Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Through this clinical trial, the investigators aim to verify the usefulness and stability of sentinel lymph node mapping in endometrial cancer of clinical stage I-II.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
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⁃ 20 \

• 80 years old female

⁃ histologically diagnosed endometrial cancer that has never been treated before.

⁃ histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type

⁃ histological grade : FIGO grade 1, 2, 3

⁃ Presumed FIGO stage I-II

⁃ Planed for laparoscopic or robotic hystererctomy and lymph adenectomy

⁃ Largest pelvic or para-aortic lymph node diameter = or \< 15 mm in short axis on MRI

⁃ ECOG performance status 0-2

⁃ ASA PS 0-2

‣ WBC ≥ 3,000/mm3, Platelets ≥ 100,000/mm3, Creatinine ≤ 2.0 mg/dL ,Bilirubin ≤ 1.5 x institutional upper limit normal ,SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal

‣ A patient who voluntarily signed a document for the study.

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Jeong-Yeol Park, M.D Ph.D.,
obgyjypark@amc.seoul.kr
+82-2-3010-3646
Time Frame
Start Date: 2022-01-26
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 810
Treatments
Experimental: Sentinel lymph node mapping
The group composed of patients who undergo sentinel lymph node mapping
Active_comparator: Routine lymph node dissection
The group composed of patients who undergo routine pelvic lymph node dissection
Sponsors
Leads: Asan Medical Center

This content was sourced from clinicaltrials.gov