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RECRUITING
NCT03545256
NA

Sentinel. Ambulatory. Oral Cavity. Oropharynx (S.A.C.O)

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

Summary

This is a single-center pilot study of open-label, non-randomized interventional research based on the outpatient management of 30 patients with T1-N0 or T2-N0 cancer in the oral cavity or oropharynx.

Official title: Open Non-randomized Study on the Management of Operable T1-N0 or T2-N0 Oral Cavity and Oropharynx Cancer and Sentinel Lymph Node in Outpatient Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2018-05-31

Completion Date

2026-07-01

Last Updated

2025-09-30

Healthy Volunteers

No

Interventions

PROCEDURE

outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search

The surgical procedure associated with the sentinel lymph node technique is carried out in two stages: \- Lymphoscintigraphy at Day-1 : This is the identification of the lymphatic network of the patient by a prior injection of radioactive tracer, nanocolloids labeled with technetium99, around the primary tumor. A planar CT image acquisition is performed to identify the sentinel lymph nodes (Gs(s)) which are then marked on the skin with an indelible marker. Surgery on D0: The patient is admitted to the hospital at 7:00 am in outpatient unit. He is reviewed by the anesthetist before the intervention and is transferred to the operating room for the intervention under AG. The main tumor is operated by mouth.

Locations (1)

Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche

Montpellier, Hérault, France