Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique

NCT01472172 | Completed Early Phase 1 DMC

• 1 other identifier: Endo-0002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion; Pleural Diseases

Keywords

Flex-rigid pleuroscopy; cryobiopsy; pleural biopsy; pleural effusion; safety; thoracoscopy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Bleeding

  1 month

Study Arms (1)

Cryobiopsy

EXPERIMENTAL

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)

Interventions

Cryobiopsy (Autoclavable cryoprobe 20416-032) 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.

Also known as: Autoclavable cryoprobe 20416-032 (ERBE, Germany)

Cryobiopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled bleeding tendency
• Unstable cardiovascular status
• Severe heart failure
• ECOG performance status 4
• Persistent hypoxemia after evacuation of pleural fluid
• Pleural symphisis, fibrothorax

Sponsors & Collaborators

• The University Clinic of Pulmonary and Allergic Diseases Golnik: lead

Study Sites (1)

University Clinic Golnik

Golnik, Golnik, 4204, Slovenia

Location

MeSH Terms

Conditions

Pleural Effusion; Pleural Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Ales Rozman, MD

  University Clinic Golnik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of endoscopy department

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: February 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

SL (1)