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A pilot study to assess feasibility, safety and efficacy of artificially introducing an air-pleura interface for detection of pleural nodules by computed tomography

Feasibility, safety and efficacy of using artificial pneumothorax to detect pleural abnormalities by computed tomography - A pilot study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000337572
Enrollment
20
Registered
2015-04-14
Start date
2018-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will evaluate the use of an artificial air-pleura interface by introducing air into the chest for a computed tomography (CT) scan to detect abnormalities in patients with known or suspected malignant pleural effusion. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have known or suspected malignant pleural effusion and have a chest drain in-situ. Study details: All participants will have two CT scans: one standard CT scan and one CT scan with an artificial air-pleura interface. The artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. The findings on pleura detected by the two CT scans will be compared. No previous studies have specifically assessed pleural abnormalities through this technique. We hypothesize for this study that artificially creating an air-pleura interface will make the small pleural nodules (~1cm) more conspicuous and will allow significantly better detection of previously undetectable pleural abnormalities/ nodules by CT scan.

Interventions

Patients with suspected or proven MPE undergoing a standard CT scan examination as part of routine clinical management will be included in this study. Immediately after the first standard CT scan an artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. A second CT scan will be performed immediately afterwar

Patients with suspected or proven MPE undergoing a standard CT scan examination as part of routine clinical management will be included in this study. Immediately after the first standard CT scan an artificial air-pleura interface will be created by introducing 500mL of air via an in-situ chest drain [such as intercostal catheter (ICC) or indwelling pleural catheter (IPC)]. The air is introduced using a syringe connected to the chest drain. A second CT scan will be performed immediately afterwards. The abnormal findings on pleura detected by the two CT scans will be compared. The approximate duration for the procedure and scan will be approximately 15 minutes.

Sponsors

Prof YC Gary Lee
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient with known or suspected malignant pleural effusion, 1.1. Who as part of his/her standard clinical care, a) has a previously inserted chest drain in-situ, and b) requires a standard CT scan. 1.2. Does not have evidence of advanced, pleural malignancy or abnormalities on their previous CT scan. 2. Will be able to undergo CT scan procedure. 3. Is able to comply with the protocol. 4. Is able to give written informed consent.

Exclusion criteria

1. Age < 18 years. 2. Respiratory distress or oxygen saturation less than 92% on room air or FEV1 less than 50% on spirometry. 3. Patients unable to tolerate CT scanning (unable to lie supine or prone, renal failure, claustrophobia, contrast allergy). 4. Patients who are pregnant or lactating.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026