Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

Not Applicable

Not yet recruiting

• Conditions: Lung Transplant Rejection
• Interventions: Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe; Procedure: transbronchial lung biopsy with biopsy forceps

• Registration Number: NCT05792384
• Lead Sponsor: China-Japan Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Study Start: 2023-04-06
• Primary Completion: 2024-12-24
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transbronchial cryobiopsy	transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe	transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe
transbronchial lung biopsy	transbronchial lung biopsy with biopsy forceps	transbronchial lung biopsy with biopsy forceps

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection	7 days after lung biopsy	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of complications	one day, 3 days and 7 days after lung biopsy	Incidence of complications
Sample size	during surgery	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.
the number of alveoli in the biopsy sample	7 days after lung biopsy	The number of alveoli in the biopsy sample is recorded, according to the histological analysis of the biopsy paraffin section.
number of attempts to get five samples	during surgery	number of attempts to get five samples
the number of blood vessels in the biopsy sample	7 days after lung biopsy	The number of blood vessels in the biopsy sample is recorded, according to the histological analysis of the biopsy paraffin section.
the percentage of the area of lung parenchyma without artifacts in the biopsy sample	7 days after lung biopsy	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.