Comparison of Three Different Puncture Techniques in EBUS-TBNA

Capital Medical University

Status: Completed

Conditions: Sarcoidosis; Tuberculosis; Lung Cancer

Treatments: Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration; Procedure: Endobronchial ultrasound-guided transbronchial needle capillary sampling; Procedure: Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT05628454

BFH20221019005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

EBUS-TBNSP

Experimental group

Description:

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.

Treatment:

Procedure: Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling

EBUS-TBNA

Experimental group

Description:

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

Treatment:

Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration

EBUS-TBNCS

Experimental group

Description:

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

Treatment:

Procedure: Endobronchial ultrasound-guided transbronchial needle capillary sampling