Clinical trial NCT05792384: Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation
Official title: Research on Comprehensive Management of End-stage Severe Chronic Respiratory Diseases - Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplant Rejection
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age among 18-65 years old
* After unilateral or bilateral lung transplantation, patient with unexplained pulmonary function decline, acute/chronic clinical lung injury or new pulmonary infiltrates
* or patients requiring monitoring of rejection after lung transplantation
* The patient should undertake routine preoperative examinations for lung cryobiopsy, including routine blood test, coagulation function, electrocardiogram, and chest CT, and the patients have no contraindications to cryobiopsy

Exclusion Criteria:

* patients intolerable to undertake lung biopsy due to severe cardiopulmonary insufficiency or being weak
* The patient is allergic to lidocaine and midazolam
* The patient has recent active massive hemoptysis, or the proposed biopsy site has a high risk of bleeding, such as bronchial artery penetration or suspected renal cancer lung metastasis
* Unstable angina, congestive heart failure, severe bronchial asthma or multiple bullae
* Severe hypertension and arrhythmia, hemodynamic instability and severe respiratory failure (PaO2\<60mmHg after oxygen therapy or mechanical ventilation)
* The patient has coagulation disorder and unable to stop taking anticoagulants, antiplatelet drugs, aspirin or non-steroidal anti-inflammatory drugs before lung biopsy
* Suspected aortic aneurysm
* The patient does not agree to participate in this study
* Participating in other studies within three months and not withdrawing or ending
* The researchers think that the patient are not suitable for inclusion

Primary outcomes:
measure: Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection
timeFrame: 7 days after lung biopsy
Secondary outcomes:
measure: Incidence of complications
timeFrame: one day, 3 days and 7 days after lung biopsy
measure: Sample size
timeFrame: during surgery
measure: the number of alveoli in the biopsy sample
timeFrame: 7 days after lung biopsy
measure: the number of blood vessels in the biopsy sample
timeFrame: 7 days after lung biopsy
measure: the percentage of the area of lung parenchyma without artifacts in the biopsy sample
timeFrame: 7 days after lung biopsy
measure: number of attempts to get five samples
timeFrame: during surgery
Other outcomes:
Locations:
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: