Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
NCT ID: NCT02464592
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2014-04-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Biopsy with Cryoprobes
Transbronchial lung biopsy with a cryoprobe.
Transbronchial lung biopsy.
Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Biopsy with Conventional Forceps
Transbronchial lung biopsy with conventional forceps.
Transbronchial lung biopsy.
Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Interventions
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Transbronchial lung biopsy.
Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Eligibility Criteria
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Inclusion Criteria
* Patients with diffuse lung disease candidate to study with transbronchial lung biopsy (TBLB).
* Inform consent signed.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Hospital Universitario La Fe
OTHER
Germans Trias i Pujol Hospital
OTHER
Hospital General Universitario Santa Lucía
OTHER
Hospital Universitari de Bellvitge
OTHER
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Complejo Hospitalario Universitario de Vigo
OTHER
University of Salamanca
OTHER
Hospital Universitario de Valladolid
UNKNOWN
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Virginia Pajares, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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References
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Pajares V, Puzo C, Castillo D, Lerma E, Montero MA, Ramos-Barbon D, Amor-Carro O, Gil de Bernabe A, Franquet T, Plaza V, Hetzel J, Sanchis J, Torrego A. Diagnostic yield of transbronchial cryobiopsy in interstitial lung disease: a randomized trial. Respirology. 2014 Aug;19(6):900-6. doi: 10.1111/resp.12322. Epub 2014 Jun 1.
Pajares V, Nunez-Delgado M, Bonet G, Perez-Pallares J, Martinez R, Cubero N, Zabala T, Cordovilla R, Flandes J, Disdier C, Torrego A; MULTICRIO Group researchers. Transbronchial biopsy results according to diffuse interstitial lung disease classification. Cryobiopsy versus forceps: MULTICRIO study. PLoS One. 2020 Sep 21;15(9):e0239114. doi: 10.1371/journal.pone.0239114. eCollection 2020.
Other Identifiers
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IIBSP-CRI-2014-05
Identifier Type: -
Identifier Source: org_study_id