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Using Thoracic Ultrasound to Predict Pleurodesis Success in Malignant Pleural Effusions: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02625675
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
The observational pilot study at the Churchill Hospital, funded by Oxford Respiratory Trials Unit, will assess the feasibility and efficacy of thoracic ultrasound (TUS) assessment in patients undergoing talc pleurodesis via intercostal chest drain (ICD) for recurrent symptomatic malignant pleural effusions (MPE). Participants will undergo TUS pre and post pleurodesis on up to four occasions. We hypothesise that a TUS scoring system will be able to predict short and long-term pleurodesis success earlier than current conventional medical practice allows. This study may ultimately allow the proposal of a treatment algorithm to manage patients with MPE in a more efficient manner.

Condition or disease Intervention/treatment
Malignant Pleural Effusion Other: Ultrasound scan

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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Thoracic Ultrasound to Predict Pleurodesis Success in Malignant Pleural Effusions: a Pilot Study
Actual Study Start Date : March 19, 2015
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. Clinico-radiological confirmation of pleurodesis success post pleurodesis. [ Time Frame: 1 month ]
    Pleurodesis success confirmed as no radiographic and/or ultrasonographic evidence of significant pleural fluid recurrence; and/or no clinical need for further pleural intervention for symptomatic relief.

  2. Clinico-radiological confirmation of pleurodesis success post pleurodesis. [ Time Frame: 3 months ]
    Pleurodesis success confirmed as no radiographic and/or ultrasonographic evidence of significant pleural fluid recurrence; and/or no clinical need for further pleural intervention for symptomatic relief.


Secondary Outcome Measures :
  1. Difference (in days) between hypothetical discharge date based on thoracic ultrasound findings and actual discharge date based on standard clinical care. [ Time Frame: Through study completion, an average of 3 months. ]
  2. Patient satisfaction with thoracic ultrasound as measured using a Likert-type scale [ Time Frame: Through study completion, an average of 3 months. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults undergoing drainage of a malignant pleural effusion and subsequent talc pleurodesis via an intercostal chest drain as part of their routine planned care.
Criteria

Inclusion Criteria:

  • The participant is willing and able to give informed consent for participation in the study.
  • Adult male or female, aged 18 years or above.
  • Diagnosed with a malignant pleural effusion requiring intercostal chest drain insertion and subsequent talc slurry pleurodesis for symptom relief and/or other therapeutic purposes as part of routine clinical care.

Exclusion Criteria:

  • Age less than 18 years.
  • Inability to provide informed consent
  • Known hypersensitivity/allergy to medical talc, or other contraindication to the administration of intrapleural talc, as determined by the responsible clinician.
  • Evidence of significant trapped lung that would prevent pleurodesis being performed, as determined by the clinician responsible for assessing the patient.
  • Expected survival of less than one month due to underlying co-morbidities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625675


Locations
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United Kingdom
Oxford Respiratory Trials Unit, Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02625675     History of Changes
Other Study ID Numbers: TUS Pleurodesis
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms