Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

Phase 2

Completed

• Conditions: Pleural Effusion; Pleural Diseases
• Interventions: Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps

• Registration Number: NCT01475084
• Lead Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-21
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryobiopsy, forceps biopsy	cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps	Cryoiopsies will be obtained by flexible autoclavable cryoprobe 20416-032 (Erbokryo CA, ERBE, Germany) with 2.4 mm in diameter. The tip of the probe is cooled to -890C with nitrous oxide within seconds after footswitch activation. Forceps biopsies will be obtained by flexible FB-55CD-1 Olympus forceps.

Primary Outcome Measures

Name	Time	Method
Comparison of forceps biopsy and cryobiopsy samples	12 month	* 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

Secondary Outcome Measures

Name	Time	Method
Safety	1 month	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.

Trial Locations

Locations (1)

University Clinic Golnik; 🇸🇮 Golnik 36, Golnik, Slovenia