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

NCT02625675 | Completed

• 1 other identifier: TUS Pleurodesis
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• 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.

Interventions

Ultrasound scan OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford Respiratory Trials Unit, Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

• Corcoran JP, Hallifax RJ, Mercer RM, Yousuf A, Asciak R, Hassan M, Piotrowska HE, Psallidas I, Rahman NM. Thoracic Ultrasound as an Early Predictor of Pleurodesis Success in Malignant Pleural Effusion. Chest. 2018 Nov;154(5):1115-1120. doi: 10.1016/j.chest.2018.08.1031. Epub 2018 Sep 20.

  PMID: 30243566 DERIVED

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: December 9, 2015
• Study Start: March 19, 2015
• Primary Completion: July 6, 2017
• Study Completion: July 6, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

GB (1)