Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

Not Applicable

Completed

• Conditions: Pleural Effusion; Tuberculosis; Pleurisy; Metastatic Malignancy
• Interventions: Device: Cryoprobe pleural biopsy first; Device: Flexible forceps biopsy first

• Registration Number: NCT02500277
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cryobiopsy	Cryoprobe pleural biopsy first	Pleural biopsy with a flexible cryoprobe
Forceps biopsy	Flexible forceps biopsy first	Pleural biopsy with a flexible forceps

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration of procedure	One day	Time taken for the procedure with the two techniques
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
Biopsy size	One day	Size of biopsy specimens obtained with the two techniques
Ease of biopsy VAS	One day	Ease of taking biopsy with the two techniques assessed using a visual analog scale
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"
Tissue depth	One day	Depth of the tissue obtained on histopathology

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, India