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Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy (COFFEE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500277
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Sahajal Dhooria, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE July 13, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pleural Effusion
  • Pleurisy
  • Tuberculosis
  • Metastatic Malignancy
Intervention  ICMJE
  • Device: Cryoprobe 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).
  • Device: Flexible 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)
Study Arms  ICMJE
  • Active Comparator: Cryobiopsy
    Pleural biopsy with a flexible cryoprobe
    Intervention: Device: Cryoprobe pleural biopsy first
  • Active Comparator: Forceps biopsy
    Pleural biopsy with a flexible forceps
    Intervention: Device: Flexible forceps biopsy first
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500277
Other Study ID Numbers  ICMJE NK/1815/Res/2439
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sahajal Dhooria, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP