Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

Pleural Effusion Clinical Trial

Official title:

Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475084
• Other study ID #: Endo-0003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 16, 2011
• Last updated: September 8, 2015
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.

Description:

The investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 or more years old

• unilateral pleural effusion of unknown origin

• pleural irregularities suspicious for pleural malignancy

• referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

• uncontrolled bleeding tendency

• unstable cardiovascular status

• severe heart failure

• ECOG performance status 4

• persistent hypoxemia after evacuation of pleural fluid

• pleural symphisis, fibrothorax

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pleural Diseases
• Pleural Effusion

Intervention

Device:
• cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps
The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline. Forceps biopsy will be performed on usual way.

Locations

Country	Name	City	State
Slovenia	University Clinic Golnik	Golnik 36	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of forceps biopsy and cryobiopsy samples	diagnostic yield; size of the biopsy specimens in mm2; interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible); assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles	12 month	No
Secondary	Safety	The degree of bleeding at the biopsy site will be assessed as 1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation.	1 month	Yes