Interstitial Lung Disease (ILD). Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy in the Same Surgical Stage.

Interstitial Lung Disease (ILD). Comparative Study of the Diagnostic Yield of Surgical Lung Biopsy Versus Cryobiopsy.

Patrocinadores

Patrocinador principal: Hospital Clinic of Barcelona

Fuente Hospital Clinic of Barcelona
Resumen breve

In patients with interstitial lung disease (ILD) with inconsistent clinical and radiological features, establishing a reliable diagnosis of ILD requires a surgical lung biopsy

Transbronchial cryobiopsy is a minimally invasive, rapid, safe technique, and with histologic diagnostic yields, for ILD, typically exceeding 70 -80% .

The aim of this study is to compare and analyze the diagnostic yield, for ILD, and complications following SLB and TC

Methods. The investigators designed a descriptive, comparative and cross-sectional study in patients with ILD, in which SLB and CT will be performed in the same surgical stage, as diagnostic tests.

This study will be conducted from January 2018 to January 2019. Surgical lung biopsy and TC will be performed in the same surgical stage in all patients, under general anesthesia and mechanical ventilation. First TC will be performed by a pulmonologist, sequentially a thoracic surgeon will carry out a SLB.

The samples obtained will be analyzed by different pathologist to compare both techniques in terms of histologic features.

Diagnostic yield, postoperative complications, comorbidities and lenght of stay will be analyzed and compared following these procedures.

Estado general Unknown status
Fecha de inicio March 23, 2018
Fecha de Terminación December 31, 2018
Fecha de finalización primaria December 31, 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Quality of the tissue sample reported by the pathologist. for statistical analysis, 12 months after the first inclusion
Inscripción 40
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Lung biopsy

Descripción: Each patient will be brought to the operating room and will undergo cryobiopsy and surgical biopsy of the lung sequentially in the same surgical stage.

Etiqueta de grupo de brazo: Lung biopsy

Otro nombre: Cryobiopsy

Elegibilidad

Criterios:

Inclusion Criteria:

- Patients for suspected ILD eligible for lung biopsy reviewed during multidisciplinary approach.

- Subject provides informed consent.

- A negative pregnancy test in women of child-bearing potential.

- Subject is mentally capable of understanding study procedures.

- 18 years and older.

Exclusion Criteria:

- Study subject has any disease or condition that interferes with safe completion of the study including:

- Platelet count < 50,000 or Coagulopathy defined as an International Normalized Ratio (INR) > 1.5 on the day of procedure, as well as discontinuation of ticagrelor or clopidogrel within 5 days of procedure.

- Severely impaired lung function as determined with spirometry evidenced by a forced expiratory volume in 1 second (FEV1) < 0.8, or radiographically as diffuse bullous disease

- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians

- Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements

- Concurrent participation in another study involving investigational drugs or investigational medical devices

- Inability to read and understand the necessary study documents

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Contacto general

Apellido: Alejandra Libreros Niño, MD

Teléfono: +34628296229

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Hospital Clinic Alejandra Libreros Niño, M.D. +34628296229 [email protected]
Ubicacion Paises

Spain

Fecha de verificación

July 2018

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Hospital Clinic of Barcelona

Nombre completo del investigador: Alejandra Libreros Niño

Título del investigador: MD

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Lung biopsy

Tipo: Other

Descripción: Lung biopsy

Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Diagnostic

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov