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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transbronchial cryobiopsy | Experimental | transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe |
|
| transbronchial lung biopsy | Active Comparator | transbronchial lung biopsy with biopsy forceps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe | Procedure | Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 days after lung biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | Incidence of complications | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Run Tong, MD | Contact | 010-84205729 | tong-run@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ting Yang, MD | China-Japan Friendship Hospital | Principal Investigator |
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| transbronchial lung biopsy with biopsy forceps | Procedure | Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps |
|
| 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. | 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. | 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. | 7 days after lung biopsy |
| number of attempts to get five samples | number of attempts to get five samples | during surgery |