Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

Post Graduate Institute of Medical Education and Research, Chandigarh50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Pleural Effusion Pleurisy Tuberculosis Metastatic Malignancy

Interventions

Cryoprobe pleural biopsy firstDEVICE

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).

Flexible forceps biopsy firstDEVICE

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)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

PGIMER

Chandigarh, India

Outcomes

Primary Outcomes

Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

Time frame: One week

Secondary Outcomes

Biopsy size

Size of biopsy specimens obtained with the two techniques

Time frame: One day

Duration of procedure

Time taken for the procedure with the two techniques

Time frame: One day

Ease of biopsy VAS

Ease of taking biopsy with the two techniques assessed using a visual analog scale

Time frame: One day

Artifacts

Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe

Time frame: One day

Tissue depth

Depth of the tissue obtained on histopathology

Time frame: One day

Bleeding

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"

Time frame: One day

Data from ClinicalTrials.gov

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