA as single test

Patients randomized to this arm will undergo a contrast enhanced CTPA.

Group Type ACTIVE_COMPARATOR

CTPA

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

CTPA

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Clinically suspected PE as judged by the treating clinician
* Any type of active malignancy (other than basal-cell or squamous-cell carcinoma of the skin), defined as diagnosis within six months before the study inclusion (as confirmed histologically or high suspicion as judged by the clinician), receiving treatment for malignancy at time of inclusion or during 6 months prior to randomization, including recurrent or local metastatic malignancy
* Outpatients and hospitalized patients
* Age ≥ 18 years
* Signed and dated informed consent, available for start of the trial procedure

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 3 months, or unwillingness to sign informed consent
* Treatment with full-dose therapeutically dosed anticoagulation that was initiated 24 hours or more prior to eligibility assessment
* Contraindication to CTPA

* contrast allergy

Hemodynamic instability at presentation (as a consequence of concurrent acute PE or otherwise), indicated by at least one of the following:

* systolic blood pressure (SBP) \< 100 mm Hg, or heart rate \>120 beats per minute or SBP drop by \> 40 mm Hg, for \> 15 min
* need for catecholamines to maintain adequate organ perfusion and a systolic blood pressure of \> 100 mmHg
* Need for cardiopulmonary resuscitation
* Inability to follow-up
* Life expectancy less than 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily MARTENS, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Antwerpen University Hospital (UZA)

Antwerp, , Belgium

Site Status RECRUITING

Cliniques Universitaires Saint-Luc (CUSL)

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Liège (CHU Liège)

Liège, , Belgium

Site Status NOT_YET_RECRUITING

CHU Brest

Brest, , France

Site Status RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Hôpital Louis Mourier - APHP

Colombes, , France

Site Status NOT_YET_RECRUITING

HEGP

Paris, , France

Site Status NOT_YET_RECRUITING

CHU Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Policlinico di Milano Ospedale Maggiore | Fondazione IRCCS Ca' Granda

Milan, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Flevoziekenhuis

Almere Stad, , Netherlands

Site Status RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Rijnstate Ziekenhuis

Arnhem, , Netherlands

Site Status NOT_YET_RECRUITING

Amphia Ziekenhuis

Breda, , Netherlands

Site Status RECRUITING

Reinier de Graaf Gasthuis

Delft, , Netherlands

Site Status RECRUITING

Groene Hart Ziekenhuis

Gouda, , Netherlands

Site Status RECRUITING

Tergooi MC

Hilversum, , Netherlands

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

Radboud UMC

Nijmegen, , Netherlands

Site Status RECRUITING

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Site Status RECRUITING

Haaglanden Medisch Centrum

The Hague, , Netherlands

Site Status RECRUITING

Bernhoven Ziekenhuis

Uden, , Netherlands

Site Status RECRUITING

Diakonessenhuis

Utrecht, , Netherlands

Site Status RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status RECRUITING

The Inselspital Bern

Bern, , Switzerland

Site Status RECRUITING

Hôpitaux Universitaires de Genève (HUG)

Geneva, , Switzerland

Site Status RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Belgium France Italy Netherlands Spain Switzerland

Central Contacts

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Emily MARTENS, MD

Role: CONTACT

Phone: 71-5298096

Email: [email protected]

Menno HUISMAN, Pr

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jo RASKIN, Dr

Role: primary

Andrea PENALOZA, Pr

Role: primary

Alexandre GHUYSEN, Pr

Role: primary

Francis COUTURAUD, Pr

Role: primary

Jeannot SCHMIDT, Pr

Role: primary

Isabelle MAHE, Pr

Role: primary

Olivier SANCHEZ, Pr

Role: primary

Laurent BERTOLETTI, Dr

Role: primary

Giorgio COSTANTINO, Pr

Role: primary

Roberto POLA, Dr

Role: primary

Marije ten WOLDE, Dr

Role: primary

Michiel COPPENS, Dr

Role: primary

Marcel HOVENS, Dr

Role: primary

Marco GROOTENBOERS, Dr

Role: primary

Rolf BROUWER, Dr

Role: primary

Yordi VAN DOOREN

Role: primary

Pieter Willem KAMPHUISEN, Pr

Role: primary

Menno HUISMAN, Pr

Role: primary

Jenneke LEENTJENS, Dr

Role: primary

Reinier Albert SPRENGER

Role: primary

Mariëlle DE VREEDE

Role: primary

Martje MAAS

Role: primary

René VAN DER GRIEND, Dr

Role: primary

David Jiménez, Pr

Role: primary

Tobias TRITSCHLER, Dr

Role: primary

Marc RIGHINI, Pr

Role: primary

Olivier HUGLI, Dr

Role: primary

Other Identifiers

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HYDRA (29BRC20.0087)

Identifier Type: -

Identifier Source: org_study_id