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

Sponsor
Ankara University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02822833
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
11
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sentinel lymph node mapping
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sentinel lymph node mapping

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

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.
Other Names:
  • Karl Storz ICG system, to visualize the fluorescence
  • Indocyanine green, PULSION medical systems

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity and specificity of sentinel lymph node frozen section [6 months]

    2. Unilateral or bilateral sentinel lymph node detection rate by indocyanine green [6 months]

    Secondary Outcome Measures

    1. Negative and positive predictive values for sentinel lymph node frozen section [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ankara University School of Medicine Department of Ob&Gyn Ankara Turkey

    Sponsors and Collaborators

    • Ankara University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    salih taskin, Assoc. Prof., Ankara University
    ClinicalTrials.gov Identifier:
    NCT02822833
    Other Study ID Numbers:
    • 04
    First Posted:
    Jul 4, 2016
    Last Update Posted:
    Sep 13, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Sep 13, 2016