Transbronchial Cryobiopsy in Lung Transplant Patients
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|ClinicalTrials.gov Identifier: NCT03090594|
Recruitment Status : Unknown
Verified March 2017 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was: Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Cryobiopsy has displaced the transbronchial biopsy (BTB) with forceps because it allows to obtain samples of more representative pulmonary parenchyma with more alveoli, less artifacts and a greater diagnostic yield. However, some authors report an increase in adverse effects such as hemorrhage and pneumothorax. The latest ISHLT (International Society for Heart and Lung Transplantation) consensus of 2007 recommends that with BTB with forceps a minimum of five tissue samples should be obtained that should contain more than 100 wells or the presence of two bronchioles to Which may be necessary between 3 and 17 samples. The optimal number of transbronchial cryobiopsies is unknown in order to obtain maximum performance with the lowest possible morbidity.
It is proposed to analyze the morphological and histopathological characteristics of each cryobiopsies individually and in order of extraction, to determine the sensitivity in the diagnosis of acute rejection as a function of the number of samples. Lung transplant patients, not admitted to critical units, with BTB indication will be included. A maximum of 6 samples will be obtained by flexible bronchoscope and under general anesthesia.
These data will allow to know the minimum number of specimens that guarantee a histological and / or bacteriological diagnosis of certainty with maximum effectiveness.
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplantation||Procedure: Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Performance and Complications of Transbronchial Cryobiopsy in Lung Transplant Patients According to the Number of Samples Obtained|
|Actual Study Start Date :||March 14, 2017|
|Estimated Primary Completion Date :||September 17, 2017|
|Estimated Study Completion Date :||March 2018|
Transbronchial biopsies with cryoprobe.
Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.
- Number of transbronchial biopsies with which a pathological diagnosis is obtained. The rejection graduation according to the criteria of the International Society for Heart Lung Transplantation (ISHLT). [ Time Frame: 5-7 days. ]A maximum of 6 samples will be obtained.
- Number of alveoli, bronchi, bronchioles, blood vessels and pleura containing each biopsy. [ Time Frame: 30 days. ]The Mese Software will be used. ¨Leica Application Suite X¨.
- Number of complications related to the procedure. [ Time Frame: 30 days. ]Complications related to the procedure: bleeding, pneumothorax, pneumonia, acute respiratory failure or need for hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090594
|Contact: Karina Loor, MD||93 274 firstname.lastname@example.org|
|Contact: Javier De Gracia, MD PhD||93 274 email@example.com|
|Hospital Vall de Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Contact: Karina Loor, MD 93 274 6138 firstname.lastname@example.org|
|Contact: Javier De Gracia, MD 93 274 6138 email@example.com|
|Sub-Investigator: Karina Loor, MD|
|Sub-Investigator: Mario Culebras, MD|
|Sub-Investigator: Antonio Álvarez, MD|
|Principal Investigator:||Javier De Gracia, MD PhD||Respiratory department.|
|Study Chair:||Karina Loor, MD||Respiratory department.|
|Study Chair:||Mario Culebras, MD||Respiratory department.|
|Study Chair:||Antonio Álvarez, MD||Respiratory department.|