Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-26

Study Completion Date

2029-12-01

Brief Summary

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Through this clinical trial, the investigators aim to verify the usefulness and stability of sentinel lymph node mapping in endometrial cancer of clinical stage I-II.

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Detailed Description

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The standard treatment for endometrial cancer is total hysterectomy and bilateral salpingo-oophorectomy, peritoneal cytology, and lymph node dissection. Pelvic lymph node dissection helps to set accurate staging and adjuvant therapy group, but it has never been proven to have therapeutic effects by itself. According to the results of two recent randomized clinical trials, routine pelvic lymph node dissection in early stage endometrial cancer doesn't improve survival rates.

Routine pelvic lymph node detection can cause complications in a large number of patients and is associated with poor quality of life. Therefore, it is important to develop a method that can check the status of the lymph node in a less invasive way. Efforts have been made to preserve other lymph nodes with significantly less potential for metastasis through less invasive methods, reducing lymph edema and complications such as bleeding and nerve damage caused by excessive surgery.

Sentinel lymph node dissection is used as a standard treatment for breast cancer and malignant melanoma, and efforts to develop it have recently continued in endometrial cancer and cervical cancer. A SENTICOL study conducted in cervical cancer patients showed a false-negative rate of 0% when both were monitored lymph node dissection. In addition, unlike routine pelvic lymph node dissection, ultra-staging through 0,2mm gas intercepts allow additional detection of less than 2mm of microtransfer or less than 0.2mm of independent tumor cells that have not been found before. In a recent large-scale prospective study of endometrial cancer, sentinel lymph node mapping using indocyanine green and fluorescent imaging was successful at 86%, and sensitivity (patient-by-patient analysis) reported 100% in diagnosis of lymph node metastasis.

As laparoscopic and robotic surgery account for most of the treatment of endometrial cancer patients, a good environment is created for monitoring lymph node exploration using ICG, and sensitivity and detection rate seem to have improved compared to the previous method. However, there has been no prospective study on the effects of patient clinical prognosis, such as a standard treatment, pelvic lymph node resection, and disease-free survival rate, and overall survival rate, so a prospective study is essential. The investigators compare survival rates in the group that does sentinel lymph node mapping and routine pelvic lymph node detection in endometrial cancer in clinical stage I-II.

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sentinel lymph node mapping

The group composed of patients who undergo sentinel lymph node mapping

Group Type EXPERIMENTAL

Sentinel lymph node mapping

Intervention Type PROCEDURE

Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock.

3\. Sentinel lymph node is excised

Routine lymph node dissection

The group composed of patients who undergo routine pelvic lymph node dissection

Group Type ACTIVE_COMPARATOR

Routine lymph node dissection

Intervention Type PROCEDURE

1. Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy
2. Lymph node detection is performed.

Interventions

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Sentinel lymph node mapping

Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock.

3\. Sentinel lymph node is excised

Intervention Type PROCEDURE

Routine lymph node dissection

1. Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy
2. Lymph node detection is performed.

Intervention Type PROCEDURE

Other Intervention Names

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Indocyanine green Fluorescent camera

Eligibility Criteria

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Inclusion Criteria

1. 20 \~ 80 years old female
2. histologically diagnosed endometrial cancer that has never been treated before.
3. histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type
4. histological grade : FIGO grade 1, 2, 3
5. Presumed FIGO stage I-II
6. Planed for laparoscopic or robotic hystererctomy and lymph adenectomy
7. Largest pelvic or para-aortic lymph node diameter = or \< 15 mm in short axis on MRI
8. ECOG performance status 0-2
9. ASA PS 0-2
10. WBC ≥ 3,000/mm3, Platelets ≥ 100,000/mm3, Creatinine ≤ 2.0 mg/dL ,Bilirubin ≤ 1.5 x institutional upper limit normal ,SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal
11. A patient who voluntarily signed a document for the study.

Exclusion Criteria

1. Presumed FIGO stage III-IV
2. Neuroendocrine tumor histology
3. Other disease involving lymphatic system
4. lymphedema of the lower extremity or inguinal area
5. previous pelvic or paraaortic lymph node dissection
6. previous radiation or concurrent chemoradiation therapy of abdomen or pelvis
7. previous chemotherapy due to malignant disease of abdomen or pelvis
8. Patients who have had or have been treated for cancer within five years, other than non-melanoma skin cancer, carcinoma in situ of uterine cervix, stomach or bladder
9. severe, uncontrolled underlying diseases or underlying disease with complications
10. hypersensitivity to indocyanine green
11. a pregnant or breast-feeding woman

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No