Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

The purpose of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.

Study Overview

• Status: Completed
• Conditions: Pleural Diseases; Pleural Effusion
• Intervention / Treatment: Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)

Detailed Description

The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Slovenia
  • Golnik
    • Golnik 36, Golnik, Slovenia, 4204
      • University Clinic Golnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cryobiopsy; Biopsies 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. The biopsy sample will by extracted by gently pulling of the probe.

Device: Cryobiopsy (Autoclavable cryoprobe 20416-032); 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.; Other Names: Autoclavable cryoprobe 20416-032 (ERBE, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe	To determine, wheather cryobiopsy specimen can be obtained in each patient	12 months
Size of biopsy samples	Size of the biopsy specimens in mm2	12 months
Quality of the sample	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 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding	Number of patients with a certain degree of bleeding from biopsy site, described 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

Collaborators and Investigators

• Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Investigators: Principal Investigator: Ales Rozman, MD, University Clinic Golnik

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: safety; pleural effusion; thoracoscopy; Flex-rigid pleuroscopy; pleural biopsy; cryobiopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Effusion; Pleural Diseases
• Other Study ID Numbers: Endo-0002