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Completed

NCT Number: NCT01894113

Prospective, Randomised Multicenter Study Comparing the Efficacy of Transbronchial Forceps Biopsy With Cryobiopsy to Diagnose Interstitial Lung Disease.

The use of cryoprobes improves the diagnostic yield in transbronchial biopsies compared to forceps biopsies to diagnose an interstitial lung disease

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Tuebingen

Tübingen, Germany

About this study

Endoscopic biopsy currently plays only a minor role for the diagnosis of interstitial lung disease. However, in some cases obtaining lung tissue is necessary to establish a final diagnosis. The current standard procedure is transbronchial forceps biopsy - if not sufficient: surgical lung biopsy. Transbronchial lung biopsy bears essential limitations however:

  • Small tissue sample
  • Limited evaluability of the material caused by forceps-induced crush artifacts

In cryobiopsy the cryoprobe´s tip is being cooled and thereby cools the surrounding tissue to approximately minus 89 degrees Celsius. Subsequently, the frozen probe is retracted with the frozen tissue being attached onto the frozen probe's tip. When applied in the central airways, cryobiopsy proved to deliver large specimens of good quality, which may exceed forceps biopsies in terms of diagnostic yield. Pilot studies on transbronchial cryobiopsy showed that same advantages as seen in the endobronchial use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical indications for biopsy of interstitial lung disease
  • Age over 18 years
  • Signed consent

Exclusion criteria

  • Risk of bleeding / ongoing anticoagulation
  • Oxygen saturation <90% - despite delivery of 2l oxygen / min
  • Underlying cardiac disease (unstable angina, myocardial infarction during the last month, congestive heart failure)
  • Pulmonary hypertension, PAP sys> 50mmHg

Treatment and study plan

transbronchial lung biopsy

Procedure

Primary outcomes

  1. Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.

    Time frame: 24 months

Secondary outcomes

  1. Differences in the final diagnosis

    Time frame: 24 Months

Other outcomes

  1. Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Prospective, Randomised Multicenter Study Comparing Transbronchial Forceps Biopsy With Cryobiopsy in Interstitial Lung Disease

Acronym: TRABIS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 9, 2013
Registry last updated
May 5, 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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