Clinical trial NCT03237195: Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.
Official title: Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection Specimen in Its Entirety.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastasis
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent neck dissection for squamous cell carcinomas of head and neck origin.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of additional lymph nodes obtained with additional sampling of soft tissue
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Associate Professor
name: Varsha Manucha
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillies EM, Luna MA. Histologic evaluation of neck dissection specimens. Otolaryngol Clin North Am. 1998 Oct;31(5):759-71. doi: 10.1016/s0030-6665(05)70085-2.
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. doi: 10.1002/hed.10194.
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.
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: 10.5858/2000-0401-OA.1.
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. doi: 10.1007/BF00179388.