Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer (SLN-EC-01)

Shandong University

Status: Enrolling

Conditions: Endometrial Cancer

Treatments: Procedure: injecting indocyanine green (ICG) dye Intraoperative

Study type: Interventional

Funder types: Other

Identifiers

NCT06656949

KYLL-202404-005-1

Details and patient eligibility

About

The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. The aim of this study is to investigate whether the detection rate of sentinel lymph node (SLN) with two different injection sites may be increased compared to the standard use with single site (cervix) injection in endometrial cancer.

Full description

The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed if sentinel lymph node is positive.

Enrollment: 42 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • 1.Age >18 and <80 years old

  • 2. The pathological diagnosis was epithelial ovarian cancer
  • 3.Survival time is expected to exceed 3 months
  • 4.Signed consent form

Exclusion criteria

• 1. Patients with myocardial infarction or stroke, or unstable angina pectoris or decompensated heart function
• 2.Patients with a history of exhaustion or deep vein thrombosis;
• 3. Liver insufficiency (transaminase >2.5 times the upper limit of the standard);
• 4. Renal insufficiency (serum muscle liver >2 times the standard upper limit);
• 5. Pregnancy and perinatal patients;
• 6. History of major organ transplantation and immune disease;
• 7. Psychiatric condition or language barriers
• 8. Alcohol or drug abuser (current or previous)
• 9. Unable or unwilling to sign informed consent or comply with study requirements;
• 10. Patients with other malignant tumors.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

sentinel lymph node mapping with One injection site (cervix) group

Active Comparator group

Description:

injecting indocyanine green (ICG) dye Intraoperative in cervix

Treatment:

Procedure: injecting indocyanine green (ICG) dye Intraoperative

sentinel lymph node mapping with two injection site (cervix-uterus) group

Experimental group

Description:

injecting indocyanine green (ICG) dye Intraoperative in cervix and uterus

Treatment:

Procedure: injecting indocyanine green (ICG) dye Intraoperative