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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04514289
• Other study ID #: 20-2020
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: August 2020
• Source: Haseki Training and Research Hospital
• Contact: Cihan Comba, M.D.
• Phone: +90505 473 53 63
• Email: comba.cihan[@]yahoo.com.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: August 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Indocyanine Green
• Sentinel Lymph Node

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Turkey	Cihan Comba	Istanbul	Sultangazi

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SLN detecting rate	SLN is the first lymph node to spread tumoral cells.	1 year
Secondary	Overall survival	Overall survival of endometrial cancer measures as five years	5 years
Secondary	Disease free survival	Disease free survival can be describe with no tumor occurance after surgery	5 years