Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.

Metastasis Clinical Trial

Official title:

Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection Specimen in Its Entirety.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237195
• Other study ID #: 2016-0288
• Status: Completed
• Phase: N/A
• First received: July 28, 2017
• Last updated: February 16, 2018
• Start date: January 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Most patients with cancer of the head and neck are offered surgical resection of the primary tumor. In order to determine how the tumor will eventually behave, along with the resection of the primary tumor, lymph nodes present in the neck are also dissected. Different institutes have different protocol on handling of the specimen that is received by the pathology labs after dissection of the neck. The investigators intend to analyze the protocol that they use to evaluate the neck dissection specimen.

Description:

This will be a retrospective study. All neck dissections received in the histology laboratory from Jan 2013 to December 2016 will be retrieved from the histopathology files by conducting a search through CoPath. The glass slides of all the neck dissections that fit the study criterion will be retrieved from the archives. The glass slides will be reviewed by the pathologist.

At the time of review number of lymph nodes identified microscopically, presence or absence of metastasis and if the Lymph Nodes (LN) were palpable or not palpable will be documented. The data will be analyzed to see if the submission of extra fat yielded any additional positive lymph nodes or microscopic deposits. The cost analysis for additional slides will be also done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Neck dissection (unilateral and/or bilateral)

2. Primary squamous cell carcinoma of head and neck

Exclusion Criteria:

1. Any neck dissection performed outside UMMC and case received as a consult.

Related Conditions & MeSH terms

• Metastasis

Intervention

Other:
• additional soft tissue in neck dissections
Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gillies EM, Luna MA. Histologic evaluation of neck dissection specimens. Otolaryngol Clin North Am. 1998 Oct;31(5):759-71. Review. — View Citation

Jose J, Coatesworth AP, MacLennan K. Cervical metastases in upper aerodigestive tract squamous cell carcinoma: histopathologic analysis and reporting. Head Neck. 2003 Mar;25(3):194-7. — View Citation

Muirhead D, Aoun P, Powell M, Juncker F, Mollerup J. Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory. Arch Pathol Lab Med. 2010 Aug;134(8):1164-9. doi: 10.1043/2000-0401-OA.1. — View Citation

Seethala RR. Current state of neck dissection in the United States. Head Neck Pathol. 2009 Sep;3(3):238-45. doi: 10.1007/s12105-009-0129-y. Epub 2009 Aug 7. Review. — View Citation

van den Brekel MW, Stel HV, van der Valk P, van der Waal I, Meyer CJ, Snow GB. Micrometastases from squamous cell carcinoma in neck dissection specimens. Eur Arch Otorhinolaryngol. 1992;249(6):349-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of additional lymph nodes obtained with additional sampling of soft tissue	Number of additional lymph nodes obtained with additional sampling of soft tissue	3 years