Acquire versus ViziShot needles in Endobronchial Ultrasound Guided Lymph Node Aspiratio

Not Applicable

Recruiting

• Conditions: mediastinal lymphadenopathy; lung cancer; Respiratory - Other respiratory disorders / diseases; Cancer - Lung - Non small cell; Cancer - Lung - Small cell

• Registration Number: ACTRN12621001736831
• Lead Sponsor: Dr Moayed Alawami

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-20
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

All patients referred to Transbronchial Node Aspiration (TBNA) by Endoscopic Ultrasound (EBUS) that meet the following criteria:
- Adults (defined as older than or equal to 18 years of age). There is no upper limit of age provided participants can consent.
- Outpatient/Elective admission to perform the procedure
- Not on anticoagulation (or withheld prior to procedure). Aspirin is ok
- Able to consent
- First TBNA (linear) EBUS (not a redo procedure and no linear EBUS with last 8 weeks).
- Repeat EBUS due to participants intolerance is considered to be failure of bronchoscopy/sedation rather than failure of biopsy needle. The failed procedure results will be not be counted
- At least 1 lymph node size greater or equal to 10 mm

Exclusion Criteria

-Unable to consent, this includes but not limited to participants with dementia, intellectual difficulties, or inability to communicate.
-Contraindication to taking biopsy – ie on anticoagulation or dual antiplatelets therapy within 48 hrs of procedure or INR > 1.5
-Inpatients (due to being sick, likely less time to consider participation and making an informed consent). To clarify, inpatients refer to patients who were admitted via emergency department and does not include elective admission to facilitate a procedure or investigations such as who live far away from Lyell McEwin Hospital.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of diagnostic samples per needle of out all needle aspirations. Samples will be transferred to slides that are examined by on site cytologist and will be denoted as sufficient material or non-sufficient (ie bloods)[Immediately post-aspiration procedure.];Complications related to lymph node aspiration (pneumothorax or haemoptysis or infection or unexpected visit to ED)[Participants will be phoned between 7-10 days post-aspiration procedure to check these outcomes.];Proportions of needle failure (ie how often interventional pulmonologist has to change needle used take biopsy). This will be written by the proceduralist on study specific form immediately post procedure.[Evaluated immediately during procedure and to be written on study specific form.]

Secondary Outcome Measures

Name	Time	Method
Proportions of participants who needed repeat procedure. This will be collected by checking medical records that participants had or did not have a repeat procedure.[Evaluated 6 weeks after aspiration procedure.];Time taken to perform procedure using each needle determined by digital watch.[Immediately post-aspiration procedure.]