Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA

NCT ID: NCT03087305

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-07-01

Brief Summary

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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

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Supraclavicular lymph node ultrasound

Intervention Type DIAGNOSTIC_TEST

Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA

Interventions

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Supraclavicular lymph node ultrasound

Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Karsell PR, McDougall JC. Diagnostic tests for lung cancer. Mayo Clin Proc. 1993 Mar;68(3):288-96. doi: 10.1016/s0025-6196(12)60051-2.

Reference Type BACKGROUND
PMID: 8474273 (View on PubMed)

Baatenburg de Jong RJ, Rongen RJ, Lameris JS, Harthoorn M, Verwoerd CD, Knegt P. Metastatic neck disease. Palpation vs ultrasound examination. Arch Otolaryngol Head Neck Surg. 1989 Jun;115(6):689-90. doi: 10.1001/archotol.1989.01860300043013.

Reference Type BACKGROUND
PMID: 2655666 (View on PubMed)

Som PM, Curtin HD, Mancuso AA. Imaging-based nodal classification for evaluation of neck metastatic adenopathy. AJR Am J Roentgenol. 2000 Mar;174(3):837-44. doi: 10.2214/ajr.174.3.1740837.

Reference Type BACKGROUND
PMID: 10701636 (View on PubMed)

Tsunodo-Shimizu H, Saida Y. Ultrasonographic visibility of supraclavicular lymph nodes in normal subjects. J Ultrasound Med. 1997 Jul;16(7):481-3. doi: 10.7863/jum.1997.16.7.481.

Reference Type BACKGROUND
PMID: 9315199 (View on PubMed)

Vassallo P, Wernecke K, Roos N, Peters PE. Differentiation of benign from malignant superficial lymphadenopathy: the role of high-resolution US. Radiology. 1992 Apr;183(1):215-20. doi: 10.1148/radiology.183.1.1549675.

Reference Type BACKGROUND
PMID: 1549675 (View on PubMed)

Brantigan JW, Brantigan CO, Brantigan OC. Biopsy of nonpalpable scalene lymph nodes in carcinoma of the lung. Am Rev Respir Dis. 1973 Jun;107(6):962-74. doi: 10.1164/arrd.1973.107.6.962. No abstract available.

Reference Type BACKGROUND
PMID: 4712440 (View on PubMed)

van Overhagen H, Brakel K, Heijenbrok MW, van Kasteren JH, van de Moosdijk CN, Roldaan AC, van Gils AP, Hansen BE. Metastases in supraclavicular lymph nodes in lung cancer: assessment with palpation, US, and CT. Radiology. 2004 Jul;232(1):75-80. doi: 10.1148/radiol.2321030663. Epub 2004 May 27.

Reference Type BACKGROUND
PMID: 15166326 (View on PubMed)

Kumaran M, Benamore RE, Vaidhyanath R, Muller S, Richards CJ, Peake MD, Entwisle JJ. Ultrasound guided cytological aspiration of supraclavicular lymph nodes in patients with suspected lung cancer. Thorax. 2005 Mar;60(3):229-33. doi: 10.1136/thx.2004.029223.

Reference Type BACKGROUND
PMID: 15741441 (View on PubMed)

Kendirlinan R, Ozkan G, Bayram M, Bakan ND, Tutar M, Gur A, Camsari G. Ultrasound guided fine-needle aspiration biopsy of metastases in nonpalpable supraclavicular lymph nodes in lung cancer patients. Multidiscip Respir Med. 2011 Aug 31;6(4):220-5. doi: 10.1186/2049-6958-6-4-220.

Reference Type BACKGROUND
PMID: 22958429 (View on PubMed)

Chang DB, Yang PC, Yu CJ, Kuo SH, Lee YC, Luh KT. Ultrasonography and ultrasonographically guided fine-needle aspiration biopsy of impalpable cervical lymph nodes in patients with non-small cell lung cancer. Cancer. 1992 Sep 1;70(5):1111-4. doi: 10.1002/1097-0142(19920901)70:53.0.co;2-4.

Reference Type BACKGROUND
PMID: 1325269 (View on PubMed)

Fultz PJ, Feins RH, Strang JG, Wandtke JC, Johnstone DW, Watson TJ, Gottlieb RH, Voci SL, Rubens DJ. Detection and diagnosis of nonpalpable supraclavicular lymph nodes in lung cancer at CT and US. Radiology. 2002 Jan;222(1):245-51. doi: 10.1148/radiol.2221010431.

Reference Type BACKGROUND
PMID: 11756733 (View on PubMed)

Lee JD, Ginsberg RJ. Lung cancer staging: the value of ipsilateral scalene lymph node biopsy performed at mediastinoscopy. Ann Thorac Surg. 1996 Aug;62(2):338-41.

Reference Type BACKGROUND
PMID: 8694587 (View on PubMed)

Other Identifiers

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1703M10502

Identifier Type: -

Identifier Source: org_study_id

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