Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma

Endometrial Adenocarcinoma Clinical Trial

Official title:

Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716414
• Other study ID #: 53201016
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: February 16, 2020

Study information

• Verified date: June 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 16, 2020
• Est. primary completion date: February 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adenocarcinoma
• Endometrial Adenocarcinoma
• Endometrial Neoplasms

Intervention

Procedure:
• SLN mapping
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.

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Analysis	Using the final pathological diagnosis as the Gold Standard, the investigators will calculate the sensitivity, specificity, and predictive accuracy of mapping and detection of SLN with metastatic disease.	Within 14 days after the surgery
Secondary	Postoperative complications	calculate the incidence of complications such as lymph cysts, lymph edema, and postoperative fever etc.	1 years after the surgery
Secondary	Recurrence rate	The recurrence rate will be followed up.	5 years after the surgery
Secondary	Adjuvant therapy rate	The adjuvant therapy rate will be followed up.	5 years after the surgery
Secondary	5-year survival rate	The 5-year survival rate will be followed up.	5 years after the surgery