Metastatic Malignancy, Pleural Effusion, Pleurisy, Tuberculosis
Conditions
Keywords
thoracoscopy, pleuroscopy, semirigid thoracoscopy, flexible cryoprobe, cryobiopsy, pleural biopsy
Brief summary
This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
Detailed description
Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups: Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.
Interventions
DEVICECryoprobe pleural biopsy first
Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).
DEVICEFlexible forceps biopsy first
Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥12 years * Semirigid thoracoscopy being performed for diagnosis of the pleural effusion
Exclusion criteria
* Age ≥80 years * SpO2 \<88% on room air * 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 |
|---|---|---|
| Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy | One week | The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of procedure | One day | Time taken for the procedure with the two techniques |
| Ease of biopsy VAS | One day | Ease of taking biopsy with the two techniques assessed using a visual analog scale |
| Biopsy size | One day | Size of biopsy specimens obtained with the two techniques |
| Tissue depth | One day | Depth of the tissue obtained on histopathology |
| Bleeding | One day | Number of participants with bleeding seen while taking biopsy categorised into no bleeding, minimal self limited ooze, bleeding requiring prolonged suctioning , major hemorrhage requiring blood transfusion, causing hemodynamic instability or ICU admission |
| Artifacts | One day | Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe |
Countries
India
Outcome results
None listed