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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 494
- 试验地点
- 1
- 主要终点
- 4.5-year progression-free survival rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •I. 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
排除标准
- •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
研究组 & 干预措施
Open radical hysterectomy
Radical hysterectomy is performed via open surgery
干预措施: Open radical hysterectomy (Device)
Minimally invasive radical hysterectomy
Radical hysterectomy is performed via minimally invasive surgery
干预措施: Minimally invasive radical hysterectomy (Device)
结局指标
主要结局
4.5-year progression-free survival rate
时间窗: 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
次要结局
- Intraoperative complcation rate(During surgery)
- Postoperative acute complication rate within 4 weeks(Within 4 weeks after surgery)
- Postoperative complication rate after 4 weeks(Greater than 4 weeks up to 12 months post-surgery)
- Operation time(Peri-procedural)
- Transfusion requirement(From the surgical incision to the end of surgery (skin closure))
- Estimated blood loss(Peri-procedural)
- The 12-item Short Form Health Survey (SF-12)(Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score can range from 0 to 100, with a higher score indicating less severe symptoms.)
- Pelvic Floor Distress Inventory (PFDI)(Assessed at Visit 1 (within 4 weeks), Visit 5 (3 months), Visit 6 (6 months), Visit 10 (18 months), Visit 13 (30 months), Visit 15 (42 months), Visit 17 (54 months). The score can range from 0 to 300, with a higher score indicating more severe symptoms.)
- Length of hospitalization(From date of hospital admission to date of hospital discharge, assessed up to 30 days.)
- Postoperative pain(Assessed at each visit from Visit 2 (2 weeks) and Visit 17 (54 months). The score can range from 0 to 10, with a higher score indicating more severe pain.)
- Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)(Assessed at Visit 1(within 4 weeks), Visit 3(2 weeks), Visit 4(6 weeks), Visit 5(3 months), Visit 6(6 months), Visit 10(18 months), Visit 13(30 months), Visit 17(54 months).)
- EQ-5D-5L(Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score ranges from -0.594 to 1.000, showing that higher scores mean healthier.)
- 4.5-year overall survival rate(Up to 4.5 years after surgery)
- Recurrence pattern at first recurrence(From date of surgery through 4.5 years postoperatively)
研究者
Hee Seung Kim
Clinical Professor
Seoul National University Hospital