Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation

NCT05792384 | Unknown

• 1 other identifier: 2021-I2M-1-049-03-TBCB
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of complications

  one day, 3 days and 7 days after lung biopsy

• Sample size

  during surgery

• the number of alveoli in the biopsy sample

  7 days after lung biopsy

• the number of blood vessels in the biopsy sample

  7 days after lung biopsy

• the percentage of the area of lung parenchyma without artifacts in the biopsy sample

  7 days after lung biopsy

Study Arms (2)

transbronchial cryobiopsy

EXPERIMENTAL

transbronchial cryobiopsy with a 1.1 mm flexible cryoprobe

Procedure: transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

transbronchial lung biopsy

ACTIVE COMPARATOR

transbronchial lung biopsy with biopsy forceps

Procedure: transbronchial lung biopsy with biopsy forceps

Interventions

transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe PROCEDURE

Obtaining lung biopsy samples of patients after lung transplantation through transbronchial lung cryobiopsy with a 1.1 mm flexible cryoprobe

transbronchial cryobiopsy

transbronchial lung biopsy with biopsy forceps PROCEDURE

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

transbronchial lung biopsy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Officials

• Ting Yang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Run Tong, MD

CONTACT

010-84205729; tong-run@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 31, 2023
• Study Start: April 6, 2023
• Primary Completion: December 24, 2024
• Study Completion: December 31, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03