Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Condition: Endometrial Adenocarcinoma
MeSH terms: Endometrial Neoplasms
Study type: Observational

Summary: 
      To evaluate the efficacy of sentinel lymph node biopsy technique in patients with high-risk
      endometrial carcinoma, which provides the evidence that sentinel lymph node biopsy technique
      could substitute the systematic Lymph node dissection(LND).
    

Detailed description: 
      Comprehensive surgical staging for endometrial carcinoma(EC) is an indisputable staging and
      prognostic tool. The staging procedure includes total hysterectomy, bilateral
      salpingo-oophorectomy, and lymphadenectomy, omental biopsy if necessary. Since lymph node
      metastasis is one of the most important risk factors of prognosis. The dissection of lymph
      nodes has been used for staging, prognostic information, and to determine the need for
      adjuvant therapy. The approach to lymph node evaluation in women with EC is still a subject
      of debate. Practice varies across different institutions or surgeons. In general, the options
      for management of retroperitoneal lymph nodes include no lymph node dissection (LND),
      systematic LND only if the risk of lymph node metastasis exceeds a certain threshold, or
      routine sentinel LND following lymphatic mapping. lymphadenectomy is significantly associated
      with longer operating time, higher surgical costs, greater rate of infection, as well as the
      occurrence of lymphocysts and lymphedema, moreover, there is lack of evidence of a
      therapeutic benefit of LND, less invasive techniques have emerged as possible alternatives.
      The technique for lymphatic mapping and sentinel lymph node dissection (SLND) in EC has been
      refined and found a low false-negative rate for detection of positive lymph nodes. The 2018
      National Comprehensive cancer Network (NCCN) guideline of uterus cancer states SLN mapping
      can be considered for the surgical staging of apparent uterine-confined malignancy when there
      is no metastasis demonstrated by imaging studies or no obvious extrauterine disease at
      exploration. It indicates low-risk patients could avoid those side effects of the systematic
      Lymph node dissection. Whether high-risk patients (grade 3, deep myometrial invasion,
      non-endometrioid endometrial cancer, and Cervical invasion) can be benefited from this
      technique? This prospective cohort study is designed to To evaluate the efficacy of sentinel
      lymph node biopsy technique in patients with high-risk endometrial carcinoma. Surgery should
      be performed within a maximum of 4 weeks from the patient's first consultation.
    

Intervention name(s): SLN mapping
Intervention type(s): Procedure
Intervention description(s): Intra-operative SLN mapping with indocyanine green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and Arms Assigned Interventions another 1ml will be injected superficially (2mm-depth).
The time between the injection and the search for SLN must be as soon as possible.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18-100 years old with high-risk endometrial carcinoma (grade 3 endometroid
        endometrial cancer, deep myometrial invasion, non-endometrioid endometrial cancer, and
        Cervical invasion (in intraoperative frozen section examinations) and without no
        contraindication to surgery will be recruited.
      
Keywords: Sentinel lymph node