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

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.

This study exclusively includes patients with stage IB2 or IIA1 cervical cancer who have tumors measuring 2 cm or larger but less than 4 cm. After randomization, one group undergoes radical hysterectomy via open surgery, while the other group undergoes minimally invasive radical hysterectomy using an endoscopic stapler. This approach using an endoscopic stapler aims to prevent intraoperative exposure of tumor cells to the abdominal cavity, comparable to open surgery, thereby enabling a comparison of therapeutic efficacy and safety.

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