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Randomized Comparison Between Sentinel Lymph Node Biopsy and Lymph Node Dissection in Early Stage Endometrial Cancer

NCT04845828 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2022-02-21

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Sentinel 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

PROCEDURE

Routine lymph node dissection

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2027-12-01
Completion
2029-12-01

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04845828 on ClinicalTrials.gov