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Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation | Clinical Trials | Clareo Health

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Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

Research on Comprehensive Management of End-stage Severe Chronic Respiratory Diseases - Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

NCT05792384•China-Japan Friendship Hospital

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

April 6, 2023

Primary Completion Date

December 24, 2024

Completion Date

December 31, 2024

Last Updated

March 31, 2023

Enrollment

120

ESTIMATED participants

Conditions

Lung Transplant Rejection

Interventions

transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

PROCEDURE

transbronchial lung biopsy with biopsy forceps

PROCEDURE

Contacts

Run Tong, MD

CONTACT

010-84205729 tong-run@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

Inclusion Criteria

Exclusion Criteria

Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI

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