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Transbronchial Cryobiopsy in Lung Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

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

Detailed Description:
Transbronchial biopsies (BPTB) will be performed using a flexible bronchoscope and the biopsy will be performed with cryoprobe (Erbokryo®). The patient undergoing the procedure will be intubated, sedated and relaxed under continuous monitoring (pulse oximetry, blood pressure, heart and respiratory rate), oxygen therapy with high flows and surveillance by anesthesiologist. The site where the biopsies will be performed will be determined based on an imaging study (chest x-ray and / or CT scan). The procedure will be performed according to the conventional technique, keeping the patient in apnea during the time that the cryobiopsies are taken to reduce the risk of pneumothorax. At most 6 samples will be obtained, and each one will be placed in an individual container listed in order of extraction. Bronchoalveolar lavage (3 aliquots of 30 mL sterile saline solution) will be performed in the same hemithorax. The samples obtained will be evaluated morphologically and sent to a microbiological and histopathological study, which will include a cell count. The data obtained will be coded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Transbronchial biopsies with cryoprobe.
Procedure: Biopsy
Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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¨.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pulmonary transplant patients with suspected rejection or infection requiring transbronchial biopsy

Exclusion Criteria:

  • Respiratory failure refractory to oxygen therapy.
  • Acute or subacute ischemic heart disease (last 4-6 weeks).
  • Severe arrhythmias.
  • Coagulation disorders: platelets <60,000-50,000 or Prothrombin time <60%.
  • Lack of consent informed.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03090594

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Contact: Karina Loor, MD 93 274 6138
Contact: Javier De Gracia, MD PhD 93 274 6138

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Hospital Vall de Hebron Recruiting
Barcelona, Spain, 08035
Contact: Karina Loor, MD    93 274 6138   
Contact: Javier De Gracia, MD    93 274 6138   
Sub-Investigator: Karina Loor, MD         
Sub-Investigator: Mario Culebras, MD         
Sub-Investigator: Antonio Álvarez, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
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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.

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute Identifier: NCT03090594     History of Changes
Other Study ID Numbers: CB JKMT-2
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Acute cellular rejection