RecruitingNot ApplicableNCT04845828

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


Sponsor

Asan Medical Center

Enrollment

810 participants

Start Date

Jan 26, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to lymph node removal during surgery for early-stage uterine cancer — a full lymph node dissection versus a targeted technique (sentinel lymph node biopsy) that identifies only the first lymph nodes where cancer would likely spread — to see if the less invasive approach is just as effective. **You may be eligible if:** - You are a woman between 20 and 80 years old - You have been newly diagnosed with uterine (endometrial) cancer confirmed by biopsy - Your cancer is presumed to be early-stage (stage I or II) - You are scheduled for laparoscopic or robotic hysterectomy - Your lymph nodes appear normal or only mildly enlarged on MRI - Your overall health and blood counts are adequate **You may NOT be eligible if:** - Your cancer has spread beyond the uterus (presumed stage III–IV) - You have had prior radiation or chemotherapy to the pelvis or abdomen - You have lymphedema or prior lymph node surgery in the area - You are pregnant or breastfeeding - You have an allergy to indocyanine green (a dye used in surgery) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESentinel lymph node mapping

Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock. 3\. Sentinel lymph node is excised

PROCEDURERoutine lymph node dissection

1. Laparoscopic or robotic hysterectomy with/without bilateral salpingo-oophorectomy 2. Lymph node detection is performed.


Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT04845828


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