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一项针对胃癌患者的腹腔镜辅助远端胃切除术联合D2淋巴结清扫术的II期临床试验。

A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients.

作者信息

Lee Jun Ho, Kim Young-Woo, Ryu Keun Won, Lee Jong Ryul, Kim Chan Gyoo, Choi Il Ju, Kook Myoung Cheorl, Nam Byung-Ho, Bae Jae-Moon

机构信息

Center for Gastric Cancer, National Cancer Center, 809 Madu-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, 411-769, Korea.

出版信息

Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.

Abstract

OBJECTIVES

This study was conducted to determine whether laparoscopy-assisted distal gastrectomy (LADG) with complete D2 lymph node dissection for gastric cancer is a safe and effective surgical option.

METHODS

During an 8-month period, 64 patients, who were diagnosed preoperatively as having T1-2, N0-1 or M0 gastric cancer, were prospectively enrolled to undergo LADG with D2 lymph node dissection; two surgeons with experience of over 50 cases of laparoscopic gastrectomy performed the procedures. The compliance rate, defined as cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping, for the open gastrectomy with D2 lymph node dissection was 66.0% in a pilot study and was used for calculations of sample size. Compliance rate and other surgical outcomes, including the number of retrieved lymph nodes from each lymph node station, morbidities, mortalities and conversion rate, were analyzed.

RESULTS

The compliance rate was 67.2% and was similar to that of open distal gastrectomy reported in the pilot study. The mean number of retrieved lymph nodes was 50.1 (range 20-100). The most frequently missed lymph node station was no. 5 (31.2%) followed by no. 3 (25.0%). There were no missed lymph nodes at stations no. 6 and 9. The complication rate was 3.1% (2/66); there were two conversions (3.0%) and no mortalities.

CONCLUSIONS

The current study suggests that LADG with D2 lymph node dissection is oncologically feasible, and phase-III clinical trials will be needed.

摘要

目的

本研究旨在确定腹腔镜辅助远端胃癌根治术(LADG)联合完整D2淋巴结清扫术治疗胃癌是否是一种安全有效的手术选择。

方法

在8个月的时间里,前瞻性纳入64例术前诊断为T1-2、N0-1或M0期胃癌的患者,接受LADG联合D2淋巴结清扫术;由两位具有50多例腹腔镜胃切除术经验的外科医生实施手术。在一项前期研究中,按照日本胃癌研究学会(JRSGC)淋巴结分组标准,D2淋巴结清扫开放胃切除术的符合率(定义为淋巴结清扫站数不超过一处缺失的病例)为66.0%,并用于样本量计算。分析符合率及其他手术结果,包括各淋巴结清扫站的淋巴结回收数量、发病率、死亡率和中转率。

结果

符合率为67.2%,与前期研究报告的开放远端胃切除术的符合率相似。回收淋巴结的平均数量为50.1个(范围20-100个)。最常遗漏的淋巴结站是第5站(31.2%),其次是第3站(25.0%)。第6站和第9站没有遗漏淋巴结。并发症发生率为3.1%(2/66);有2例中转(3.0%),无死亡病例。

结论

本研究表明,LADG联合D2淋巴结清扫术在肿瘤学上是可行的,需要进行III期临床试验。

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