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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04514289
Enrollment
106
Registered
2020-08-14
Start date
2020-03-01
Completion date
2021-08-30
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Sentinel Lymph Node, Indocyanine Green

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.

Interventions

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.

Sponsors

Haseki Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
SLN detecting rate1 yearSLN is the first lymph node to spread tumoral cells.

Secondary

MeasureTime frameDescription
Overall survival5 yearsOverall survival of endometrial cancer measures as five years
Disease free survival5 yearsDisease free survival can be describe with no tumor occurance after surgery

Countries

Turkey (Türkiye)

Contacts

Primary ContactCihan Comba, M.D.
comba.cihan@yahoo.com.tr+90505 473 53 63
Backup ContactBusra Atas, M.D.
bussraseker@hotmail.com+905347119889

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026