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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mediastinal Lymphadenopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EBUS-TBNA-TBMCB

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

Group Type EXPERIMENTAL

EBUS-TBMCB

Intervention Type PROCEDURE

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

EBUS-TBNA

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EBUS-TBMCB

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No