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

January 8, 2018 updated by: University of Oxford
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LE
        • Oxford Respiratory Trials Unit, Churchill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
Through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2015

Primary Completion (Actual)

July 6, 2017

Study Completion (Actual)

July 6, 2017

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUS Pleurodesis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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