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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years old with no upper age limit
- •Patient (s) affiliated to a social security system, or beneficiary of such a system
- •Patient information and informed consent signed by the patient
- •Patient no longer participating in another trial since legal time
- •Patient with primary squamous cell carcinoma of the oral cavity or oropharynx documented by biopsy with histological analysis less than 1 month old
- •Tumor operable by TNM stage, location and general condition of the patient
- •Systematic Oto-Rhino-Laryngology panendoscopy eliminating a second synchronous tumor and establishing precisely the T
- •Stage T1 or T2, N0 and M0
- •Proposal by a multidisciplinary meeting for tumor surgery and GS technique
- •Eligibility criteria for ambulatory surgery present
- •Anesthetic criteria for eligibility for outpatient hospitalization (ref AFAR 29 (2010) 67-72, formalized expert recommendations) including ASA I, II and III score stable
- •Patient able to understand the nature, purpose and methodology of the study
排除标准
- •lack of one of the inclusion criteria
- •other cancer being treated
- •non-infiltrating tumor: high grade dysplasia, carcinoma in situ
- •insufficient tumor excision: invaded margins without complementary recovery in healthy zone
- •contraindication to sentinel lymph node surgery or ganglion dissection
- •contraindication to radiotherapy
- •contraindications to performing a scintigraphy:
- •Known allergy or intolerance to the injected product and in particular to Technetium-99
- •Pregnancy
- •Refusal to accept the entire treatment (nodal diagnosis on GS, lymph node dissection pN + follow-up of adjuvant radiotherapy if necessary)
- •impossible to follow over 2 years
- •refusal to accept the monitoring described and / or to provide the information necessary for the study
- •patient already treated for this tumor outside of an excisional biopsy
- •patient who previously had chemotherapy or immunotherapy for another cancer outside the VADS in a period of less than 6 months
- •patient who has had cervical or VADS radiotherapy regardless of the cause or delay
- •patient who has had previous cervical surgery regardless of cause or delay
- •Patient protected by law (patient under guardianship).
- •Patient (e) deprived of liberty by administrative decision.
- •Pregnant or lactating women according to article L1121-5 of the CSP. An assay of βHCG will be performed routinely to ensure the absence of pregnancy.
研究组 & 干预措施
T1-N0 or T2-N0 cancers of the oral cavity
outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search
干预措施: outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search (Procedure)
结局指标
主要结局
Conversion rate in complete hospitalization or re-hospitalization within 10 days following the surgical procedure (D0)
时间窗: From Day 0 to 10 days post 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
次要结局
- Evaluation of the cost of the strategy at Month 1(Month 1)
- Description of complications attributable to outpatient care taken on Day 0, Day 10 and Month1(From Day 0 to Month 1 post surgery)
- Quality of life at inclusion visit(Inclusion visit)
- Quality of life at Day 10 post surgery(Day 10 visit post surgery)
- Acceptance rate of outpatient surgery(inclusion visit)
- Quality of life at month 1 post surgery(Month 1 visit post surgery)
- Quality of life at Day 0 visit(Day 0 visit)