Pleural Ultrasonography in Lung Cancer (CT0018)

This study has been completed.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Society of University Surgeons
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01141946
First received: June 7, 2010
Last updated: July 16, 2012
Last verified: June 2011
  Purpose

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.


Condition Intervention
Lung Cancer
Procedure: thoracic ultrasound
Procedure: pleural aspiration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pleural Ultrasonography in Lung Cancer - PULC

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • The improvement in pre-operative staging with the addition of pre-operative pleural ultrasonography for malignant pleural effusion. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: thoracic ultrasound
    All patients will receive pre-operative pleural-based ultrasound during their initial consultation.
    Procedure: pleural aspiration
    Before proceeding to pleural aspiration, a radiography of the chest will be performed in order to ascertain the presence of a pleural effusion.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141946

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Fonds de la Recherche en Santé du Québec
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Society of University Surgeons
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01141946     History of Changes
Other Study ID Numbers: CE 10.046
Study First Received: June 7, 2010
Last Updated: July 16, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
lung cancer
pleural effusion
post-op care
diaphragmatic ultrasound

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014