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Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
RECRUITINGN/ASponsored by Asan Medical Center
Actively Recruiting
PhaseN/A
SponsorAsan Medical Center
Started2022-01-26
Est. completion2027-12-01
Eligibility
Age20 Years – 80 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04845828
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
Age: 20 Years – 80 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria: 1. 20 \~ 80 years old female 2. histologically diagnosed endometrial cancer that has never been treated before. 3. histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type 4. histological grade : FIGO grade 1, 2, 3 5. Presumed FIGO stage I-II 6. Planed for laparoscopic or robotic hystererctomy and lymph adenectomy 7. Largest pelvic or para-aortic lymph node diameter = or \< 15 mm in short axis on MRI 8. ECOG performance status 0-2 9. ASA PS 0-2 10. 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 11. A patient who voluntarily signed a document for the study. Exclusion Criteria: 1. Presumed FIGO stage III-IV 2. Neuroendocrine tumor histology 3. Other disease involving lymphatic system 4. lymphedema of the lower extremity or inguinal area 5. previous pelvic or paraaortic lymph node dissection 6. previous radiation or concurrent chemoradiation therapy of abdomen or pelvis 7. previous chemotherapy due to malignant disease of abdomen or pelvis 8. Patients who have had or have been treated for cancer within five years, other than non-melanoma skin cancer, carcinoma in situ of uterine cervix, stomach or bladder 9. severe, uncontrolled underlying diseases or underlying disease with complications 10. hypersensitivity to indocyanine green 11. a pregnant or breast-feeding woman
Conditions2
CancerEndometrial Cancer
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Actively Recruiting
PhaseN/A
SponsorAsan Medical Center
Started2022-01-26
Est. completion2027-12-01
Eligibility
Age20 Years – 80 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04845828