Clinical Trial: Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study

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 Summary:

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.


Sponsor: Postgraduate Institute of Medical Education and Research

Current Primary Outcome: Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy [ Time Frame: One week ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Biopsy size [ Time Frame: One day ]
    Size of biopsy specimens obtained with the two techniques
  • Duration of procedure [ Time Frame: One day ]
    Time taken for the procedure with the two techniques
  • Ease of biopsy VAS [ Time Frame: One day ]
    Ease of taking biopsy with the two techniques assessed using a visual analog scale
  • Artifacts [ Time Frame: 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
  • Tissue depth [ Time Frame: One day ]
    Depth of the tissue obtained on histopathology
  • Bleeding [ Time Frame: 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"


Original Secondary Outcome: Same as current

Information By: Postgraduate Institute of Medical Education and Research

Dates:
Date Received: July 13, 2015
Date Started: January 2015
Date Completion: June 2017
Last Updated: January 16, 2017
Last Verified: January 2017