NCT03727568

Brief Summary

Interstitial lung diseases (ILD) are a heterogeneous collection of more than 100 different pulmonary disorders. Surgical lung biopsie in combination with multidisciplinary discussion is recommend in combination to reach a consensus diagnosis when the initial clinical evaluation is inconclusive in the diagnosis of ILD. Cryobiopsy via bronchoscopy is approved for lung biopsies and allows harvesting of large tissue samples of excellent. This technique is not jet standardized. In this prospective randomised study the investigators want to evaluate the diagnostic yield comparing two different techniques of performing transbronchial cryobiopsy. In this study would be compared a shorter freezing time and more number of biopsies vs a longer freezing time and less number of biopsies.

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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 11, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

3.7 years

First QC Date

October 22, 2018

Last Update Submit

October 31, 2022

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    The investigator will assess the proportion of patients in which a definitive diagnosis is possible after Multi-Disciplinary Discussion

    2 years

Secondary Outcomes (4)

  • Complications

    2 years

  • Number of diagnostic samples

    2 years

  • Correlation between the suspected clinical diagnosis and the histological diagnosis

    2 years

  • Correlation between between radiological pattern and final diagnosis

    2 years

Study Arms (2)

Cryobiopsy: longer freezing time

EXPERIMENTAL

Group nº1: A total of 3 samples with a freezing time of 7 seconds at least for the first biopsy and a freezing time from ≥5 seconds for the following biopsies.

Procedure: Cryobiopsy

Cryobiopsy: shorter freezing time

EXPERIMENTAL

Group nº 2: A total of 8 samples with a freezing time of 3 seconds at least for the first biopsy and a freezing time from \<5 seconds for the following biopsies.

Procedure: Cryobiopsy

Interventions

CryobiopsyPROCEDURE

In this study the investigators want to evaluate the diagnostic yield comparing 2 different techniques of performing cryobiopsy. A shorter freezing time and more number of biopsies vs a longer freezing time and less number of biopsies would be compared. Patients are randomised to the groups 1 or 2 immediate before the bronchoscopy. Group 1: a total of 3 samples with a freezing time of 7 seconds at least for the first biopsy and freezing time for 5 seconds or more for the followings biopsies Group 2: a total of 8 samples with a freezing time of 3 seconds at least for the first biopsy and freezing time for less than 5 seconds for the followings biopsies

Cryobiopsy: longer freezing timeCryobiopsy: shorter freezing time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients with suspected ILD based on clinical and radiological features
  • Male or female patients aged ≥18 years
  • Signed the informed consent
  • Clinical indication to performed a lung biopsy in radiologically proven ILD

You may not qualify if:

  • Bleeding risk:
  • Known predisposition to bleeding
  • International randomised ratio (INR) \>1,5,
  • Elevated partial thromboplastin time (PTT)
  • Platelet count \< 80000/ul
  • Patients who required full-dose therapeutic anticoagulation or clopidogrel or other thienopyridines
  • Oxygen saturation \< 90% with supported Oxygen 2l/min
  • Severe bullous pulmonary emphysema
  • Severe cardiac disease (angina pectoris, acute myocardial infarction in the last 6 month, acute hearth failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhrlandklinik

Essen, North Rhine-Westphalia, 45239, Germany

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Kaid Darwiche

    Head of department of inteventionel pneumology, Ruhrlandklinik Essen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med Kaid Darwiche, Head Department of Interventional Pneumology

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 1, 2018

Study Start

September 11, 2018

Primary Completion

May 11, 2022

Study Completion

December 31, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations

DE(1)