Neoplasms

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Head and Neck Neoplasms

Neoplasm Metastasis

Quality of Life

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.

Renaud GARREL, ENT

César CARTIER, ENT

Angelina MARTINEZ, Site Study Coordinator

Claire LEMAIRE, Study Nurse Manager

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.

Currently, patients with oral cancer or oropharynx T1-N0 or T2-N0 are treated by surgery on the tumor and the neck, both validated techniques are either with a systematic lymph node dissection or a search for lymph sentinel node (GS). The goal on the lymph sentinel nodes is to diagnose the presence of metastasis (s). With the GS technique, the length of hospital stay can be shorter. The limited invasiveness of tumor surgery of the oral cavity and oropharynx and GS and short postoperative monitoring is compatible with outpatient management, so it should be evaluated through a study clinical.

The main objective of this study is to evaluate the rate of conversion to complete hospitalization or re-hospitalization within 10 days of surgery J0. The secondary objectives are the evaluation of the acceptance rate of outpatient surgery by the eligible patient, complications related to outpatient management, the quality of life of the patient and the cost of the strategy over the first month following J0.

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 or 3-minute CT image acquisition is performed 30 to 60 minutes after injection in anteroposterior and lateral view to identify the sentinel lymph nodes (GS(s)) which are then marked on the skin with an indelible marker. This routine care examination is done in an external act.

- 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 General anesthesia.

The main tumor is operated by mouth. The ganglionic surgical procedure consists of the removal of the GS(s) by a limited cervical approach, following a cervical dissection line. The GS(s) are identified by a gamma detection probe, equipped with a high-resolution collimator whose tip is covered with a sterile disposable sleeve. Exeresis of the GS(s) is performed by removing the peri-ganglionic cellular tissue and avoiding any capsular intrusion. The GS lymph node (s) so taken is sent freshly by special request to the pathologist for final analysis according to the recommended procedure for GS.

The cervical dissection will be performed later if the definitive analysis finds a ganglionic invasion. In this case, the patient will be re-hospitalized in unit full hospitalization for cervical lymph node dissection: the ganglionic areas systematically concerned are the levels I, II, III and IV for tumors of the oral cavity and II, III and IV for the oropharynx. The gesture will be bilateral if the lymphoscintigraphy had found a bilateral drains. The cervical dissection parts are labeled and sent for routine final pathological analysis.

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, nanocolloide labeled with technetium99, around the primary tumor.

- 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.

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

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

the conversion into complete hospitalization on the day of the procedure (Day 0) or re-hospitalization within 10 days following the surgical procedure (Day 0) respectively will be performed in case of medical or surgical complications or according to the doctor's opinion for the release of the patient, or in case of lymph nodes dissection

Acceptance rate of outpatient surgery validated by the multidisciplinary meeting and proposed to the patient who meets the eligibility criteria for the inclusion visit

All complications related to outpatient care will be recorded

self-questionnaire completed by the patient at inclusion visit, Score reported by the subjects on the Quality of life questionnaire QLQ-C30. The scores of the different scales are between 0 and 100. A score of the overall health of quality of life (QoL) close to 100 indicates a QoL close to perfect health. Similarly, a score of a functional scale close to 100 represents a level close to perfect capacity.

self-questionnaire completed by the patient at visit Day 0 visit, Scores reported by the subjects on the Quality of life questionnaires QLQ-H \& N35.

The questionnaire EORTC QLQ- H \& N35 contains 35 questions that incorporate 7 multidimensional scales that assess pain, swallowing, senses (taste and smell), speech, socializing, social contacts, and sexuality during the previous week. It also includes 11 isolated items.

The scoring approach for the QLQ-H \& N35 questionnaire is identical in principle to that of the QLQC30 questionnaire symptom scales.

self-questionnaire completed by the patient at visit Day 10 visit, Scores reported by the subjects on the Quality of life questionnaires QLQ-H \& N35.

The questionnaire EORTC QLQ- H \& N35 contains 35 questions that incorporate 7 multidimensional scales that assess pain, swallowing, senses (taste and smell), speech, socializing, social contacts, and sexuality during the previous week. It also includes 11 isolated items.

The scoring approach for the QLQ-H \& N35 questionnaire is identical in principle to that of the QLQC30 questionnaire symptom scales.

self-questionnaire completed by the patient at inclusion Month 1 visit. Scores reported by the subjects on the Quality of life questionnaire SF-36.Score from the worst health condition imaginable (0) to the best state of health imaginable (100).

Description: The cost will be evaluated on the first month of outpatient management

Spots Global Cancer Trial Database for economical study