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Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02464592
Enrollment
120
Registered
2015-06-08
Start date
2014-04-30
Completion date
2017-08-31
Last updated
2017-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Interstitial

Keywords

Cryoprobes, Transbronchial lung biopsy, Cryobiopsy

Brief summary

The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung disease.

Interventions

PROCEDURETransbronchial lung biopsy.

Transbronchial lung biopsy with cryoprobe and with conventional forceps.

Sponsors

Hospital Universitario La Fe
CollaboratorOTHER
Germans Trias i Pujol Hospital
CollaboratorOTHER
Hospital General Universitario Santa Lucía
CollaboratorOTHER
Hospital Universitari de Bellvitge
CollaboratorOTHER
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
CollaboratorOTHER
Complejo Hospitalario Universitario de Vigo
CollaboratorOTHER
University of Salamanca
CollaboratorOTHER
Hospital Universitario de Valladolid
CollaboratorUNKNOWN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* \>18 years old * Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB). * Inform consent signed.

Exclusion criteria

* FEV1 \<40% of reference value. * Respiratory insufficiency (pO2 \<60 mmHg or pCO2 \>45 mmHg). * Use of anticoagulant therapy or presence of a coagulation (disorder abnormal platelets counts, international normalized ratio \> 1.5). * Bullous emphysema. * Pulmonary arterial hypertension. * Hypersensitivity to anaesthetic and sedative drugs (lidocaine, midazolam, propofol, remifentanyl). * Psychiatric illness. * Comorbidities that could increase the risk of the TBLB. * Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yield of transbronchial lung biopsy (TBLB)24 monthsComparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique).

Secondary

MeasureTime frameDescription
Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure.24 monthsThe quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample.
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography.24 monthsChest radiography after TBLB.
Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding.24 monthsControl of bleeding during procedure.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026