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

Haseki Training and Research Hospital

Status: Unknown

Conditions: Endometrial Cancer; Sentinel Lymph Node; Indocyanine Green

Treatments: Drug: Indocyanine green solution

Study type: Observational

Funder types: Other

Identifiers

NCT04514289

20-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

106 participants in 2 patient groups

assesment SLND with enjection by using ICG

Description:

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.

Treatment:

Drug: Indocyanine green solution

assesment SLND with hysterescopy by using ICG

Description:

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.

Treatment:

Drug: Indocyanine green solution