Pleural Ultrasonography in Lung Cancer

NCT01141946 | Completed

• 1 other identifier: CE 10.046
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

lung cancer; pleural effusion; post-op care; diaphragmatic ultrasound

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• The ability of pre-operative diaphragmatic ultrasound to predict post-operative morbidity following pulmonary surgery.

  3 months

Interventions

thoracic ultrasound PROCEDURE

All patients will receive pre-operative pleural-based ultrasound during their initial consultation.

pleural aspiration PROCEDURE

Before proceeding to pleural aspiration, a radiography of the chest will be performed in order to ascertain the presence of a pleural effusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Pleural Effusion

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Moishe Liberman, MD, PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 11, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 17, 2012

Record last verified: 2011-06

Locations

CA (1)