Therapeutic effect of minimally invasive staging surgery using cancer cell spillage minimizing techniques in the patients with early-stage endometrial cancer: A randomized prospective clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0010792

Enrollment

610

Registered

2025-07-21

Start date

2025-07-08

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 1. Experimental group: All 6 procedures are implemented. a. No use of uterine manipulator b. Vaginal washing c. Cervical occluison d. Peritoneal washing cytology after tubal ligati

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Women aged 20 years or older 2) Histologically diagnosed endometrial cancer that has not been previously treated 3) Histological type: endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type 4) Histological differentiation: FIGO grade 1, 2, 3 5) Predicted FIGO stage 1-2 6) Patients scheduled to undergo laparoscopic or robotic hysterectomy 7) Pelvic and para-aortic lymph node diameters less than 15 mm on MRI or CT 8) Patients with ECOG performance status 0-2 9) Patients with ASA PS 1-2 10) Patients with adequate organ function 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) Patients who voluntarily signed the informed consent form

Exclusion criteria

Exclusion criteria: The participating study subjects should not have any of the following exclusion criteria: 1) Predicted FIGO stage III-IV 2) Neuroendocrine tumor histology 3) Previous pelvic or para-aortic lymph node dissection 4) Patients with a history of radiation therapy to the abdominal or pelvic area 5) Patients with a history of chemotherapy for intra-abdominal or pelvic tumors 6) Patients with a history of cancer other than nonmelanoma skin cancer, cervical intraepithelial neoplasia, or superficial cancer of the stomach or bladder within the past 5 years or who have received cancer treatment 7) Patients with serious underlying diseases or complications 8) Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
3 year progression free survival rate	—

Secondary

Measure	Time frame
3 year overall survival rate;mordibity (complication);recurrent pattern	—

Countries

Korea, Republic of

Contacts

Public ContactEun-Ju Lee

Chung-Ang Univerisity Hospital

ejlee@cau.ac.kr+82-2-6299-3173

Outcome results