Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

Lung Transplant Rejection Clinical Trial

Official title:

Research on Comprehensive Management of End-stage Severe Chronic Respiratory Diseases - Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05792384
• Other study ID #: 2021-I2M-1-049-03-TBCB
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: China-Japan Friendship Hospital
• Contact: Run Tong, MD
• Phone: 010-84205729
• Email: tong-run[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant Rejection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of complications	Incidence of complications	one day, 3 days and 7 days after lung biopsy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	number of attempts to get five samples	number of attempts to get five samples	during surgery