Skip to main content
Clinical Trials/NCT02625675
NCT02625675
Completed
Not Applicable

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

University of Oxford1 site in 1 country18 target enrollmentMarch 19, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Pleural Effusion
Sponsor
University of Oxford
Enrollment
18
Locations
1
Primary Endpoint
Clinico-radiological confirmation of pleurodesis success post pleurodesis.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 19, 2015
End Date
July 6, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Difference (in days) between hypothetical discharge date based on thoracic ultrasound findings and actual discharge date based on standard clinical care.(Through study completion, an average of 3 months.)
  • Patient satisfaction with thoracic ultrasound as measured using a Likert-type scale(Through study completion, an average of 3 months.)

Study Sites (1)

Loading locations...

Similar Trials