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Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy (COFFEE)

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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

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

Condition or disease Intervention/treatment Phase
Pleural Effusion Pleurisy Tuberculosis Metastatic Malignancy Device: Cryoprobe pleural biopsy first Device: Flexible forceps biopsy first Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study
Study Start Date : January 2015
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: Cryobiopsy
Pleural biopsy with a flexible cryoprobe
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).

Active Comparator: Forceps biopsy
Pleural biopsy with a flexible forceps
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Biopsy size [ Time Frame: One day ]
    Size of biopsy specimens obtained with the two techniques

  2. Duration of procedure [ Time Frame: One day ]
    Time taken for the procedure with the two techniques

  3. Ease of biopsy VAS [ Time Frame: One day ]
    Ease of taking biopsy with the two techniques assessed using a visual analog scale

  4. 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

  5. Tissue depth [ Time Frame: One day ]
    Depth of the tissue obtained on histopathology

  6. 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"



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Ages Eligible for Study:   12 Years to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500277


Locations
India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Responsible Party: Sahajal Dhooria, Assistant Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02500277     History of Changes
Other Study ID Numbers: NK/1815/Res/2439
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Sahajal Dhooria, Postgraduate Institute of Medical Education and Research:
thoracoscopy
pleuroscopy
semirigid thoracoscopy
flexible cryoprobe
cryobiopsy
pleural biopsy

Additional relevant MeSH terms:
Tuberculosis
Pleural Effusion
Pleurisy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Infections