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Pleural Ultrasonography in Lung Cancer - PULC


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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.


Inclusion Criteria:



- Lung lesion being evaluated for surgery during initial consultation with a thoracic
surgeon

Exclusion Criteria:

- Age < 18 years old

- Inability to consent for the study

- Chest wall anatomy precluding PULC

- Inability to sit upright

- Medications including Warfarin (Coumadin) or Clopidogrel (Plavix) in patient
requiring pleural fluid aspiration

- Active cutaneous infection overlying proposed puncture site

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Moishe Liberman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier de l'Université de Montréal

Authority:

Canada: Ethics Review Committee

Study ID:

CE 10.046

NCT ID:

NCT01141946

Start Date:

June 2010

Completion Date:

October 2010

Related Keywords:

  • Lung Cancer
  • lung cancer
  • pleural effusion
  • post-op care
  • diaphragmatic ultrasound
  • Lung Neoplasms

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