NCT02579304

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
3.2 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

3.9 years

First QC Date

October 12, 2015

Last Update Submit

May 23, 2018

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • histopathological agreement

    Histopathological diagnostic intra-observer agreement between Video-assisted thoracosopic surgery biopsy and TBLC (kappa value)

    2 years

Secondary Outcomes (4)

  • procedural safety : bleeding

    periprocedural 1 hour

  • procedural safety : bleeding (2)

    periprocedural 1 hour

  • procedural safety : bleeding (3)

    periprocedural 1 hour

  • procedural safety : penumothorax

    periprocedural 1 hour

Interventions

transbronchial lung cryobiopsyPROCEDURE

bronchoscopic sampling

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

interstitial lung disease, fibrotic or non-fibrotic

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

transbronchial lung biopsies

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • jonas Yserbyt

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 19, 2015

Study Start

January 1, 2019

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

BE(1)