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Trial Title:
Comparison of Three Different Puncture Techniques in EBUS-TBNA
NCT ID:
NCT05628454
Condition:
Lung Cancer
Sarcoidosis
Tuberculosis
Conditions: Official terms:
Tuberculosis
Sarcoidosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
The operator knows which puncture technique to be used, but the subject and the outcomes
assessor does not know the technique.
Intervention:
Intervention type:
Procedure
Intervention name:
Endobronchial ultrasound-guided transbronchial needle Slow-pull capillary sampling
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.
Arm group label:
EBUS-TBNSP
Other name:
Slow-pull capillary technique
Intervention type:
Procedure
Intervention name:
Endobronchial ultrasound-guided transbronchial needle aspiration
Description:
The operation steps are the same as above, but the negative pressure device of 10ml
syringe is connected behind the puncture needle.
Arm group label:
EBUS-TBNA
Other name:
Standard suction
Intervention type:
Procedure
Intervention name:
Endobronchial ultrasound-guided transbronchial needle capillary sampling
Description:
The operation steps are the same as above, but there is no negative pressure device
behind the puncture needle
Arm group label:
EBUS-TBNCS
Other name:
Fine needle sampling without suction
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.
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
Ganggang Yu
Phone:
0086-13717970816
Email:
gangyu.603@163.com
Start date:
November 1, 2022
Completion date:
November 1, 2024
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05628454
