Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study

NCT01475084 | Completed Phase 2 DMC

• 1 other identifier: Endo-0003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pleural Effusion; Pleural Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety

  1 month

Study Arms (1)

Cryobiopsy, forceps biopsy

EXPERIMENTAL

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.

Device: cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps

Interventions

cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps 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. Forceps biopsy will be performed on usual way.

Also known as: Autoclavable cryoprobe 20416-032 (ERBE, Germany), Flexible FB-55CD-1 Olympus forceps

Cryobiopsy, forceps biopsy

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: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

SL (1)