Clinical trial NCT05628454: Comparison of Three Different Puncture Techniques in EBUS-TBNA
Official title: Comparison of Three Different Puncture Techniques in EBUS-TBNA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Sarcoidosis
Tuberculosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

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)

Primary outcomes:
measure: Diagnostic accuracy of three different puncture methods according to pathological diagnosis
timeFrame: 6 months
Secondary outcomes:
measure: Blood contamination of samples
timeFrame: 1 week
measure: Bleeding of operation
timeFrame: 1 week
measure: Acquisition of tissue core of three different puncture methods according to the judgment of the pathologist
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Yanjun Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Zhigang Yao
role: STUDY_DIRECTOR
References: