Radical vaginal trachelectomy (RVT) combined with laparoscopic pelvic lymphadenectomy:: Prospective multicenter study of 100 patients with early cervical cancer
Radical vaginal trachelectomy (RVT) combined with laparoscopic pelvic lymphadenectomy:: Prospective multicenter study of 100 patients with early cervical cancer
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DOI：
10.1016/j.ygyno.2006.03.040
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发表时间：
2006-11-01
影响因子：
4.7
通讯作者：
Schneider, Achim
中科院分区：
文献类型：
--
作者：
Hertel, Hermann;Koehler, Christhardt;Schneider, Achim
目标。德国妇科肿瘤学家协会(AGO)的这项名为“子宫6”的前瞻性临床多中心研究的目的是证明接受盆腔淋巴清扫术和根治性阴道沙眼切除术(RVT)的患者的复发率。我们还想证明RVT的手术安全性。自1995年3月至2005年11月，我们拟采用RVT治疗108例宫颈癌患者，其中TNM分期1A1期18例，1A2期21例，1B1期69例。8名患者被排除在外，因为RVT后不符合研究标准(肿瘤大小<2厘米、神经内分泌肿瘤类型、肿瘤累及切缘或盆腔淋巴结阳性)。因此，100例患者按方案接受了RVT治疗。在100例患者中有4次复发，计算出95%可信区间(包括连续性校正)的上限为10.5%。如果复发5次或5次以上，则必须停止招募。中位随访时间29个月(1-128个月)。100例接受RVT治疗的患者中有3例(3%)复发。因此，置信度上限为9.2%。预计5年无复发生存率和总生存率分别为97%和98%。手术时间115~402分钟，平均253分钟。围手术期并发症分别为：术后出血、髂外动脉栓塞症、腹膜后淋巴肿、麻痹性肠梗阻各1例。RVT联合腹腔镜盆腔及参数淋巴清扫术治疗早期宫颈癌
Objective. The aim of this prospective clinical multicenter study "Uterus 6" of the German Association of Gynecologic Oncologists (AGO) was to prove the recurrence rate of patients treated with pelvic lymphadenectomy and radical vaginal trachelectomy (RVT). We also wanted to prove the surgical safety of RVT.Methods. Between March 1995 and November 2005, we intend to treat 108 patients with cervical cancer (TNM stage 1A1, L1 n = 18, 1A2 n = 21, 1B1 n = 69) by RVT. Eight patients were excluded since the study criteria were not met after RVT (tumor size > 2 cm, neuroendocrine tumor type, tumor-involved resection margins, or positive pelvic lymph nodes). Thus, 100 patients were treated by RVT according to protocol. With 4 recurrences in a sample size of 100 patients, an upper limit of the 95% confidence interval (including continuity correction) of 10.5% was calculated. Recruitment had to be stopped if five or more recurrences occurred.Results. The median follow-up time was 29 (1-128) months. Three (3%) recurrences occurred in 100 patients treated with RVT according to protocol. Thus, the upper confidence limit was 9.2%. The projected 5-year recurrence-free and overall survival rates were 97% and 98%. The average duration of surgery was 253 (115-402) min. Perioperative complications were: postoperative bleeding, embolism of the external iliac artery, retroperitoneal lymphocele, or paralytic ileus in one patient, respectively.Conclusions. RVT combined with laparoscopic pelvic and parametric lymphadenectomy for treatment of patients with early stage cervical cancer