Pleural Effusion
Conditions
Keywords
thoracoscopy, pleuroscopy, metastatic cancer, lung cancer, malignant pleural effusion, tuberculosis
Brief summary
Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study. One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy to the following groups: Group A (mini-thoracoscopy) Group B (Conventional rigid thoracoscopy) Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions
Detailed description
A significant proportion of patients with pleural effusions remain undiagnosed after performance of diagnostic procedures including cytological and microbiologic analysis of the pleural fluid and closed pleural biopsies. In this study, the investigators plan to compare the yield and safety of mini-thoracoscopy and conventional rigid thoracoscopy with the larger diameter scope. This is a prospective study that will be conducted at the Thoracic Endoscopy Suite of the Department of Pulmonary Medicine, PGIMER, Chandigarh. Consecutive patients who are planned to undergo a medical thoracoscopy for obtaining pleural biopsies will be enrolled in the study One hundred subjects will be randomized in 1:1 ratio to undergo thoracoscopy. The randomization sequence will be generated using a computer (in blocks of 10), and the allocation will be placed in opaque sealed envelopes. The patients will be randomized to the following groups: Group A (mini-thoracoscopy): The mini-thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used. It has an outer diameter of 5.5 mm and a working channel diameter of 3.5 mm. Group B (Conventional rigid thoracoscopy): The rigid thoracoscope manufactured by Richard Wolf GmbH, Knettligen, Germany will be used that has an outer diameter of 10 mm and channel internal diameter of 5 mm. Primary outcome: (a) diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions.
Interventions
DEVICEMini-thoracoscopy
Thoracoscopic pleural biopsy with the mini-thoracoscope
DEVICEConventional rigid thoraoscopy
Thoracoscopic pleural biopsy with the conventional rigid thoraoscope
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Medical thoracoscopy being performed for obtaining a pleural biopsy
Exclusion criteria
* PaO2/FIO2\< 300; Hemodynamic instability Myocardial infarction or unstable angina in the last 6 wk Lack of pleural space due to adhesions Uncorrected coagulopathy Failure to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity (intention-to-treat) | 6 months | Difference between the diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracoscopic biopsy in the two groups out of the total diseased |
| Diagnostic sensitivity (per protocol) | 6 months | Diagnostic sensitivity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true positives diagnosed by thoracocopic biopsy. In this analysis, the subjects crossed over to the rigid group (due to failure of minirigid to yield biopsy tissue) will be considered in the rigid group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic specificity | 6 months | Difference between the diagnostic specificity of mini-thoracoscopy and conventional rigid thoracoscopy in the diagnosis of exudative pleural effusions by calculating the number of true negatives diagnosed by thoracoscopic biopsy in the two groups out of those not diseased |
| Adverse effects | 1 month | Differences between number of participants with treatment-related adverse events as assessed by CTCAE v4.0 in the two groups |
| Scope maneuverability | 1 day | Differences between maneuverability of the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator |
| Sedative and analgesic dose | 1 day | Comparing doses of sedative and analgesic agents required in the two groups |
| Incision size | 1 day | Difference in the size of the incision required with the use of the two devices |
| Procedure duration | 1 day | Difference in the duration of procedure in the two groups |
| Pain scores by Wong Baker FACES pain rating scale | 1 day | Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the Wong Baker FACES pain rating scale) in the two groups |
| Ease of obtaining biopsy | 1 day | Differences between ease of obtaining pleural biopsy with the two thoracoscopes on a visual analog scale (0-100 mm) assessed by the operator |
| Pain scores by visual analog scale | 1 day | Difference between intraoperative pain score associated with the use of the two devices (assessed after the procedure using the visual analog scale from 0-no pain to 100-maximum possible pain) in the two groups |
Countries
India
Contacts
Primary ContactSahajal Dhooria, MD, DM
Backup ContactRitesh Agarwal, MD, DM
Outcome results
None listed