To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy

Detailed Description
-----------------
Endometrial cancer is the most common gynecologic cancer. Most patients diagnosed in early stages because cancer causes remarkable symptoms such as postmenopausal or abnormal bleeding. Mostly, it does not spread, detects no metastasis. Endometrial carcinoma is surgically staged. Laparotomy or minimally invasive surgery can be performed for treatment and staging. Patients have been operated for staging surgery, have a larger surgical incision, longer operation period, more complications, more intensive care units need. Nowadays, researchers show us that there is no difference in overall survival and prognosis between surgery with or without lymphadenectomy in endometrial cancer. With all these improvements in gynecologic oncology leads us to minimally invasive surgery. Patients undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The first group who the cervix is injected superficially with 1 mL of ICG ( indocyanine green) at 4 and 8 o'clock quadrans. The second group who ICG has injected the uterine cavity during hysteroscopy. The investigator's aim is to assess and compare the performance of two approaches for sentinel lymph node ( SLND) biopsy.

Official Title
-----------------
Endometrium Kanseri Nedeniyle Opere Olacak hastaların Sentinel Lenf Nodu Diseksiyonu değerlendirilirken kullanılan Iki farklı yöntemin kıyaslaması

Conditions
-----------------
Endometrial Cancer, Sentinel Lymph Node, Indocyanine Green

Intervention / Treatment
-----------------
* Drug: Indocyanine green solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must be willing and able to provide informed consent The patient is willing and able to comply with the study protocol The patient has endometrial cancer and is performed SLND The patient agrees to follow-up examination out to 5-years post-treatment Exclusion Criteria: The patient is not a candidate for surgery The patient has metastasis The patient has known or suspected allergies to iodine, indocyanine green( ICG)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| assesment SLND with enjection by using ICG<br>Patients who have endometrium cancer; undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The first group in which the cervix is injected superficially with 1 mL of ICG ( indocyanine green) at 4 and 8 o'clock quadrans. | Drug: Indocyanine green solution<br>* Indocyanine green (ICG) is a cyanine dye used in medical diagnostics.ICG is a fluorescent dye that is used in medicine as an indicator substance.<br>* Other names: No indocyanine green solution;|
| assesment SLND with hysterescopy by using ICG<br>Patients who have endometrium cancer; undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The second one which ICG has injected the uterine cavity during hysteroscopy. Our aim is to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy. | Drug: Indocyanine green solution<br>* Indocyanine green (ICG) is a cyanine dye used in medical diagnostics.ICG is a fluorescent dye that is used in medicine as an indicator substance.<br>* Other names: No indocyanine green solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SLN detecting rate | SLN is the first lymph node to spread tumoral cells. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival of endometrial cancer measures as five years | 5 years | 
| Disease free survival | Disease free survival can be describe with no tumor occurance after surgery | 5 years |