Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Lung Transplant Rejection

Treatments: Procedure: transbronchial lung biopsy with biopsy forceps; Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

Study type: Interventional

Funder types: Other

Identifiers

NCT05792384

2021-I2M-1-049-03-TBCB

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

transbronchial cryobiopsy

Experimental group

Description:

transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe

Treatment:

Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

transbronchial lung biopsy

Active Comparator group

Description:

transbronchial lung biopsy with biopsy forceps

Treatment:

Procedure: transbronchial lung biopsy with biopsy forceps