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| Name | Class |
|---|---|
| Hospital Universitario La Fe | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Hospital General Universitario Santa Lucía | OTHER |
| Hospital Universitari de Bellvitge |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy with Cryoprobes | Active Comparator | Transbronchial lung biopsy with a cryoprobe. |
|
| Biopsy with Conventional Forceps | Active Comparator | Transbronchial lung biopsy with conventional forceps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transbronchial lung biopsy. | Procedure | Transbronchial lung biopsy with cryoprobe and with conventional forceps. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield of transbronchial lung biopsy (TBLB) | Comparing those TBLB obtained by cryoprobes versus conventional forceps (number of diagnosis with each technique). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histological quality of samples as defined the presence of alveolar units in each sample. Composite measure. | The quality of samples are defined by the size, presence of artifacts and presence of alveolar units in each sample. | 24 months |
| Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by chest radiography. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Pajares, PhD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24890124 | Background | 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. | |
| 32956379 |
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| 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 |
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Chest radiography after TBLB. |
| 24 months |
| Safety related to the procedure of the TBLB obtained by cryoprobe compared with conventional forceps assessed by control of bleeding. | Control of bleeding during procedure. | 24 months |
| 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. |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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