Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA

January 30, 2018 updated by: University of Minnesota

Incidence of Supraclavicular Lymph Node Metastasis in Patients Referred for EBUS-TBNA for Presumed Primary Lung Cancer by Interventional Pulmonologists.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
All patients age 20yrs or greater referred for EBUS-TBNA with suspicion for primary lung cancer
Diagnostic test: Supraclavicular lymph node ultrasound
Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of supraclavicular metastasis
Time Frame: 7 days
Incidence of supraclavicular metastasis
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1703M10502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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