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

Malignant Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625675
• Other study ID #: TUS Pleurodesis
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: January 8, 2018
• Start date: March 19, 2015
• Est. completion date: July 6, 2017

Study information

• Verified date: January 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 6, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Other:
• Ultrasound scan

Locations

Country	Name	City	State
United Kingdom	Oxford Respiratory Trials Unit, Churchill Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinico-radiological confirmation of pleurodesis success post pleurodesis.	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
Primary	Clinico-radiological confirmation of pleurodesis success post pleurodesis.	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	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.
Secondary	Patient satisfaction with thoracic ultrasound as measured using a Likert-type scale		Through study completion, an average of 3 months.