Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

Tuberculosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500277
• Other study ID #: NK/1815/Res/2439
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Malignancy
• Pleural Effusion
• Pleurisy
• Tuberculosis

Intervention

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).
• 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)

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One week
Secondary	Biopsy size	Size of biopsy specimens obtained with the two techniques	One day
Secondary	Duration of procedure	Time taken for the procedure with the two techniques	One day
Secondary	Ease of biopsy VAS	Ease of taking biopsy with the two techniques assessed using a visual analog scale	One day
Secondary	Artifacts	Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe	One day
Secondary	Tissue depth	Depth of the tissue obtained on histopathology	One day
Secondary	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"	One day