Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Transbronchial Lung Biopsy Versus Transbronchial Lung Cryobiopsy in Critically Ill Patients With Undiagnosed Acute Hypoxemic Respiratory Failure: a Multicenter Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754866
• Other study ID #: CJFH-2022-KY-194
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: February 2024
• Source: China-Japan Friendship Hospital
• Contact: Qingyuan Zhan, M.D.
• Phone: +86-13911785957
• Email: drzhanqy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with acute hypoxemic respiratory failure whose diagnosis is not established after initial evaluation, obtaining a histopathological diagnosis may improve the patients' prognosis. In our previous retrospective-controlled study, transbronchial lung cryobiopsy (TBLC) can lead to an increased chance of establishing a diagnosis compared with transbronchial lung biopsy (TBLB), with an acceptable safety profile. Therefore, further prospective randomized controlled studies exploring whether TBLC leads to improved prognosis for such patients are warranted.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Procedure:
• Transbronchial lung cryobiopsy
Lung tissue was obtained by transbronchial lung cryobiopsy for subsequent pathology and clinical diagnosis.
• Transbronchial lung biopsy
Lung tissue was obtained by transbronchial lung biopsy for subsequent pathology and clinical diagnosis.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing
China	The Second Xiangya Hospital	Changsha
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	The First Affiliated Hospital of Soochow University	Suzhou
China	The Sixth Hospital of Wuhan	Wuhan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Chang CH, Ju JS, Li SH, Wang SC, Wang CW, Lee CS, Chung FT, Hu HC, Lin SM, Huang CC. Feasibility and Safety of Transbronchial Lung Cryobiopsy for Diagnosis of Acute Respiratory Failure with Mechanical Ventilation in Intensive Care Unit. Diagnostics (Basel). 2022 Nov 23;12(12):2917. doi: 10.3390/diagnostics12122917. — View Citation

Gerard L, Bidoul T, Castanares-Zapatero D, Wittebole X, Lacroix V, Froidure A, Hoton D, Laterre PF. Open Lung Biopsy in Nonresolving Acute Respiratory Distress Syndrome Commonly Identifies Corticosteroid-Sensitive Pathologies, Associated With Better Outcome. Crit Care Med. 2018 Jun;46(6):907-914. doi: 10.1097/CCM.0000000000003081. — View Citation

Lim SY, Suh GY, Choi JC, Koh WJ, Lim SY, Han J, Lee KS, Shim YM, Chung MP, Kim H, Kwon OJ. Usefulness of open lung biopsy in mechanically ventilated patients with undiagnosed diffuse pulmonary infiltrates: influence of comorbidities and organ dysfunction. Crit Care. 2007;11(4):R93. doi: 10.1186/cc6106. — View Citation

Papazian L, Doddoli C, Chetaille B, Gernez Y, Thirion X, Roch A, Donati Y, Bonnety M, Zandotti C, Thomas P. A contributive result of open-lung biopsy improves survival in acute respiratory distress syndrome patients. Crit Care Med. 2007 Mar;35(3):755-62. doi: 10.1097/01.CCM.0000257325.88144.30. — View Citation

Philipponnet C, Cassagnes L, Pereira B, Kemeny JL, Devouassoux-Shisheboran M, Lautrette A, Guerin C, Souweine B. Diagnostic yield and therapeutic impact of open lung biopsy in the critically ill patient. PLoS One. 2018 May 25;13(5):e0196795. doi: 10.1371/journal.pone.0196795. eCollection 2018. — View Citation

Wang S, Feng Y, Zhang Y, Tian Y, Gu S, Wu X, Feng Y, Zhao L, Liu M, Wang D, Li Y, Tian Z, Wang S, Huang X, Zhou G, Zhan Q. Transbronchial lung biopsy versus transbronchial lung cryobiopsy in critically ill patients with undiagnosed acute hypoxemic respiratory failure: a comparative study. BMC Pulm Med. 2022 May 4;22(1):177. doi: 10.1186/s12890-022-01966-4. — View Citation

Wang S, Zhou G, Feng Y, Zhang Y, Tian Y, Gu S, Wu X, Li M, Feng Y, Wang D, Li Y, Tian Z, Zhao L, Li M, Chen W, Huang X, Zhan Q. Feasibility of transbronchial lung cryobiopsy in patients with veno-venous extracorporeal membrane oxygenation support. ERJ Open Res. 2022 Dec 19;8(4):00383-2022. doi: 10.1183/23120541.00383-2022. eCollection 2022 Oct. — View Citation

Zhou G, Feng Y, Wang S, Zhang Y, Tian Y, Wu X, Zhao L, Wang D, Li Y, Tian Z, Zhan Q. Transbronchial lung cryobiopsy may be of value for nonresolving acute respiratory distress syndrome: case series and systematic literature review. BMC Pulm Med. 2020 Jun 29;20(1):183. doi: 10.1186/s12890-020-01203-w. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	The diagnostic yield of each procedure.	7 days after procedure
Secondary	Mortality	The 28-day and 60-day of patients in each group.	28 and 60 days
Secondary	Incidence of procedure related adverse events	Procedure related death, procedure related hemodynamic and respiratory instability, airway bleeding, pneumothorax and other procedure related adverse events.	3 days after procedure
Secondary	Hospital stay	Length of hospital stay including ICU and general ward of respiratory medicine.	up to 60 days
Secondary	Organ support	Length of organ support (days).	up to 60 days