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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: University of Oxford

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
  • Patient satisfaction with thoracic ultrasound as measured using a Likert-type scale [ Time Frame: Through study completion, an average of 3 months. ]


Original Secondary Outcome: Same as current

Information By: University of Oxford

Dates:
Date Received: October 21, 2015
Date Started: March 2015
Date Completion:
Last Updated: June 23, 2016
Last Verified: June 2016