Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- 4.5 year disease-free survival [DFS] rate
研究概览
简要总结
The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.
详细描述
Cervical cancer is the 4th most common gynecologic cancer and treatment in early stages consists of surgery, chemotherapy, or radiation therapy. Surgical methods are simple or radical hysterectomy and pelvic and para-aortic lymph node dissection either done in an open manner or minimally invasive surgery (robotic or laparoscopic). However, a phase III cinical trial in 2018 comparing the safety and efficacy between minimally invasive surgery and open surgery in performing radical hysterectomy, 'Laparoscopic Approach to Cervical Cancer' (LACC), showed that open surgery is safer than minimally invasive surgery. Possible causes of such results are as follows:
- Carbon dioxide is supplied during laparoscopic operations to maintain capnoperitoneum, which can cause the implantation and proliferation of tumor cells exposed to the peritoneal cavity.
- Insertions of uterine manipulators into the endometrial cavity is commonly done, which can cause tumor cells to travel to both salpinges.
- Tumor cells can be exposed to the peritoneal cavity when the cervix is exposed during intracorporeal colpotomy.
- Tumor cells exposed to the peritoneal cavity can travel upwards when the patient's position is maintained in the Trendelenburg position during minimally invasive operations, leading to distant metastasis.
Based on the above-mentioned hypothesis, the following methods could be applied to minimize the exposure of tumor cells to the peritoneal cavity.
- The application of a vaginal tube instead of a uterine manipulator to prevent tumor cells from traveling to the salpinges.
- The ligation of both salpinges prior to insertion of a vaginal tube to block the travel of tumor cells.
- The performance of extracorporeal colpotomy instead to prevent the exposure of tumor cells inside the peritoneal cavity.
Although it would be favorable to perform all the forementioned methods, extracorporeal colpotomy is difficult to perform especially in menopausal patients with atrophic vaginitis or patients with no sexual experience. Thus, an alternative method is to use an endoscopic stapler which can simultaneously cut and suture the cervix into a vaginal stump, which can prevent tumor cells from being exposed to the peritoneal cavity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All patients enrolled in this clinical trial will undergo radical hysterectomy through minimally invasive surgery using an endoscopic stapler which both cuts and simultaneously sutures the open vaginal stump.
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
- •Females, aged 20 years or older
- •Histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
- •Patients with FIGO stage IB1 (FIGO staging 2009)
- •: stromal invasion>5 mm or 7 mm <lesion size ≤4 cm
- •Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)
- •Patients with normal bone marrow, renal and hepatic function
- •WBC > 3.0x10^9 cells/L
- •Platelets > 100x10^9 cells/L
- •Serum creatinine ≤1.5 mg/dL
- •Serum total bilirubin <1.5 x normal range and AST/SGOT or ALT/SGPT <3 x normal range
- •ECOG performance status 0 or 1
- •Synchronous cancer with no evidence of recurrence during the past 5 years
- •Informed consent of patient
排除标准
- •Any histological type other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
- •Tumor size greater than 4 cm
- •Patients with FIGO less than stage IA2 or greater than IB2 (FIGO staging 2009)
- •stromal invasion ≤5 mm and lesion size ≤7 mm (less than IA2)
- •or lesion size> 4 cm (greater than IB2)
- •Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes greater than 2 cm, or histologically positive lymph nodes
- •Patients in pregnancy
- •Patients with a history of pelvic or abdominal radiotherapy
- •Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator)
- •Patients who agree to intra-operative lymphatic mapping (IOLM) must not have:
- •Known allergies to triphenylmethane compounds
- •History of retroperitoneal surgery.
- •History of pelvic irradiation.
- •Cold knife or LEEP cone biopsy within 4 weeks of enrollment
结局指标
主要结局
4.5 year disease-free survival [DFS] rate
时间窗: Examined at post-operative 4.5 years
Probability of no recurrence from the day of surgery until post-operative 4.5 years
次要结局
- 4.5 year overall survival [OS] rate(Examined at post-operative 4.5 years)
- Pattern of recurrence sites(Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years)
- Morbidity(Examined during operation and post-operative 4 and 6 weeks.)
研究者
Hee Seung Kim
Associate Professor
Seoul National University Hospital