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Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy (COFFEE)

Primary Purpose

Pleural Effusion, Pleurisy, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cryoprobe pleural biopsy first
Flexible forceps biopsy first
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Effusion focused on measuring thoracoscopy, pleuroscopy, semirigid thoracoscopy, flexible cryoprobe, cryobiopsy, pleural biopsy

Eligibility Criteria

12 Years - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cryobiopsy

Forceps biopsy

Arm Description

Pleural biopsy with a flexible cryoprobe

Pleural biopsy with a flexible forceps

Outcomes

Primary Outcome Measures

Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

Secondary Outcome Measures

Biopsy size
Size of biopsy specimens obtained with the two techniques
Duration of procedure
Time taken for the procedure with the two techniques
Ease of biopsy VAS
Ease of taking biopsy with the two techniques assessed using a visual analog scale
Artifacts
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
Depth of the tissue obtained on histopathology
Bleeding
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"

Full Information

First Posted
July 13, 2015
Last Updated
August 29, 2018
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02500277
Brief Title
Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy
Acronym
COFFEE
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 Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Pleurisy, Tuberculosis, Metastatic Malignancy
Keywords
thoracoscopy, pleuroscopy, semirigid thoracoscopy, flexible cryoprobe, cryobiopsy, pleural biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryobiopsy
Arm Type
Active Comparator
Arm Description
Pleural biopsy with a flexible cryoprobe
Arm Title
Forceps biopsy
Arm Type
Active Comparator
Arm Description
Pleural biopsy with a flexible forceps
Intervention Type
Device
Intervention Name(s)
Cryoprobe pleural biopsy first
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Flexible forceps biopsy first
Intervention Description
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 Measure Information:
Title
Yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy
Description
The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy
Time Frame
One week
Secondary Outcome Measure Information:
Title
Biopsy size
Description
Size of biopsy specimens obtained with the two techniques
Time Frame
One day
Title
Duration of procedure
Description
Time taken for the procedure with the two techniques
Time Frame
One day
Title
Ease of biopsy VAS
Description
Ease of taking biopsy with the two techniques assessed using a visual analog scale
Time Frame
One day
Title
Artifacts
Description
Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe
Time Frame
One day
Title
Tissue depth
Description
Depth of the tissue obtained on histopathology
Time Frame
One day
Title
Bleeding
Description
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"
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

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