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Search / Trial NCT05754866

Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure

Launched by CHINA-JAPAN FRIENDSHIP HOSPITAL · Mar 3, 2023

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called transbronchial lung cryobiopsy (TBLC) to help doctors understand the cause of acute respiratory failure in patients who haven't received a clear diagnosis after initial tests. Acute respiratory failure is a serious condition where the lungs can't provide enough oxygen to the body. The trial aims to see if TBLC can improve the chances of getting a correct diagnosis compared to another method called transbronchial lung biopsy (TBLB), with the hope that having a clearer diagnosis will lead to better treatment outcomes for patients.

To be eligible for the trial, participants should be experiencing acute hypoxemic respiratory failure—this means their oxygen levels are dangerously low—and their doctors haven't been able to determine the cause through standard tests. Patients must also have specific imaging results that show unusual patterns in their lungs. However, certain conditions, like severe heart problems or bleeding issues, will prevent someone from joining the study. If a patient participates, they can expect to undergo the TBLC procedure, which involves using a special tool to take a small sample of lung tissue for testing. Families of participants will need to give their consent for the patient to be part of the trial. This study is currently recruiting participants aged 65 and older, and it welcomes all genders.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosis of acute hypoxemic respiratory failure
  • 2. Routine assessments \[including bronchoscopy, bronchoalveolar lavage fluid cytology and pathogenic (including pathogenic mNGS) tests, blood tests, etc.\] do not clarify the etiology, or there is an unexplained disease process
  • 3. Imaging shows a multi-lobar segmental distribution of ground glass opacity with or without consolidations
  • 4. Patients' families agreed to participate in the study and signed an informed consent form
  • Exclusion Criteria:
  • 1. Significant hemodynamic instability
  • 2. Uncorrectable coagulopathy
  • 3. Severe pulmonary hypertension
  • 4. Acute coronary syndrome
  • 5. Intermediate-high-risk acute pulmonary embolism
  • 6. Acute phase of stroke
  • 7. Severe emphysema
  • 8. Aortic dissection and massive gastrointestinal bleeding
  • 9. Other conditions that are not suitable for participation in the clinical trial

About China Japan Friendship Hospital

China-Japan Friendship Hospital is a leading clinical research institution dedicated to advancing healthcare through innovative medical research and trials. Established as a collaborative effort between China and Japan, the hospital integrates cutting-edge technology with traditional medical practices, fostering a multidisciplinary approach to patient care and clinical studies. The institution is committed to enhancing therapeutic outcomes and improving patient safety while adhering to rigorous ethical standards. With a diverse team of experienced healthcare professionals and researchers, China-Japan Friendship Hospital plays a pivotal role in addressing global health challenges and contributing to medical knowledge through its extensive clinical trial programs.

Locations

Beijing, , China

Nanchang, , China

Suzhou, , China

Zhengzhou, , China

Changsha, , China

Wuhan, , China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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