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Manometry vs Clinical Assessment in the Detection of Trapped Lung in Patients With Suspected Pleural Malignancy (MASCOT)

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ClinicalTrials.gov Identifier: NCT02805062
Recruitment Status : Unknown
Verified June 2016 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
First Posted : June 17, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Rocket Medical plc
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
Malignant pleural effusion is a common clinical problem with median survival of approximately 6 months thus efficient management of Malignant pleural effusion is important. In patients with a Trapped Lung, pleurodesis will be unsuccessful and an indwelling pleural catheter should be inserted instead. Accurate detection of Trapped Lung prior to insertion would avoid futile attempts at talc pleurodesis, re-intervention following failed pleurodesis and allow adequate time to plan for an indwelling pleural catheter insertion.Pleural manometry allows direct and objective measurement of intra-pleural pressure during pleural fluid aspiration.The primary aim of this study is to determine whether the addition of digital pleural manometry to clinical judgment, prior to and during local anaesthetic thoracoscopy, results in a clinically meaningful improvement in Trapped Lung detection.

Condition or disease Intervention/treatment
Pleural Effusion, Malignant Procedure: Digital Pleural Manometry Procedure: Magnetic Resonance Imaging

Detailed Description:

Malignant pleural effusion is a common clinical problem with median survival of approximately 6 months. Efficient management of Malignant pleural effusion is therefore a major priority for patients, for whom failed procedures and the need for repeat hospital admissions limits their time at home with family and friends.

The management of Malignant pleural effusion involves either complete pleural fluid drainage followed by some form of pleurodesis or insertion of an indwelling pleural catheter. Apposition of the parietal and visceral pleural surfaces is a pre-requisite for successful pleurodesis. In patients with a non-expansile, or Trapped Lung, pleurodesis will be unsuccessful and an indwelling pleural catheter should be inserted instead. Accurate detection of Trapped Lung prior to insertion would avoid futile attempts at talc pleurodesis, re-intervention following failed pleurodesis and allow adequate time to plan for an indwelling pleural catheter insertion, including training of the patient's District Nurses. Clinical judgment is currently used to detect Trapped Lung. This involves review of available imaging and direct visualisation of the surface of the lung during local anaesthetic thoracoscopy. Unfortunately, recent data suggest this is frequently inaccurate, with 30% and 13% of cases of Trapped Lung correctly identified in recent local and national audit data respectively.

Pleural manometry allows direct and objective measurement of intra-pleural pressure during pleural fluid aspiration. Pleural pressure measurements can also be used to compute Pleural Elastance, defined as change in pleural pressure divided by change in pleural volume. Previous studies have shown that a rapid and sustained drop in intra-pleural pressure during fluid aspiration can predict Trapped Lung but these data have not been prospectively compared with current clinical practice.

The primary aim of this study is to determine whether the addition of digital pleural manometry to clinical judgment, prior to and during local anaesthetic thoracoscopy, results in a clinically meaningful improvement in Trapped Lung detection. Digital pleural manometry will be recorded using a Conformité Européene marked (CE-marked) device used within its existing clinical indication (developed in conjunction with our commercial partner Rocket Medical plc).

65 Subjects will have a single study visit, which will coincide with their planned clinical admission for local anaesthetic thoracoscopy. Subjects will exit the study after a follow-up clinic visit 3 months after the date of local anaesthetic thoracoscopy. A study-specific volumetric Magnetic Resonance Imaging scan of the pleural cavity will be performed as per pre-defined imaging protocols.

The study will be performed at a single centre: Queen Elizabeth University Hospital, Glasgow.


Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Manometry vs Clinical Assessment in the Detection of Trapped Lung in Patients With Suspected Pleural Malignancy
Study Start Date : June 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2017

Group/Cohort Intervention/treatment
Pleural Effusion
Malignant pleural effusion patients requiring investigation with thoracoscopy.
Procedure: Digital Pleural Manometry
Measurement of intra-pleural pressure and the removal of pleural fluid.

Procedure: Magnetic Resonance Imaging
Subject lies a long tunnel shaped scanner and images are recorded.
Other Name: MRI




Primary Outcome Measures :
  1. Pleural Elastance [ Time Frame: Single visit per subject ]
    Pleural elastance (change in pleural pressure divided by change in pleural volume), where trapped lung will be predicted by pleural elastance ≥ 14.5 cm pleural pressure.

  2. Clinical judgement [ Time Frame: Single visit per subject ]
    The clinical judgment of the Thoracoscopist as to the presence or absence of Trapped Lung

  3. Trapped Lung [ Time Frame: Single visit per subject ]
    Occurrence of trapped lung, defined as incomplete lung re-expansion on the pre-discharge chest radiograph after local anaesthetic thoracoscopy


Secondary Outcome Measures :
  1. PEL-VOUT Agreement [ Time Frame: Single visit per subject ]
    level of agreement between Indirect Pleural Elastance (PEL) computed using pleural fluid output (VOUT) and Direct PEL, computing using directly measured pleural cavity volume by MRI.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pleural effusion requiring further investigation with thoracoscopy.
Criteria

Inclusion Criteria:

  • Informed written consent
  • Suspected pleural malignancy requiring investigation by local anaesthetic thoracoscopy

Exclusion Criteria:

  • Any contra-indication to local anaesthetic thoracoscopy
  • Predicted pleural aspiration volume < 1 litre, as defined by a maximum pleural fluid depth of < 4 cm on thoracic ultrasound pre-aspiration
  • Known contra-indication to MRI
  • Previous attempt at talc pleurodesis
  • Pregnancy
  • • Renal impairment (eGFR ≤ 30 ml/min)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805062


Contacts
Contact: Paul Dearie, BSc (HONS) +44 (0)141 232 1810 paul.dearie@ggc.scot.nhs.uk

Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Rocket Medical plc

Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02805062     History of Changes
Other Study ID Numbers: GN16ON124
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Published results will not personally identify study subjects.

Keywords provided by NHS Greater Glasgow and Clyde:
Trapped Lung

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms