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

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.

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion, Malignant
• Intervention / Treatment: 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
• Enrollment (Anticipated): 65

Contacts and Locations

Participation Criteria

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

Patients with pleural effusion requiring further investigation with thoracoscopy.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pleural Elastance	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.	Single visit per subject
Clinical judgement	The clinical judgment of the Thoracoscopist as to the presence or absence of Trapped Lung	Single visit per subject
Trapped Lung	Occurrence of trapped lung, defined as incomplete lung re-expansion on the pre-discharge chest radiograph after local anaesthetic thoracoscopy	Single visit per subject

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEL-VOUT Agreement	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.	Single visit per subject

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Rocket Medical plc

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2016
• Last Update Submitted That Met QC Criteria: June 20, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Trapped Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion
• Other Study ID Numbers: GN16ON124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Published results will not personally identify study subjects.