Pleural Ultrasonography in Lung Cancer - PULC
Hypotheses:
1. Pleural ultrasonography with evaluation, quantification and aspiration of pleural
effusion allows for improved pre-operative staging and alters decision-making patterns
for lung cancer patients.
2. Pleural ultrasonography with evaluation of appropriate diaphragmatic respiratory
movement can predict post-operative complications in patient undergoing lung cancer
surgery.
Objectives:
The goals of this project within the program are to:
1. Evaluate the improvement in pre-operative staging with the addition of pre-operative
pleural ultrasonography for malignant pleural effusion.
2. Evaluate the ability of pre-operative diaphragmatic ultrasound to predict
post-operative morbidity following pulmonary surgery.
Methodology:
This study will consist of a prospective evaluation of surgeon-performed pleural and
diaphragmatic ultrasound in the pre-operative evaluation of lung cancer patients. All
patients being seen in the thoracic surgery pre-operative clinic with the new or presumed
diagnosis of lung cancer will be approached for prospective enrolment into the study.
Consented patients will undergo standard history and physical examination by the treating
thoracic surgeon. During or after the physical examination, PULC will be performed by the
study investigators.
Measurements will include: (1) bilateral diaphragmatic excursion during sniffing, (2)
pleural fluid evaluation in bilateral costophrenic sulci. Should pleural fluid be found on
the ipsilateral side to the mass (tumor), the fluid will be aspirated under sterile
conditions in the clinic and sent for cytology analysis. US evaluation will be performed in
the upright, supine and decubitus position.
Results will be analyzed using parametric methodology in order to ascertain the additional
information gained and the change in staging (upstaging) with the addition of PULC to
standard history and physical examination during the initial evaluation of thoracic surgical
patients.
The study will enrol 50 patients. Recruitment will occur at the thoracic outpatient surgical
clinic at the CHUM. Enrolment is expected at a level of five patients per week and therefore
the study recruitment is expected to take 2.5 months.
Impact:
The potential impact of a positive trial will change the way clinicians evaluate, stage and
risk stratify patients who are to undergo operative interventions for lung cancer.
Observational
Observational Model: Cohort, Time Perspective: Prospective
The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.
3 months
No
Moishe Liberman, MD, PhD
Principal Investigator
Centre Hospitalier de l'Université de Montréal
Canada: Ethics Review Committee
CE 10.046
NCT01141946
June 2010
October 2010
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