NCT04572984

Brief Summary

The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
271

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
2 countries

2 active sites

Status
completed

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

September 12, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

September 12, 2020

Last Update Submit

October 8, 2022

Conditions

Mediastinal Lymphadenopathy

Outcome Measures

Primary Outcomes (2)

  • diagnostic yield

    percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm

    through study completion, an average of 1 year

  • prevalence of the procedure-related adverse events

    the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • sample size

    through study completion, an average of 1 year

  • consumed time

    through study completion, an average of 1 year

  • sample adequacy

    through study completion, an average of 1 year

Study Arms (2)

EBUS-TBNA-TBMCB

EXPERIMENTAL

endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was followed by endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB)

Procedure: EBUS-TBMCB

EBUS-TBNA

NO INTERVENTION

endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was performed

Interventions

EBUS-TBMCBPROCEDURE

endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA

EBUS-TBNA-TBMCB

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=15 years;
  • More than one mediastinal lesions with diameter \>= 1cm was detected by thoracic CT;
  • Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
  • Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
  • Informed consent form achievement.

You may not qualify if:

  • Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
  • Failure to detect the mediastinal lesions in ultrasonic landscape;
  • Cysts or abscess;
  • Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
  • Psychiatric disorders or severe neurosis.
  • Participation in other clinical experiments in recent 3 months;
  • Any other conditions considered to be inappropriate to be involved in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Army Medical University

Chongqing, Chongqing Municipality, 400037, China

Location

Thoraxklinik - Heidelberg University Hospital

Heidelberg, Baden-Wurttemberg, Germany

Location

Related Publications (1)

  • Fan Y, Zhang AM, Wu XL, Huang ZS, Kontogianni K, Sun K, Fu WL, Wu N, Kuebler WM, Herth FJF. Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial. Lancet Respir Med. 2023 Mar;11(3):256-264. doi: 10.1016/S2213-2600(22)00392-7. Epub 2022 Oct 22.

    PMID: 36279880DERIVED

Study Officials

  • Ye Fan, PhD

    Third Military Medical University

    PRINCIPAL INVESTIGATOR

  • Felix Herth

    Thoraxklinik - Heidelberg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2020

First Posted

October 5, 2020

Study Start

October 1, 2020

Primary Completion

April 1, 2022

Study Completion

April 30, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)DE(1)