NCT05792384

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	transbronchial lung biopsy with biopsy forceps	Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps

Timeline

• Start date: 2023-04-06
• Primary completion: 2024-12-24
• Completion: 2024-12-31
• First posted: 2023-03-31
• Last updated: 2023-03-31