Safety Of Laparoscopic or robotic radical hysterectomy Using endoscopic sTapler for Inhibiting tumOr spillage of cervical Neoplasms (SOLUTION): a phase II study

Seoul National University Hospital0 个研究点目标入组 124 人开始时间: 待定最近更新: 2020年6月15日

适应症

试验速览

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•? 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

•? 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

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