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Completed

NCT Number: NCT05628454

Comparison of Three Different Puncture Techniques in EBUS-TBNA

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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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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.

Other names: Slow-pull capillary technique

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.

Other names: Standard suction

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

Other names: Fine needle sampling without suction

Primary outcomes

  1. Diagnostic accuracy of three different puncture methods according to pathological diagnosis

    Time frame: 6 months

    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.

Secondary outcomes

  1. Blood contamination of samples

    Time frame: 1 week

    Blood contamination was categorized as follows: low (no or few blood cells influencing the diagnosis), moderate (sample partially obscured by blood cells, but pathological diagnosis possible), and high (large numbers of blood cells, rendering pathological diagnosis difficult)

  2. Bleeding of operation

    Time frame: 1 week

    There are three levels of bleeding:Small amount of bleeding（Ⅰ）: Bleeding can stop spontaneously without continuous suction.Moderate bleeding（Ⅱ）: Continuous suction is required, and epinephrine or ice salt water is used locally to stop bleeding.Massive bleeding（Ⅲ）: Patients who need to be used balloon compression, interventional treatment, or blood transfusion treatment or even died of asphyxia due to bleeding.

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

    Time frame: 1 week

    Tissue cores were immersed in formalin solution and subjected to histopathological examination. In the absence of a tissue core, the contents were pressed onto a glass slide, immersed in 96% methanol for ⩾10min and subjected to cytopathological examination.Some methods may only obtain cytological specimens, while others may obtain tissue cores. Tissue cores are better for pathologists to diagnose.

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2022
Registry last updated
Apr 30, 2025

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.

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