Comparison of Three Different Puncture Techniques in EBUS-TBNA

NCT05628454 | Completed

• 1 other identifier: BFH20221019005
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Sarcoidosis; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of three different puncture methods according to pathological diagnosis

  The final pathological diagnosis was based on all available cytological and histological samples. In cases with negative pathological results , we continue to follow up the patients for ⩾6months.

  6 months

Secondary Outcomes (3)

• Blood contamination of samples

  1 week

• Bleeding of operation

  1 week

• Acquisition of tissue core of three different puncture methods according to the judgment of the pathologist

  1 week

Study Arms (3)

EBUS-TBNSP

EXPERIMENTAL

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.

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

EBUS-TBNA

EXPERIMENTAL

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

Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration

EBUS-TBNCS

EXPERIMENTAL

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

Procedure: Endobronchial ultrasound-guided transbronchial needle capillary sampling

Interventions

Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling 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.

Also known as: Slow-pull capillary technique

EBUS-TBNSP

Endobronchial ultrasound-guided transbronchial needle aspiration PROCEDURE

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

Also known as: Standard suction

EBUS-TBNA

Endobronchial ultrasound-guided transbronchial needle capillary sampling PROCEDURE

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

Also known as: Fine needle sampling without suction

EBUS-TBNCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (1)

• Wu Y, Xu R, Duan X, Deng Y, Yu G, He X, Yao Z. Comparison of three different puncture techniques for endobronchial ultrasound transbronchial needle aspiration: a single-center, prospective, randomized controlled study. BMC Pulm Med. 2025 Sep 30;25(1):437. doi: 10.1186/s12890-025-03917-1.

  PMID: 41029266 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Sarcoidosis; Tuberculosis

Interventions

Suction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Yanjun Wu

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Zhigang Yao

  Beijing Friendship Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operator knows which puncture technique to be used, but the subject and the outcomes assessor does not know the technique.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 28, 2022
• Study Start: November 8, 2022
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 30, 2025

Record last verified: 2024-11

Locations

CN (1)