Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA

Withdrawn

• Conditions: Lung Cancer
• Interventions: Diagnostic Test: Supraclavicular lymph node ultrasound

• Registration Number: NCT03087305
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Study Start: 2017-05-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Supraclavicular lymph node ultrasound	All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer

Primary Outcome Measures

Name	Time	Method
Incidence of supraclavicular metastasis	7 days	Incidence of supraclavicular metastasis

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States