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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Tuberculosis; Sarcoidosis
• Intervention / Treatment: Procedure: Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling; Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration; Procedure: Endobronchial ultrasound-guided transbronchial needle capillary sampling

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin He; Phone Number: 0086-15801309510; Email: cynthia_cruise@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Ganggang Yu; Phone Number: 0086-13717970816; Email: gangyu.603@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.; Other Names: Slow-pull capillary technique
Experimental: EBUS-TBNA; 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; 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
Experimental: EBUS-TBNCS; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood contamination of samples	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)	1 week
Bleeding of operation	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.	1 week
Acquisition of tissue core of three different puncture methods according to the judgment of the pathologist	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.	1 week

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Yanjun Wu, Beijing Friendship Hospital; Study Director: Zhigang Yao, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Lymphoproliferative Disorders; Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Sarcoidosis
• Other Study ID Numbers: BFH20221019005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No