The goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (TBCB) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of TBCB for monitoring after lung transplantation, It is expected to provide a better auxiliary examination method for lung transplantation. The main questions it aims to answer are: (1) Histopathological evaluability of specimens; (2) Safety of TBCB; (3) Size and quality of specimen, and number of attempts to obtain five samples. Participants will undergo TBCB with 1.1 mm flexible cryoprobe or traditional transbronchial lung biopsy with biopsy forceps.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe
Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection
Diagnostic yield of transbronchial cryobiopsy (TBCB) for diagnosing the lung transplantation rejection, compare with that of traditional transbronchial lung biopsy. The reference standard is the result of Multi-Disciplinary Treatment (MDT).
Time frame: 7 days after lung biopsy
Incidence of complications
Incidence of complications
Time frame: one day, 3 days and 7 days after lung biopsy
Sample size
The area size of the biopsy sample will be measured using the software Image J (version 1.48; Maryland, MD, USA) , and measured in square millimetres.
Time frame: during surgery
the number of alveoli in the biopsy sample
The number of alveoli in the biopsy sample is recorded, according to the histological analysis of the biopsy paraffin section.
Time frame: 7 days after lung biopsy
the number of blood vessels in the biopsy sample
The number of blood vessels in the biopsy sample is recorded, according to the histological analysis of the biopsy paraffin section.
Time frame: 7 days after lung biopsy
the percentage of the area of lung parenchyma without artifacts in the biopsy sample
The percentage of the area of lung parenchyma without artifacts in the biopsy sample is measured (by the software Image J) and recorded, according to the histological analysis of the biopsy paraffin section.
Time frame: 7 days after lung biopsy
number of attempts to get five samples
number of attempts to get five samples
Time frame: during surgery
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