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

Endometrial Neoplasm Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02822833
• Other study ID #: 04
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2016
• Last updated: September 11, 2016
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Ankara University
• Contact: Salih Taskin, Assoc. Prof.
• Phone: +903125956405
• Email: salihtaskin[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Endometrial Neoplasm
• Endometrial Neoplasms

Intervention

Procedure:
• Sentinel lymph node mapping
Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix. Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.

Locations

Country	Name	City	State
Turkey	Ankara University School of Medicine Department of Ob&Gyn	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of sentinel lymph node frozen section		6 months	No
Primary	Unilateral or bilateral sentinel lymph node detection rate by indocyanine green		6 months	No
Secondary	Negative and positive predictive values for sentinel lymph node frozen section		6 months	No