Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy (COFFEE)

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Pleurisy; Tuberculosis; Pleural Effusion; Metastatic Malignancy

Treatments: Device: Cryoprobe pleural biopsy first; Device: Flexible forceps biopsy first

Study type: Interventional

Funder types: Other

Identifiers

NCT02500277

NK/1815/Res/2439

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 12 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Cryobiopsy

Active Comparator group

Description:

Pleural biopsy with a flexible cryoprobe

Treatment:

Device: Cryoprobe pleural biopsy first

Forceps biopsy

Active Comparator group

Description:

Pleural biopsy with a flexible forceps

Treatment:

Device: Flexible forceps biopsy first