Comparison of Three Different Puncture Techniques in EBUS-TBNA

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2024-11-01

Brief Summary

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The purpose of this study was to compare the accuracy and sensitivity of slow-pull capillary technique, traditional suction aspiration and non negative pressure puncture in the diagnosis of mediastinal and/or hilar lymph node enlargement by ultrasound bronchoscopic lymph node biopsy.

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Detailed Description

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EBUS-TBNA has been widely used in the diagnosis of diseases involving lung hilar and mediastinal lymph node enlargement.But different puncture methods are still controversial. Research shows that there was no significant difference in sample adequacy, diagnostic specificity and accuracy between the no negative pressure aspiration and traditional negative pressure aspiration technique.Slow-pull capillary technique is a relatively new operating method of endoscopic ultrasound guided fine needle biopsy in recent years. At present, this technology is widely used in pancreatic space occupying lesions. Compared with the traditional negative pressure aspiration method, our previous retrospective study found that the slow-pull capillary technique can improve the diagnostic accuracy of patients. Therefore, the purpose of this study is to prospectively and randomly compare the advantages and disadvantages of three puncture methods in EBUS-TBNA.

Conditions

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Lung Cancer Sarcoidosis Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The operator knows which puncture technique to be used, but the subject and the outcomes assessor does not know the technique.

Study Groups

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EBUS-TBNSP

The slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure.

Group Type EXPERIMENTAL

Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling

Intervention Type PROCEDURE

The slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure.

EBUS-TBNA

The operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle.

Group Type EXPERIMENTAL

Endobronchial ultrasound-guided transbronchial needle aspiration

Intervention Type PROCEDURE

The operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle.

EBUS-TBNCS

The operation steps are the same as above, but there is no negative pressure device behind the puncture needle

Group Type EXPERIMENTAL

Endobronchial ultrasound-guided transbronchial needle capillary sampling

Intervention Type PROCEDURE

The operation steps are the same as above, but there is no negative pressure device behind the puncture needle

Interventions

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Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling

The slow-pull capillary technique was performed as follows: after identification and measurement of the target lymph node, a needle was used to puncture the lymph node with the stylet in place.At the same time, the stylet was slowly and continuously pulled to create weak negative pressure.

Intervention Type PROCEDURE

Endobronchial ultrasound-guided transbronchial needle aspiration

The operation steps are the same as above, but the negative pressure device of 10ml syringe is connected behind the puncture needle.

Intervention Type PROCEDURE

Endobronchial ultrasound-guided transbronchial needle capillary sampling

The operation steps are the same as above, but there is no negative pressure device behind the puncture needle

Intervention Type PROCEDURE

Other Intervention Names

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Slow-pull capillary technique Standard suction Fine needle sampling without suction

Eligibility Criteria

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Inclusion Criteria

* Age 18-80years
* Chest computed tomography showing hilar or mediastinal lymph node enlargement
* No contraindications for bronchoscopy
* Signed informed consent provided by the patient
* Disease needs to be diagnosed through the EBUS-TBNA

Exclusion Criteria

* Severe coagulation dysfunction
* Severe cardiopulmonary dysfunction
* Acute asthma attack or massive haemoptysis
* Poor general condition
* Physical weakness without tolerance for anaesthesia or allergy to narcotic drug
* Disease can be diagnosed by other less invasive methods (such as skin or peripheral superficial lymph node biopsy)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No