Laparoscopy-Assisted Versus Open Distal Gastrectomy for Early Gastric Cancer Evidence from Randomized and Nonrandomized Clinical Trials
Laparoscopy-Assisted Versus Open Distal Gastrectomy for Early Gastric Cancer Evidence from Randomized and Nonrandomized Clinical Trials
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DOI：
10.1097/sla.0b013e3182583e2e
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发表时间：
2012-07-01
影响因子：
9
通讯作者：
Cai, Ling
中科院分区：
文献类型：
--
作者：
Zeng, Yi-Ke;Yang, Zu-Li;Cai, Ling
目的：评估腹腔镜辅助远端胃切除术（LADG）在早期胃癌（EGC）患者中的安全性和有效性，以确定LADG是否是开腹远端胃切除术（ODG）的可接受替代方案。背景：LADG联合小于D2或D2淋巴结清扫术治疗早期胃癌，因其肿瘤学安全性和经济效益不确定，仍然是一种有争议的手术干预措施。我们进行了这项系统回顾和荟萃分析，其中包括 LADG 与 ODG 的随机对照试验 (RCT) 和非 RCT，以评估 LADG 对 EGC 患者的安全性和有效性是否与 ODG 相当。方法：对 PubMed、EMBASE、Cochrane 图书馆和中国知识资源综合数据库进行全面检索。该研究纳入了1994年1月1日至2010年12月31日期间发表的符合条件的试验。采用RevMan 5.0软件进行数据合成和统计分析。证据质量通过 GRADEpro 3.2.2 进行评估。结果：本研究纳入了 22 项研究，共 3411 名参与者。 LADG 中检索到的淋巴结平均数量与 ODG 中检索到的平均数量接近（在小于 D2 切除中：加权平均差 [WMD] = -1.79；95% 置信区间 [95% CI]，-5.78 至 2.19；P = 0.38；异质性：P < 0.00001，I-2 = 98%；在 D2 切除中：WMD = - 1.53；95% CI，-3.56 至 0.51；异质性：P = 0.23，I-2 = 26%）。 LADG 的总体术后发病率显着低于 ODG（相对风险 = 0.58；95% CI，0.46-0.74；P < 0.00001；异质性：P = 0.94，I-2 = 0%）。 LADG减少了术中失血量、术后镇痛药用量和住院时间，且不增加总住院费用和癌症复发率。接受 LADG 的患者的长期生存率与接受 ODG 的患者相似。然而，LADG 仍然是一个技术依赖型且耗时的过程。 LADG的转化率为0%至2.94%。报告的转换原因是出血、粘连和安全切除边缘要求。 局限性：本研究中的一些临床结果指标存在潜在偏差和显着异质性。对于这种新的手术干预措施，方法学上高质量的对照临床试验很少。根据建议评估、制定和评估方法的分级，通过与 EGC 患者的明确临床结局的 ODG 进行比较来评估 LADG 的安全性和有效性时，目前可用的临床证据的质量非常低。结论：当在经验丰富的手术中心进行 LADG 时，LADG 可能是 EGC 的技术上可行的替代方案，在这些中心进行 LADG 的患者可能会受益于更快的术后恢复。然而，目前可用的证据不能排除潜在的临床益处或危害，特别是在淋巴结阳性的病例中。进一步评估需要方法论上高质量的比较研究。
Objective: To evaluate the safety and efficacy of laparoscopy-assisted distal gastrectomy (LADG) in patients with early gastric cancer (EGC) to determine whether LADG is an acceptable alternative to open distal gastrectomy (ODG).Background: LADG combined with less than D2 or D2 lymphadenectomy for EGC is still a controversial surgical intervention for its uncertain oncological safety and economic benefit. We conducted this systematic review and meta-analysis that included randomized control trials (RCTs) and non-RCTs of LADG versus ODG to evaluate whether the safety and efficacy of LADG in patients with EGC are equivalent to those of ODG.Methods: A comprehensive search of PubMed, EMBASE, Cochrane Library, and China Knowledge Resource Integrated Database was performed. Eligible trials published between January 1, 1994, and December 31, 2010, were included in the study. Data synthesis and statistical analysis were carried out by RevMan 5.0 software. The quality of evidence was assessed by GRADEpro 3.2.2.Results: Twenty-two studies with 3411 participants were included in this study. The mean number of lymph nodes retrieved in LADG was close to that retrieved in ODG (in the less than D2 resection: weighted mean difference [WMD] = -1.79; 95% confidence interval [95% CI], -5.78 to 2.19; P = 0.38; heterogeneity: P < 0.00001, I-2 = 98%; and in the D2 resection: WMD = - 1.53; 95% CI, -3.56 to 0.51; P = 0.14; heterogeneity: P = 0.23, I-2 = 26%). The overall postoperative morbidity was significantly less in LADG than in ODG (relative risk = 0.58; 95% CI, 0.46-0.74; P < 0.00001; heterogeneity: P = 0.94, I-2 = 0%). LADG reduced the intraoperative blood loss, postoperative analgesic consumption, and hospital duration, without increasing the total hospitalization costs and cancer recurrence rate. The long-term survival rate of patients undergoing LADG was similar to that of patients undergoing ODG. However, LADG was still a technically dependent and time-consuming procedure. Conversion rate of LADG was 0% to 2.94%. The reported reasons for conversion were bleeding, adhesion, and safety resection margin requirement.Limitations: There were potential biases and significant heterogeneity in some clinical outcome measures in this study. Methodologically high-quality controlled clinical trials were sparse for this new surgical intervention. According to The Grading of Recommendations Assessment, Development and Evaluation approach, when assessing the safety and efficacy of LADG by comparing with those of ODG with the defined clinical outcomes in patients with EGC, the quality of the currently available clinical evidence was very low.Conclusions: LADG may be a technically feasible alternative for EGC when it is performed in experienced surgical centers in which patients undergoing LADG may benefit from the faster postoperative recovery. However, the currently available evidence cannot exclude the potential clinical benefits or harms, especially in the node-positive cases. Methodologically high-quality comparative studies are needed for further evaluation.