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

A

Ankara University

Status

Unknown

Conditions

Endometrial Neoplasm

Treatments

Procedure: Sentinel lymph node mapping

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Sentinel lymph node mapping
Experimental group
Description:
Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically
Treatment:
Procedure: Sentinel lymph node mapping

Trial contacts and locations

1

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Central trial contact

Salih Taşkın, Assoc. Prof.

Data sourced from clinicaltrials.gov

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