The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

Not Applicable

• Conditions: Endometrial Neoplasm
• Interventions: Procedure: Sentinel lymph node mapping

• Registration Number: NCT02822833
• Lead Sponsor: Ankara University

Brief Summary

Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. 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. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-24
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-11
• Last Update Posted: 2016-09-13
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Pathologic diagnosis of endometrial cancer
• Clinical stage I or II

Exclusion Criteria

• Contraindications for operation (hematological or coagulation disorders)
• Advanced stage
• Pregnancy or puerperium
• Fertility preserving surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel lymph node mapping	Sentinel lymph node mapping	Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically

Primary Outcome Measures

Name	Time	Method
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green	6 months
Sensitivity and specificity of sentinel lymph node frozen section	6 months

Secondary Outcome Measures

Name	Time	Method
Negative and positive predictive values for sentinel lymph node frozen section	6 months

Trial Locations

Locations (1)

Ankara University School of Medicine Department of Ob&Gyn; 🇹🇷 Ankara, Turkey