Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-09 @ 8:45 PM
Study NCT ID:
NCT03087305
Status:
WITHDRAWN
Last Update Posted:
2018-02-01
First Post:
2017-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: