Clinical trial NCT03716414: Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Official title: Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Adenocarcinoma
Keywords: Sentinel lymph node
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 18\~100 years.
2. No contraindication to surgery.
3. Signed and dated informed consent.
4. high-risk endometrial cancer with grade 3, deep myometrial invasion, non-endometrioid endometrial cancer, and Cervical invasion (in intraoperative frozen section examinations).
5. With any suspicious pelvic, para-aortic or distant lymph node metastasis in preoperative imaging tests including MRI/CT/positron emission computed tomography(PET)-CT.

Exclusion Criteria:

1. Low-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter \< 2cm (in intraoperative frozen section examinations).
2. Intermediate-risk endometrioid endometrial cancer with grade 1-2, superficial myometrial invasion and tumor diameter ≥ 2cm (in intraoperative frozen section examinations).

Primary outcomes:
measure: Performance Analysis
timeFrame: Within 14 days after the surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: 1 years after the surgery
measure: Recurrence rate
timeFrame: 5 years after the surgery
measure: Adjuvant therapy rate
timeFrame: 5 years after the surgery
measure: 5-year survival rate
timeFrame: 5 years after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital, Fudan University
Study officials:
affiliation: Obstetrics and Gynecology Hospital, Fudan University
name: Chao Wang, Ph.D.
role: STUDY_DIRECTOR
affiliation: Obstetrics and Gynecology Hospital, Fudan University
name: Xuezhen Luo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrics and Gynecology Hospital, Fudan University
name: Xiaojun Chen, Ph.D.
role: STUDY_CHAIR
References: