NCT05754866

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

February 23, 2023

Last Update Submit

February 5, 2024

Conditions

Acute Respiratory FailureAcute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    The diagnostic yield of each procedure.

    7 days after procedure

Secondary Outcomes (4)

  • Mortality

    28 and 60 days

  • Incidence of procedure related adverse events

    3 days after procedure

  • Hospital stay

    up to 60 days

  • Organ support

    up to 60 days

Study Arms (2)

Transbronchial lung cryobiopsy

EXPERIMENTAL
Procedure: Transbronchial lung cryobiopsy

Transbronchial lung biopsy

ACTIVE COMPARATOR
Procedure: Transbronchial lung biopsy

Interventions

Transbronchial lung cryobiopsyPROCEDURE

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

Transbronchial lung cryobiopsy
Transbronchial lung biopsyPROCEDURE

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

Transbronchial lung biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

The Second Xiangya Hospital

Changsha, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

The Sixth Hospital of Wuhan

Wuhan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 29521713BACKGROUND

  • 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.

    PMID: 17725820BACKGROUND

  • 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.

    PMID: 29799835BACKGROUND

  • 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.

    PMID: 17255856BACKGROUND

  • 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.

    PMID: 32600302BACKGROUND

  • 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.

    PMID: 35509092BACKGROUND

  • 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.

    PMID: 36545213BACKGROUND

  • 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.

    PMID: 36552923BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Qingyuan Zhan, M.D.

CONTACT

+86-13911785957drzhanqy@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

April 1, 2023

Primary Completion

November 1, 2025

Study Completion

November 30, 2025

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

CN(6)