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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03090594
Other study ID # CB JKMT-2
Secondary ID
Status Recruiting
Phase N/A
First received March 14, 2017
Last updated March 20, 2017
Start date March 14, 2017
Est. completion date March 2018

Study information

Verified date March 2017
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Karina Loor, MD
Phone 93 274 6138
Email kloor@vhebron.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date March 2018
Est. primary completion date September 17, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biopsy
Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.

Locations

Country Name City State
Spain Hospital Vall de Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). A maximum of 6 samples will be obtained. 5-7 days.
Secondary Number of alveoli, bronchi, bronchioles, blood vessels and pleura containing each biopsy. The Mese Software will be used. ¨Leica Application Suite X¨. 30 days.
Secondary Number of complications related to the procedure. Complications related to the procedure: bleeding, pneumothorax, pneumonia, acute respiratory failure or need for hospitalization. 30 days.
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