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

Primary Purpose

Endometrial Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sentinel lymph node mapping
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Ankara University School of Medicine Department of Ob&GynRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sentinel lymph node mapping

Arm Description

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

Outcomes

Primary Outcome Measures

Sensitivity and specificity of sentinel lymph node frozen section
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green

Secondary Outcome Measures

Negative and positive predictive values for sentinel lymph node frozen section

Full Information

First Posted
June 24, 2016
Last Updated
September 11, 2016
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT02822833
Brief Title
The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sentinel lymph node mapping
Arm Type
Experimental
Arm Description
Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically
Intervention Type
Procedure
Intervention Name(s)
Sentinel lymph node mapping
Other Intervention Name(s)
Karl Storz ICG system, to visualize the fluorescence, Indocyanine green, PULSION medical systems
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of sentinel lymph node frozen section
Time Frame
6 months
Title
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Negative and positive predictive values for sentinel lymph node frozen section
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salih Taşkın, Assoc. Prof.
Phone
+903125956405
Email
salihtaskin@yahoo.com
Facility Information:
Facility Name
Ankara University School of Medicine Department of Ob&Gyn
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salih Taşkın, Assoc. Prof.
Phone
+903125956405
Email
salihtaskin@yahoo.com
First Name & Middle Initial & Last Name & Degree
Salih Taşkın, MD
First Name & Middle Initial & Last Name & Degree
Fırat Ortaç, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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