Cryobiopsy or Forceps Biopsy During Sem… | Clinical Trial

Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Clinic Golnik

Golnik, 4204, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

Comparison of forceps biopsy and cryobiopsy samples

Time frame: 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 outcomes

Safety

Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 21, 2011
Registry last updated: Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed