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比较经腹与腹膜外腹腔镜主动脉旁淋巴结切除术用于子宫内膜癌和卵巢癌手术分期的前瞻性随机试验:STELLA试验

Prospective Randomized Trial Comparing Transperitoneal Versus Extraperitoneal Laparoscopic Aortic Lymphadenectomy for Surgical Staging of Endometrial and Ovarian Cancer: The STELLA Trial.

作者信息

Díaz-Feijoo Berta, Correa-Paris Alejandro, Pérez-Benavente Assumpció, Franco-Camps Silvia, Sánchez-Iglesias José Luis, Cabrera Silvia, de la Torre Javier, Centeno Cristina, Puig Oriol Puig, Gil-Ibañez Blanca, Colas Eva, Magrina Javier, Gil-Moreno Antonio

机构信息

Unit of Gynecologic Oncology, Department of Obstetrics and Gynecology, Hospital Materno-infantil Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain.

Pathological Oncology Group and Pathology Department, Hospital Arnau de Vilanova, Lleida, Spain.

出版信息

Ann Surg Oncol. 2016 Sep;23(9):2966-74. doi: 10.1245/s10434-016-5229-9. Epub 2016 Apr 20.

DOI:10.1245/s10434-016-5229-9
PMID:27098143
Abstract

BACKGROUND

There is an ongoing debate on which approach, transperitoneal or extraperitoneal, is superior for the performance of laparoscopic aortic lymphadenectomy (LPA-LND) for the surgical staging of gynecologic cancer. A prospective randomized trial (STELLA trial) was designed to compare the perioperative outcomes and node retrieval of extraperitoneal versus transperitoneal aortic lymphadenectomy by laparoscopy or robot-assisted laparoscopy.

METHODS

Patients with endometrial or ovarian carcinoma requiring aortic lymphadenectomy for surgical staging were randomized to an extraperitoneal or transperitoneal approach by laparoscopy or robot-assisted laparoscopy between June 2012 and July 2014.

RESULTS

A total of 60 patients were entered into the study, 48 with endometrial cancer (80 %) and 12 with ovarian cancer (20 %). Thirty-one patients (51.6 %) were randomly assigned to the extraperitoneal group and 29 to the transperitoneal group (48.3 %). The means LPA-LND operating time was 90 min in both group (p = 0.343). The mean (range) blood loss was 105 (10-400) mL for extraperitoneal versus 100 (5-1000) mL for transperitoneal group (p = 0.541). There were no differences in the number of collected lymph nodes between the two groups [median (range) for extraperitoneal 12 (4-41) vs. 13 (4-29) for transperitoneal (p = 0.719)].

CONCLUSIONS

The extraperitoneal and transperitoneal approaches for laparoscopic and robotic aortic lymphadenectomy provide similar perioperative outcomes and nodal yields.

TRIAL REGISTRATION

The STELLA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT01810874.

摘要

背景

对于妇科癌症手术分期而言,腹腔镜主动脉淋巴结清扫术(LPA-LND)采用经腹还是腹膜外途径更具优势,目前仍存在争议。一项前瞻性随机试验(STELLA试验)旨在比较腹腔镜或机器人辅助腹腔镜下腹膜外与经腹主动脉淋巴结清扫术的围手术期结局及淋巴结获取情况。

方法

2012年6月至2014年7月期间,因手术分期需要进行主动脉淋巴结清扫术的子宫内膜癌或卵巢癌患者,被随机分配接受腹腔镜或机器人辅助腹腔镜下的腹膜外或经腹途径手术。

结果

共有60例患者纳入研究,其中48例为子宫内膜癌(80%),12例为卵巢癌(20%)。31例患者(51.6%)被随机分配至腹膜外组,29例被分配至经腹组(48.3%)。两组LPA-LND平均手术时间均为90分钟(p = 0.343)。腹膜外组平均(范围)失血量为105(10 - 400)毫升,经腹组为100(5 - 1000)毫升(p = 0.541)。两组收集的淋巴结数量无差异[腹膜外组中位数(范围)为12(4 - 41),经腹组为13(4 - 29)(p = 0.719)]。

结论

腹腔镜和机器人辅助主动脉淋巴结清扫术的腹膜外和经腹途径在围手术期结局及淋巴结获取量方面相似。

试验注册

STELLA试验已在美国国立卫生研究院(ClinicalTrials.gov)注册,注册号为#NCT01810874。

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