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

NCT04514289 — Unknown, 106 participants, Haseki Training and Research Hospital

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

RegistryNCT04514289
StatusUnknown
Study typeObservational
Enrollment106 (Estimated)
SponsorHaseki Training and Research Hospital (Other)
ConditionsEndometrial Cancer, Sentinel Lymph Node, Indocyanine Green
InterventionsIndocyanine green solution (Drug)
Datesstart 2020-03-01, primary completion 2021-06-30 (estimated), completion 2021-08-30 (estimated), first posted 2020-08-14, last updated 2020-08-14
Locations1 site in Turkey (Türkiye)

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-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
assesment SLND with enjection by using ICGDrug: Indocyanine green solutionPatients 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 ICGDrug: Indocyanine green solutionPatients 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 (Drug), also known as No 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.

+Outcome measures

Primary outcomes

  • SLN detecting rate [1 year]: SLN is the first lymph node to spread tumoral cells.

Secondary outcomes

  • 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

+Eligibility

Sex: Female, ages: 18 Years to 90 Years

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)

+Locations (1)

FacilityCityCountryStatus
Cihan CombaIstanbul, SultangaziTurkey (Türkiye)Recruiting

+Investigators

My Notes