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Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

NCT ID: NCT01472172

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pleural Effusion Pleural Diseases

Keywords

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Flex-rigid pleuroscopy cryobiopsy pleural biopsy pleural effusion safety thoracoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cryobiopsy (Autoclavable cryoprobe 20416-032)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Autoclavable cryoprobe 20416-032 (ERBE, Germany)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role lead

Responsible Party

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Aleš Rozman

Head of endoscopy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ales Rozman, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic Golnik

Locations

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University Clinic Golnik

Golnik, Golnik, Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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Endo-0002

Identifier Type: -

Identifier Source: org_study_id