Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03727594

Enrollment

Registered

2018-11-01

Start date

2016-01-31

Completion date

2021-01-31

Last updated

2018-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma

Brief summary

The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

Inclusion criteria

* accepted informed consent * preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma * patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)

Exclusion criteria

* rejected informed consent * patients not fit to surgery (according to the general health condition and the clinical tumor stage) * pregnant women

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy	5 years	—
Number of metastasis or micrometastasis in the sentinel lymphnodes identified through immunofluorescence analysis of pancytokeratins	5 years	—
Overall survival	5 years	Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.
Disease-free survival	5 years	Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.

Countries

Italy

Contacts

Primary ContactNicola Malagutti, MD

nicolamalagutti@gmail.com+393339011406

Outcome results