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

May 2, 2015 updated by: Boeckeler, Michael, University Hospital Tuebingen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany
        • University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical indications for biopsy of interstitial lung disease
  2. Age over 18 years
  3. Signed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: transbronchial forceps lung biopsy
transbronchial lung biopsy forceps
Procedure: transbronchial lung biopsy
ACTIVE_COMPARATOR: transbronchail cryo lung biopsy
transbronchial lungbiopsy with cryoprobe
Procedure: transbronchial lung biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic value of each biopsy procedure. It will be identified, how often biopsy contributed to the final diagnosis.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in the final diagnosis
Time Frame: 24 Months
24 Months

Other Outcome Measures

Outcome Measure
Time Frame
Bleeding None, Mild degree (suction <= 3min), Moderate (extraction> 3min), Severe (intervention: tamponade, surgery)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Jürgen Hetzel, MD, University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (ESTIMATE)

July 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 2, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBB2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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