Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

October 26, 2018 updated by: Wissenschaftliches Institut Bethanien e.V

Cryobiopsy vs. VATS: Efficiency and Safety in the Diagnosis of Interstitial Lung Diseases

The purpose of this study is to assess efficiency and safety of cryobiopsy compared to video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases (ILD). To that end, this non-interventional study prospectively collects data from patients undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to VATS if this procedure is reasonable. The information gained by this study will help to assess the significance of cryobiopsy in contrast to VATS in this particular disease group.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

62

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
    • NRW
      • Solingen, NRW, Germany, 42699
        • Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine

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

Sampling Method

Probability Sample

Study Population

Inpatients undergoing routine diagnosis of known or suspected interstitial lung disease

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Known or newly diagnosed interstitial lung disease (ILD)
  • Indication for lung biopsy for definitive ILD diagnosis
  • Informed Consent provided

Exclusion Criteria:

  • Age < 18 years
  • Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease
  • Severely restricted CO diffusion capacity (<50%)
  • Pregnancy, lactation
  • Any medical, psychological or other condition restricting the patient's ability to provide informed consent
  • Participation in another clinical trial

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

Cohorts and Interventions

Group / Cohort
ILD diagnosis
Patients subjected to Cryobiopsy and/or VATS for diagnosis of interstitial lung disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of diagnostic cryobiopsies
Time Frame: up to 3 days
For the individual study participant, the result of the cryobiopsy (whether it is diagnostically helpful, i.e. "diagnostic" or not, i.e. "inconclusive") will be documented when it is available, which will be within 3 days. The overall number of diagnostic cryobiopsies will be calculated once the study is complete.
up to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications during cryobiopsy
Time Frame: During and up to 48 hours after procedure
Number of complications associated with cryobiopsy, divided into three categories of severity: mild/moderate/severe
During and up to 48 hours after procedure
Rate of complications during VATS
Time Frame: During and up to 10 days after procedure
Number of complications associated with VATS, divided into three categories of severity: mild/moderate/severe
During and up to 10 days after procedure

Collaborators and Investigators

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

Sponsor

Wissenschaftliches Institut Bethanien e.V

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 (Actual)

October 16, 2012

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI_KryoVATS_80/2012

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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