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Completed

NCT Number: NCT02500277

Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

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

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Key information

Conditions

Pleural Effusion Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Metastatic Malignancy Mycobacterium Infections Neoplasms Pleural Diseases Pleurisy Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

12 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIMER

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoprobe pleural biopsy first

Device

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 first

Device

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 outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Acronym: COFFEE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 16, 2015
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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