Diagnostic Value of Transbronchial Lung Cryobiopsy

May 23, 2018 updated by: Yserbyt Jonas, KU Leuven

Feasibility, Safety and Diagnostic Value of Transbronchial Lung Cryobiopsy in the Work-up of Diffuse Interstitial Lung Diseases.

Evaluating the diagnostic value of transbronchial lung cryobiopsy (TBLC) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (DILD) who are referred for invasive histopathological diagnostics

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Before one is able to state that TBLC is a technique that is an alternative for VATS biopsy, the diagnostic value of TBLC should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. For this purpose direct comparison between VATS biopsy and TBLC is unavoidable. By including TBLC in the work-up of patients with DILD in which histopathological assessment is indicated (as proposed by MDD), we want to assess 3 major points of concern.

Agreement for the histopathological diagnosis between VATS biopsy and TBLC. Value of TBLC in the specific diagnosis in ILD.

Study Type

Observational

Enrollment (Anticipated)

20

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

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

interstitial lung disease, fibrotic or non-fibrotic

Description

Inclusion Criteria:

  • - Case of DILD presented at the MDD
  • Referral for VATS biopsy as advised by MDD.
  • Informed consent available
  • Age > 18
  • FVC > 50%pred
  • DLCO > 40%pred
  • PaO2 > 65 mmHg, pCO2 < 45 mmHg
  • No exclusion criteria

Exclusion Criteria:

  • - Age > 75
  • PAPS >40mmHg as measured on transthoracic cardiac ultrasound
  • Platelet count <100000/µl
  • INR > 1.4
  • BMI >30
  • Diffuse bullous lung disease
  • Active anti-platelet or anticoagulant treatment
  • Active heart failure or unstable coronary heart disease
  • Patients unfit for VATS under general anaesthesia as assessed by the surgeon and/or anesthesiologist

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histopathological agreement
Time Frame: 2 years
Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedural safety : bleeding
Time Frame: periprocedural 1 hour
incidence of bleeding (number of case)
periprocedural 1 hour
procedural safety : bleeding (2)
Time Frame: periprocedural 1 hour
severity of bleeding (grade 1-2-3)
periprocedural 1 hour
procedural safety : bleeding (3)
Time Frame: periprocedural 1 hour
duration of bleeding (seconds)
periprocedural 1 hour
procedural safety : penumothorax
Time Frame: periprocedural 1 hour
pneumothorax rate (number of cases)
periprocedural 1 hour

Collaborators and Investigators

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

Sponsor

KU Leuven

Investigators

  • Principal Investigator: jonas Yserbyt, Universitaire Ziekenhuizen KU Leuven

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 (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZLPNE1015

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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