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

Completed

• Conditions: Malignant Pleural Effusion

• Registration Number: NCT02625675
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-03-19
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-09
• Primary Completion: 2017-07-06
• Study Completion: 2017-07-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinico-radiological confirmation of pleurodesis success post pleurodesis.	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

Name	Time	Method
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.

Trial Locations

Locations (1)

Oxford Respiratory Trials Unit, Churchill Hospital; 🇬🇧 Oxford, United Kingdom