Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation.

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.

Conditions

• Lung Transplant Rejection

Interventions

PROCEDURE

Biopsies CP

Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.

PROCEDURE

Biopsies FC

Transbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Javier De Gracia, Pneumologist · Respiratory department

• Karina I Loor, MD · Respiratory department

• Mario Culebras, MD · Respiratory department

• Antonio Álvarez, MD · Respiratory department

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-15

Primary Completion

2018-01-31

Completion

2018-03-31

Countries

• Spain

Study Locations