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Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation.

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ClinicalTrials.gov Identifier: NCT03090581
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 29, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
The survival of lung transplant patients (PD) is limited mainly by Infections, graft dysfunction in the immediate postoperative period and chronic dysfunction. Up to 36% have an episode of acute rejection after transplantation. For the diagnosis of these pathologies, transbronchial lung biopsy (BPTB) is essential. The classical method is the realization of BPTB with conventional clamp, but the performance diagnosis is limited. However, the use of cryoprobes for sampling in other pulmonary pathologies have been shown to achieve a higher diagnostic yield. The BPTB performance is variable and depends on factors such as sample size and the presence of artifacts (crushing) produced by the forceps tweezers. The objective principal is to compare the diagnostic yield of samples obtained with cryoprobe compared to those obtained with conventional biopsy tweezers. A prospective, randomized, and comparative study is proposed for all patients in the intensive care unit after lung transplantation in a 24-month period, at Vall de Hebron Hospital. Patients will be divided into two groups: symptomatic and asymptomatic. The exclusion criteria are the contraindications of the procedure and the factors which increase the hemorrhagic risk. A flexible bronchoscope (BF-18BS) will be used and the procedure will be performed according to the technique conventional. The patient undergoing the procedure will be intubated, sedated and relaxed under supervision and continuous monitoring by an intensivist. A bronchoalveolar lavage and a maximum of 6 samples will be obtained. Morphological study (middle area, artifacts, components, diagnosis), microbiological, histological and anatomopathological according to the usual protocol. The duration of the procedure, the complications and the frequency with which the diagnosis obtained after the procedure modifies the therapeutic behavior will be monitored. These data will allow to evaluate the potential benefits of this procedure in the diagnosis of pulmonary pathology in lung transplantation.

Condition or disease Intervention/treatment Phase
Lung Transplant Rejection Procedure: Biopsies CP Procedure: Biopsies FC Not Applicable

Detailed Description:
Bronchoscopic examinations will be performed with intubated patients under continuous monitoring (pulse oximetry, blood pressure, heart and respiratory rate), Oxygen therapy with high flows and surveillance by anesthesiologist. The bronchopulmonary lobe where the biopsies will be performed is determined prior to the procedure based on an imaging study (chest x-ray or computed tomography). Transbronchial biopsies will be obtained using a flexible bronchoscope (Pentax, 3.2 mm working channel), which approaches the subsegment where the affected area is located. The 2.4 mm diameter cryoprobe is placed (Erbokryo®), and moves forward until it encounters a soft resistance. The cryoprobe is removed between 5-10 mm and the freezing is applied for 3 seconds. After 3 seconds, the probe is gently removed together with the bronchoscope and frozen tissue sample at the tip of the probe. In the case of strong resistance, the process is stopped and then repeated. In the case of the use of forceps, the conventional technique is used.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: A prospective, randomized, comparative study in all patients.
Primary Purpose: Diagnostic
Official Title: Prospective Study of Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation Admitted to an Intensive Care Unit.
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Biopsies CP 1
Obtain transbronchial lung biopsies with cryoprobe (CP) 1
Procedure: Biopsies CP
Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.

Active Comparator: Biopsies CP 2
Obtain transbronchial lung biopsies with cryoprobe (CP) 2
Procedure: Biopsies CP
Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.

Active Comparator: Biopsies FC
Obtain transbronchial lung biopsies with forceps (FC).
Procedure: Biopsies FC
Transbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps.




Primary Outcome Measures :
  1. Number of patients in whom a pathological diagnosis is obtained after obtaining transbronchial biopsies, performed with forceps or cryosondes. [ Time Frame: 5 days after biopsies ]
    Graft rejection is classified according to the criteria of the International Society for Heart and Lung Transplantation (ISHLT) in 2007.


Secondary Outcome Measures :
  1. Number of alveoli, bronchioles, bronchi, blood vessels and pleura containing each biopsy. [ Time Frame: 5 days after biopsies ]
    A microscope will be used with Software Mese. ¨Leica Application Suite X¨.

  2. Number of complications related to the procedure. [ Time Frame: 30 days after biopsies ]
    Complications: bleeding, pneumothorax, infection or acute respiratory failure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pulmonary transplant patients admitted to the intensive care unit who are assigned a transbronchial lung biopsy.

Exclusion Criteria:

  • Respiratory insufficiency refractory to oxygen therapy.
  • Acute or subacute ischemic heart disease.
  • Severe arrhythmias.
  • Coagulation disorders: platelets < 60,000-50,000 or Prothrombin time > 60%.
  • Lack of informed consent.

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 ClinicalTrials.gov identifier (NCT number): NCT03090581


Contacts
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Contact: Karina I Loor, MD 93 274 6138 ext 6496 kloor@vhebron.net
Contact: Javier De Gracia, MD PhD 93 274 6138 ext 6496 jgracia.jgracia@gmail.com

Locations
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Spain
Hospital Vall de Hebron. Recruiting
Barcelona, Catalonia, Spain, 08035
Contact: Karina I Loor, MD    932746138    kloor@vhebron.net   
Contact: Javier De Gracia, MD PhD    932746138    jgracia.jgracia@gmail.com   
Sub-Investigator: Karina I Loor, MD         
Sub-Investigator: Mario Culebras, MD         
Sub-Investigator: Antonio Álvarez, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Javier De Gracia, Pneumologist Respiratory department
Study Chair: Karina I 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
ClinicalTrials.gov Identifier: NCT03090581     History of Changes
Other Study ID Numbers: CB JKMT-1
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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:
Graft Rejection/diagnosis
Lung Transplantation
Cryoprobe