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

• Conditions: Endometrial Cancer; Indocyanine Green; Sentinel Lymph Node
• Interventions: Drug: Indocyanine green solution

• Registration Number: NCT04514289
• Lead Sponsor: Haseki Training and Research Hospital

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-07-29
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-13
• Last Update Submitted: 2020-08-13
• Study First Posted: 2020-08-14
• Last Update Posted: 2020-08-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 106

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
assesment SLND with enjection by using ICG	Indocyanine green solution	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.
assesment SLND with hysterescopy by using ICG	Indocyanine green solution	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.

Primary Outcome Measures

Name	Time	Method
SLN detecting rate	1 year	SLN is the first lymph node to spread tumoral cells.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	Overall survival of endometrial cancer measures as five years
Disease free survival	5 years	Disease free survival can be describe with no tumor occurance after surgery

Trial Locations

Locations (1)

Cihan Comba; 🇹🇷 Istanbul, Sultangazi, Turkey