Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

NCT ID: NCT05792384

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2024-12-31

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.

Conditions

Lung Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

transbronchial cryobiopsy

transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe

Group Type: EXPERIMENTAL

transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

Intervention Type: PROCEDURE

Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

transbronchial lung biopsy

transbronchial lung biopsy with biopsy forceps

Group Type: ACTIVE_COMPARATOR

transbronchial lung biopsy with biopsy forceps

Intervention Type: PROCEDURE

Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps

Interventions

transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

Intervention Type: PROCEDURE

transbronchial lung biopsy with biopsy forceps

Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ting YANG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Yang, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Central Contacts

Run Tong, MD

Role: CONTACT

tong-run@hotmail.com

010-84205729

Other Identifiers

2021-I2M-1-049-03-TBCB

Identifier Type: -

Identifier Source: org_study_id