Back to resultsTransbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure
Primary Purpose
Acute Respiratory Failure, Acute Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transbronchial lung cryobiopsy
Transbronchial lung biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Respiratory Failure
Eligibility Criteria
Inclusion Criteria: Diagnosis of acute hypoxemic respiratory failure 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 Imaging shows a multi-lobar segmental distribution of ground glass opacity with or without consolidations Patients' families agreed to participate in the study and signed an informed consent form Exclusion Criteria: Significant hemodynamic instability Uncorrectable coagulopathy Severe pulmonary hypertension Acute coronary syndrome Intermediate-high-risk acute pulmonary embolism Acute phase of stroke Severe emphysema Aortic dissection and massive gastrointestinal bleeding Other conditions that are not suitable for participation in the clinical trial
Sites / Locations
- China-Japan Friendship HospitalRecruiting
- The Second Xiangya HospitalRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- The Sixth Hospital of WuhanRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transbronchial lung cryobiopsy
Transbronchial lung biopsy
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic yield
The diagnostic yield of each procedure.
Secondary Outcome Measures
Mortality
The 28-day and 60-day of patients in each group.
Incidence of procedure related adverse events
Procedure related death, procedure related hemodynamic and respiratory instability, airway bleeding, pneumothorax and other procedure related adverse events.
Hospital stay
Length of hospital stay including ICU and general ward of respiratory medicine.
Organ support
Length of organ support (days).
Full Information
NCT ID
NCT05754866
First Posted
February 23, 2023
Last Updated
March 3, 2023
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05754866
Brief Title
Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure
Official Title
Transbronchial Lung Biopsy Versus Transbronchial Lung Cryobiopsy in Critically Ill Patients With Undiagnosed Acute Hypoxemic Respiratory Failure: a Multicenter Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transbronchial lung cryobiopsy
Arm Type
Experimental
Arm Title
Transbronchial lung biopsy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transbronchial lung cryobiopsy
Intervention Description
Lung tissue was obtained by transbronchial lung cryobiopsy for subsequent pathology and clinical diagnosis.
Intervention Type
Procedure
Intervention Name(s)
Transbronchial lung biopsy
Intervention Description
Lung tissue was obtained by transbronchial lung biopsy for subsequent pathology and clinical diagnosis.
Primary Outcome Measure Information:
Title
Diagnostic yield
Description
The diagnostic yield of each procedure.
Time Frame
7 days after procedure
Secondary Outcome Measure Information:
Title
Mortality
Description
The 28-day and 60-day of patients in each group.
Time Frame
28 and 60 days
Title
Incidence of procedure related adverse events
Description
Procedure related death, procedure related hemodynamic and respiratory instability, airway bleeding, pneumothorax and other procedure related adverse events.
Time Frame
3 days after procedure
Title
Hospital stay
Description
Length of hospital stay including ICU and general ward of respiratory medicine.
Time Frame
up to 60 days
Title
Organ support
Description
Length of organ support (days).
Time Frame
up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute hypoxemic respiratory failure
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
Imaging shows a multi-lobar segmental distribution of ground glass opacity with or without consolidations
Patients' families agreed to participate in the study and signed an informed consent form
Exclusion Criteria:
Significant hemodynamic instability
Uncorrectable coagulopathy
Severe pulmonary hypertension
Acute coronary syndrome
Intermediate-high-risk acute pulmonary embolism
Acute phase of stroke
Severe emphysema
Aortic dissection and massive gastrointestinal bleeding
Other conditions that are not suitable for participation in the clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingyuan Zhan, M.D.
Phone
+86-13911785957
Email
drzhanqy@163.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guowu Zhou, M.D.
Phone
+86-13585939427
Email
gwzhou41@163.com
Facility Name
The Second Xiangya Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Luo, M.D.
Phone
+86-13607435199
Email
luohonghuxi@csu.edu.cn
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zuo, M.D.
Phone
+86-15879098337
Email
zuoweincu0108@163.com
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Chen, M.D.
Phone
+86-13771775292
Facility Name
The Sixth Hospital of Wuhan
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fajiu Li, M.M.
Phone
+86-18627933943
Email
80670519@qq.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengying Yao, M.D.
Phone
+86-13592665719
Email
zdyfyricu@qq.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
29521713
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.
Results Reference
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PubMed Identifier
17725820
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.
Results Reference
background
PubMed Identifier
29799835
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.
Results Reference
background
PubMed Identifier
17255856
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.
Results Reference
background
PubMed Identifier
32600302
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.
Results Reference
background
PubMed Identifier
35509092
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.
Results Reference
background
PubMed Identifier
36545213
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.
Results Reference
background
PubMed Identifier
36552923
Citation
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.
Results Reference
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Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure
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