Incidence of SCLN Metastasis in Patients Referred for EBUS-TBNA

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03087305
• Other study ID #: 1703M10502
• Status: Withdrawn
• Phase: N/A
• First received: March 15, 2017
• Last updated: January 30, 2018
• Start date: May 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Supraclavicular lymph node ultrasound
Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

Baatenburg de Jong RJ, Rongen RJ, Laméris 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Karsell PR, McDougall JC. Diagnostic tests for lung cancer. Mayo Clin Proc. 1993 Mar;68(3):288-96. Review. — View Citation

Kendirlinan R, Ozkan G, Bayram M, Bakan ND, Tutar M, Gür 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Tsunodo-Shimizu H, Saida Y. Ultrasonographic visibility of supraclavicular lymph nodes in normal subjects. J Ultrasound Med. 1997 Jul;16(7):481-3. — View Citation

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. Epub 2004 May 27. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of supraclavicular metastasis	Incidence of supraclavicular metastasis	7 days