Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure
NCT ID: NCT05754866
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-04-01
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Transbronchial lung cryobiopsy
Transbronchial lung cryobiopsy
Lung tissue was obtained by transbronchial lung cryobiopsy for subsequent pathology and clinical diagnosis.
Transbronchial lung biopsy
Transbronchial lung biopsy
Lung tissue was obtained by transbronchial lung biopsy for subsequent pathology and clinical diagnosis.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Shiyao Wang
Attending Physician
Locations
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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, , China
Countries
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Central Contacts
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Facility Contacts
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Wei Chen, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CJFH-2022-KY-194
Identifier Type: -
Identifier Source: org_study_id
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