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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Ankara University

Current Primary Outcome:

  • Sensitivity and specificity of sentinel lymph node frozen section [ Time Frame: 6 months ]
  • Unilateral or bilateral sentinel lymph node detection rate by indocyanine green [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Negative and positive predictive values for sentinel lymph node frozen section [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Ankara University

Dates:
Date Received: June 24, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: September 11, 2016
Last Verified: September 2016