NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	endometrial cancer
Date of first enrollment	06/06/2025
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	This study involves the identification of sentinel lymph nodes in endometrial cancer, a procedure that has not yet been covered by insurance in Japan.

Outcome(s)

Primary Outcome

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

Secondary Outcome

1) Sensitivity of SN biopsy identified by the combined method based on permanent tissue specimens. 2) The incidence of postoperative complications potentially influenced by pelvic lymphadenectomy (e.g., lower limb lymphedema, lymphocyst formation, ileus, and others). 3) The frequency of intraoperative factors, including operative time, intraoperative blood loss, need for transfusion, and presence of nerve injury. 4) The concordance rate between intraoperative frozen section diagnosis and permanent histopathological diagnosis of SN biopsy. 5) The SN detection rate (agreement rate of the ICG dye method compared to the RI method).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include 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.
Exclude 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.