Study on Intraoperative Sentinel Lymph Node Diagnosis in Robot-Assisted Surgery for Endometrial Cancer

Recruiting

• Conditions: endometrial cancer

• Registration Number: jRCTs061250016

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-14
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Patients who meet all of the following criteria will be included

1. Patients undergoing robot-assisted malignant uterine tumor surgery for clinically stage IA endometrial cancer.
2. Patients with histological types of endometrioid adenocarcinoma G1 or G2.
3. Patients without pathological lymph node enlargement as assessed by preoperative pelvic MRI and chest-to-pelvic CT.
4. Patients aged 18 years or older at the time of obtaining consent.
5. Patients with an ECOG Performance status, PS) of 0 or 1.
6. patients with no prior history of radiation or chemotherapy for uterine cancer.
7. patients with preserved cardiac, hepatic, renal, and pulmonary function.
8. Patients who have provided written informed consent.

Exclusion Criteria

1. Patients with a history of hypersensitivity to indocyanine green (ICG).
2. Patients with a history of iodine hypersensitivity.
3. Patients with psychiatric disorders or symptoms that may make participation in the study difficult.
4. Patients deemed unsuitable by the principal investigator or co-investigators.

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Negative predictive value of sentinel lymph node biopsy		The negative predictive value of sentinel lymph node (SN) biopsy identified using the combined method will be assessed using permanent tissue specimens.
Histopathological evaluation of lymph nodes		The sentinel lymph nodes and other pelvic lymph nodes will be evaluated through permanent histopathological examination.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of SN biopsy		Sensitivity of SN biopsy identified by the combined method based on permanent tissue specimens.
Incidence of postoperative complications		The incidence of postoperative complications potentially influenced by pelvic lymphadenectomy (e.g., lower limb lymphedema, lymphocyst formation, ileus, and others).
Frequency of intraoperative factors		The frequency of intraoperative factors, including operative time, intraoperative blood loss, need for transfusion, and presence of nerve injury.
Concordance rate between intraoperative frozen section diagnosis and permanent histopathological diagnosis		The concordance rate between intraoperative frozen section diagnosis and permanent histopathological diagnosis of SN biopsy.
SN detection rate		The SN detection rate (agreement rate of the ICG dye method compared to the RI method).