Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer

Not Applicable

Recruiting

• Conditions: Endometrial Cancer

• Registration Number: NCT06656949
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24
• Study Start: 2024-10-30
• Primary Completion: 2025-10-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
paraaortic Sentinel lymph node detection rates	intraoperative day0	IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
Sentinel lymph node technique accuracy	postoperative up to day7	Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis

Secondary Outcome Measures

Name	Time	Method
Optimizing Sentinel lymph node detection procedure in endometrium cancer	intraoperative day 0	Optimizing injectiong site, tow site injection vs one site injection
The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site	intraoperative day 0	assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site
Postoperative complications	postoperative up to day 30	Postoperative complications including damage of insestine , urethra and bladder

Trial Locations

Locations (1)

Qilu Hospital，Shandong University; 🇨🇳 Jinan, Shandong, China