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

NCT03545256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Cancer T1-N0 or T2-N0 of the Oral Cavity

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Renaud GARREL, ENT · CHU Montpellier Gui de Chauliac Hospital, Neuroscience Head and Neck Pole, ENT Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03545256 on ClinicalTrials.gov