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Clinical Trials/NCT02822833
NCT02822833UnknownNot Applicable

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

Ankara University1 site in 1 country100 target enrollmentStarted: July 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Unilateral or bilateral sentinel lymph node detection rate by indocyanine green

Time Frame: 6 months

Sensitivity and specificity of sentinel lymph node frozen section

Time Frame: 6 months

Secondary Outcomes

  • Negative and positive predictive values for sentinel lymph node frozen section(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

salih taskin

Assoc. Prof.

Ankara University

Study Sites (1)

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