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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Transplant Rejection
• Intervention / Treatment: Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe; Procedure: transbronchial lung biopsy with biopsy forceps

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Run Tong, MD; Phone Number: 010-84205729; Email: tong-run@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transbronchial cryobiopsy; transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe	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
Active Comparator: transbronchial lung biopsy; transbronchial lung biopsy with biopsy forceps	Procedure: transbronchial lung biopsy with biopsy forceps; Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung biopsy with biopsy forceps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection	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).	7 days after lung biopsy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Ting Yang, MD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 6, 2023
• Primary Completion (Anticipated): December 24, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-I2M-1-049-03-TBCB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No