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A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions

18 Years
Open (Enrolling)
Malignant Pleural Effusions

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Trial Information

A Prospective Study of Patient Centered Outcomes in the Management of Malignant Pleural Effusions

This study will compare various treatment strategies in the management of malignant pleural
effusions with respect to:

1. Primary endpoint: the successful palliation of symptomatic pleural effusions as
assessed by the London Chest Activity of Daily Living Scale (LCADLS)

2. Secondary endpoints:

i) impact of treatment on patient quality of life as assessed by the Functional
Assessment of Chronic Illness Therapy - Palliative patient (FACIT-PAL) questionnaire
ii) Assessment of patient satisfaction with treatment received via Functional
Assessment of Chronic Illness Therapy-Treatment Satisfaction (FACIT-TS) questionnaire
iii)Pleurodesis success rates assessed by 2 and 6-week effusion control rates on CXR
iv) Requirement of further hospitalizations or procedures for the treatment of
recurrent effusions v) Comparison of morbidity and mortality rates for differing
treatment approaches vi) comparison of cost in a Canadian health care setting for
differing treatment approaches

Inclusion Criteria:

- symptomatic pleural effusion

- history of malignant disease

- age greater that 18 years

- consent to participate in study

Exclusion Criteria:

- significant ipsilateral endobronchial disease

- prior ipsilateral, intra-pleural therapy, as defined by: prior chest tube placement
for effusion, prior attempt at chemical/surgical pleurodesis, prior surgical

- active pulmonary or pleural infection

- granulocytes < 1500/mm3, platelets < 50,000/mm3

- systemic chemotherapy within 2 weeks

- allergy to talc

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Gail Darling, MD, FRCS(C)

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Toronto


Canada: Health Canada

Study ID:




Start Date:

August 2004

Completion Date:

December 2013

Related Keywords:

  • Malignant Pleural Effusions
  • Pleural Effusion
  • Pleural Effusion, Malignant