Pleural Ultrasonography in Lung Cancer (CT0018)

Pleural Ultrasonography in Lung Cancer - PULC

Lung cancer remains the leading cause of mortality from malignant diseases in both men and women worldwide. Accurate diagnosis, staging and therapeutic targeting of lung cancer and other pulmonary pathology are vital with regards to providing patients with expedient and accurate treatment and treatment plans. The pre-operative evaluation and consultation in patients who are to undergo operative staging or resection for lung cancer is multidimensional and involves detailed history taking, physical examination and review of imaging studies. Two important elements of both staging and pre-operative evaluation include the evaluation of: (1) the pleural space for malignant pleural effusion and (2) the diaphragm for appropriate movement. At this point in time, the pleural space evaluation is being performed using CT scan which does not allow the acquisition of real-time cytological material from pleural effusions due to the fact that the CT scans are done in a diagnostic setting. Diaphragmatic movement/excursion is not currently being assessed pre-operatively and its impact on staging and post-operative pulmonary function is unknown.

Malignant pleural effusion is recognized as a poor prognosticator in non-small cell lung cancer patients and has recently been upgraded from a T4 to an M1a status in the new edition of the AJCC NSCLC Staging System (7th Edition). The appreciation of the poor prognosis related to malignant effusion has upgraded the stage from a Stage IIIb to a stage IV. Recognizing the stage early allows for more precise prognostication of disease and can lead to precision and streamlining of treatment plans for thoracic surgeons and oncologists.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: thoracic ultrasound; Procedure: pleural aspiration

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.	3 months

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Fonds de la Recherche en Santé du Québec; Centre de Recherche du Centre Hospitalier de l'Université de Montréal; Society of University Surgeons

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: lung cancer; pleural effusion; post-op care; diaphragmatic ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CE 10.046