Skip to main content
OpenTrials
Completed

NCT Number: NCT02625675

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Pleural Effusion Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Respiratory Trials Unit, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound scan

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2015
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.