Clinical trial NCT03087305: Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA
Official title: Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: Interventional Pulmonary
EBUS-TBNA
Lung cancer staging
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer

Brief summary: Evaluation of the anatomic extent of a primary lung cancer and presence of metastasis are essential for selection of an appropriate management strategy. Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is a reliable and established technique to evaluate involvement of mediastinal lymph nodes (LN); however, it is an invasive procedure and may not be tolerated in patients with severe underlying lung disease. One exception is the superficially located supraclavicular lymph nodes (SCLN), which can easily be biopsied with percutaneous US-guided-fine needle aspiration (US-FNA). Traditionally, this nodal group is evaluated by palpation; however, literature suggests that palpation itself fails to capture 66% of proven disease by cytology, which challenges the acceptance that non-palpable nodes are indicative of absent disease. Since all palpable SCLN are biopsied to rule out metastasis, we may potentially up-stage more patients using ultrasound evaluation for non-palpable nodes; and offer more appropriate management. Currently, the incidence for non-palpable SCLN metastasis has not been defined in this patient population presenting for EBUS-TBNA. The primary objective is to determine the incidence of supraclavicular lymph node metastasis by ultrasound evaluation in patients referred for EBUS-TBNA.


Eligibility criteria: Inclusion Criteria:

* All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer

Exclusion Criteria:

1. Refusal to sign consent
2. Signs of skin infection along the neck
3. Adults who lack the capacity to sign consent.

Primary outcomes:
measure: Incidence of supraclavicular metastasis
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
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