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Starting soon Not applicable

Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer

NCT07256977 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2025-12-02

Condition(s) studied

Cervical Cancer Stage IB2Cervical Cancer Stage IIa

Investigational drug(s) / intervention(s)

Open radical hysterectomyMinimally invasive radical hysterectomy

Open radical hysterectomy: Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy

Minimally invasive radical hysterectomy: Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy

Study summary

This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
No
I. Inclusion Criteria: 1. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and \<4 cm) 2. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 3. Planned for Type B or C radical hysterectomy 4. With adequate bone marrow, renal, and hepatic function * WBC \>3.0 × 10⁹ cells/L * Platelets \>100 × 10⁹ cells/L * Creatinine \<180 μmol/L * Bilirubin \<1.5 × normal range * AST, ALT \< 3 × normal range 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years 7. Signed and approved consent form II. Exclusion Criteria: 1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 2. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease 3. The following are observed on preoperative CT or MRI * Tumor size ≥4 cm * Lymph node metastasis (short axis ≥15 mm) * Paracervical invasion * Bladder or rectal invasion * Distant metastasis 4. Prior pelvic or abdominal radiotherapy 5. Prior neoadjuvant chemotherapy before surgery 6. Unsuitable for surgery due to severe systemic disease at the investigator's discretion 7. Difficult to consider intraoperative lymphatic mapping due to * Allergy to triphenylmethane compounds * History of prior retroperitoneal surgery * History of prior pelvic radiotherapy * Cases where cold knife or loop electrosurgical excision procedure (LEEP) was performed within 4 weeks prior to study participation * Allergy to triphenylmethane compounds

Primary outcome measure(s)

  • 4.5-year progression-free survival rate — Up to 4.5 years after enrollment
    Proportion of patients alive without disease progression or death at 4.5 years after enrollment, as assessed by radiographic imaging and/or clinical criteria

Trial sites (1)

FacilityCityRegionStatus
Seoul National University College of Medicine Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07256977 on ClinicalTrials.gov ↗ ← All trials in South Korea