Clinical trial · Interventional
Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer
Prospective Randomized Comparison of Sentinel Lymph Node Mapping Using Indocyanine Green and Conventional Pelvic Lymph Node Dissection in Clinical Stage I-II Endometrial Cancer
NCT04845828CI-TRIAL-00056646SELYErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine lymph node dissection | Procedure | — | UNRESOLVED |
| Sentinel lymph node mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sentinel lymph node mapping
- description
- The group composed of patients who undergo sentinel lymph node mapping
- interventionNames
- Procedure: Sentinel lymph node mapping
- type
- ACTIVE_COMPARATOR
- label
- Routine lymph node dissection
- description
- The group composed of patients who undergo routine pelvic lymph node dissection
- interventionNames
- Procedure: Routine lymph node dissection
Primary outcomes (1)
- measure
- The 3-year disease-free survival (3-year DFS)
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDLecuru F, Mathevet P, Querleu D, Leblanc E, Morice P, Darai E, Marret H, Magaud L, Gillaizeau F, Chatellier G, Dargent D. Bilateral negative sentinel nodes accurately predict absence of lymph node metastasis in early cervical cancer: results of the SENTICOL study. J Clin Oncol. 2011 May 1;29(13):1686-91. doi: 10.1200/JCO.2010.32.0432. Epub 2011 Mar 28. PMID 21444878
- BACKGROUNDBallester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12. PMID 21489874
- BACKGROUNDBae HS, Lim MC, Lee JS, Lee Y, Nam BH, Seo SS, Kang S, Chung SH, Kim JY, Park SY. Postoperative Lower Extremity Edema in Patients with Primary Endometrial Cancer. Ann Surg Oncol. 2016 Jan;23(1):186-95. doi: 10.1245/s10434-015-4613-1. Epub 2015 May 19. PMID 25986870
- BACKGROUNDTanner EJ, Sinno AK, Stone RL, Levinson KL, Long KC, Fader AN. Factors associated with successful bilateral sentinel lymph node mapping in endometrial cancer. Gynecol Oncol. 2015 Sep;138(3):542-7. doi: 10.1016/j.ygyno.2015.06.024. Epub 2015 Jun 19. PMID 26095896
- DERIVEDPark JY, Kim JH, Baek MH, Park E, Kim SW. Randomized comparison between sentinel lymph node mapping using indocyanine green plus a fluorescent camera versus lymph node dissection in clinical stage I-II endometrial cancer: a Korean Gynecologic Oncology Group trial (KGOG2029/SELYE). J Gynecol Oncol. 2022 Nov;33(6):e73. doi: 10.3802/jgo.2022.33.e73. Epub 2022 Jul 25. PMID 36047376