Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases

NCT03727568 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-11-02

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Cryobiopsy

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

Sponsors & Collaborators

  • Marta Cuyás

    collaborator UNKNOWN
  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Kaid Darwiche · Head of department of inteventionel pneumology, Ruhrlandklinik Essen

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2022-05-11
Completion
2022-12-31

Countries

  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03727568 on ClinicalTrials.gov