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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-08-30

Brief Summary

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to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy

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Detailed Description

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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.

Conditions

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Endometrial Cancer Sentinel Lymph Node Indocyanine Green

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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assesment SLND with enjection by using ICG

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.

Indocyanine green solution

Intervention Type DRUG

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.

assesment SLND with hysterescopy by using ICG

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.

Indocyanine green solution

Intervention Type DRUG

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.

Interventions

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Indocyanine green solution

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.

Intervention Type DRUG

Other Intervention Names

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No indocyanine green solution

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No