Brief Title
To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer
Official Title
Endometrium Kanseri Nedeniyle Opere Olacak hastaların Sentinel Lenf Nodu Diseksiyonu değerlendirilirken kullanılan Iki farklı yöntemin kıyaslaması
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 Type
Observational [Patient Registry]
Primary Outcome
SLN detecting rate
Secondary Outcome
Overall survival
Condition
Endometrial Cancer
Intervention
Indocyanine green solution
Study Arms / Comparison 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
106
Start Date
March 1, 2020
Completion Date
August 30, 2021
Primary Completion Date
June 30, 2021
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)
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Cihan Comba, M.D., +90505 473 53 63, [email protected]
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT04514289
Organization ID
20-2020
Responsible Party
Principal Investigator
Study Sponsor
Haseki Training and Research Hospital
Study Sponsor
Cihan Comba, M.D., Study Chair, Sultangazi Haseki Training and Research Hospital
Verification Date
August 2020