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

Completed

• Conditions: Metastasis

• Registration Number: NCT03237195
• Lead Sponsor: University of Mississippi Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2016-12-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Study Completion: 2017-12-31
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of additional lymph nodes obtained with additional sampling of soft tissue	3 years	Number of additional lymph nodes obtained with additional sampling of soft tissue

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States