NCT07256977Not yet recruiting
Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer
A Multicenter Non-inferiority Randomized Controlled Trial on Minimally Invasive Radical Hysterectomy Using an Endoscopic Stapler to Prevent Tumor Spillage in Stage IB2-IIA1 Cervical Cancer
Source: ClinicalTrials.gov · Last updated 2 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 494 (estimated)
- First submitted
- 6 Oct 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2034
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT07256977
What you commit to
- Study type: Interventional
- Planned participants: 494
- From 1 Jan 2026 to the primary completion date, 31 Dec 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Criteria:
- 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and \<4 cm)
- Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Planned for Type B or C radical hysterectomy
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
- Signed and approved consent form
- Exclusion Criteria:
- Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
- 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
- Prior pelvic or abdominal radiotherapy
- Prior neoadjuvant chemotherapy before surgery
- Unsuitable for surgery due to severe systemic disease at the investigator's discretion
- 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
Age in the registry: 20 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.