Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure

NCT ID: NCT05754866

Last Updated: 2024-02-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Respiratory Failure Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transbronchial lung cryobiopsy

Group Type EXPERIMENTAL

Transbronchial lung cryobiopsy

Intervention Type PROCEDURE

Lung tissue was obtained by transbronchial lung cryobiopsy for subsequent pathology and clinical diagnosis.

Transbronchial lung biopsy

Group Type ACTIVE_COMPARATOR

Transbronchial lung biopsy

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Transbronchial lung biopsy

Lung tissue was obtained by transbronchial lung biopsy for subsequent pathology and clinical diagnosis.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shiyao Wang

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China-Japan Friendship Hospital

Beijing, , China

Site Status RECRUITING

The Second Xiangya Hospital

Changsha, , China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Site Status RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status RECRUITING

The Sixth Hospital of Wuhan

Wuhan, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qingyuan Zhan, M.D.

Role: CONTACT

+86-13911785957

Facility Contacts

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Guowu Zhou, M.D.

Role: primary

+86-13585939427

Hong Luo, M.D.

Role: primary

+86-13607435199

Wei Zuo, M.D.

Role: primary

+86-15879098337

Wei Chen, M.D.

Role: primary

+86-13771775292

Fajiu Li, M.M.

Role: primary

+86-18627933943

Mengying Yao, M.D.

Role: primary

+86-13592665719

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.

Reference Type BACKGROUND
PMID: 29521713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17725820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29799835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17255856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32600302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35509092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36545213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36552923 (View on PubMed)

Other Identifiers

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CJFH-2022-KY-194

Identifier Type: -

Identifier Source: org_study_id

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