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N/A Completed N=61 Randomized Double-blind Diagnostic

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle

Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma · Lung Cancer
Source: ClinicalTrials.gov NCT03004586 ↗
Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Percentage of Lymph Nodes With Adequate Samples — 79; 78.5 Percentage of Lymph Nodes

Summary

The goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) instead of a standard 22-gauge needle. The safety of the needles will also be studied.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Lymph Nodes With Adequate Samples
79; 78.5
SECONDARY
Concordance With the Final Diagnosis
82; 80.5
SECONDARY
Usability of the Needle
4.27; 4.95; 4.58; 4.00; 4.40; 4.65

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Indication for EBUS-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes.

Exclusion Criteria

  • Patients who are pregnant or lactating
  • Inability to give informed consent
  • Patients in which only one lymph node station is expected to be sampled by the performing clinician.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03004586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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