Skip to main content
OpenTrials
Completed

NCT Number: NCT04572984

Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Army Medical University, Chongqing, Chongqing Municipality, China

Loading trial locations.

About this study

A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

EBUS-TBMCB

Procedure

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

Primary outcomes

  1. diagnostic yield

    Time frame: through study completion, an average of 1 year

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

  2. prevalence of the procedure-related adverse events

    Time frame: through study completion, an average of 1 year

    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

Secondary outcomes

  1. sample size

    Time frame: through study completion, an average of 1 year

    the area and diameter of sample obtained by each procedure

  2. consumed time

    Time frame: through study completion, an average of 1 year

    duration of each period in each procedure

  3. sample adequacy

    Time frame: through study completion, an average of 1 year

    the ratio of the number of patients with adequate sample by the procedure and the number of all the patients who have undergone this procedure

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Collaborators

  • Heidelberg University

Registry information

Official study title

The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 5, 2020
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.