Riviere Deniece, Gurusamy Kurinchi Selvan, Kooby David A, Vollmer Charles M, Besselink Marc G H, Davidson Brian R, van Laarhoven Cornelis J H M
Department of Surgery, Radboud University Nijmegen Medical Center, Nijmegen, Netherlands.
Cochrane Database Syst Rev. 2016 Apr 4;4(4):CD011391. doi: 10.1002/14651858.CD011391.pub2.
Surgical resection is currently the only treatment with the potential for long-term survival and cure of pancreatic cancer. Surgical resection is provided as distal pancreatectomy for cancers of the body and tail of the pancreas. It can be performed by laparoscopic or open surgery. In operations on other organs, laparoscopic surgery has been shown to reduce complications and length of hospital stay as compared with open surgery. However, concerns remain about the safety of laparoscopic distal pancreatectomy compared with open distal pancreatectomy in terms of postoperative complications and oncological clearance.
To assess the benefits and harms of laparoscopic distal pancreatectomy versus open distal pancreatectomy for people undergoing distal pancreatectomy for pancreatic ductal adenocarcinoma of the body or tail of the pancreas, or both.
We used search strategies to search the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded and trials registers until June 2015 to identify randomised controlled trials (RCTs) and non-randomised studies. We also searched the reference lists of included trials to identify additional studies.
We considered for inclusion in the review RCTs and non-randomised studies comparing laparoscopic versus open distal pancreatectomy in patients with resectable pancreatic cancer, irrespective of language, blinding or publication status..
Two review authors independently identified trials and independently extracted data. We calculated odds ratios (ORs), mean differences (MDs) or hazard ratios (HRs) along with 95% confidence intervals (CIs) using both fixed-effect and random-effects models with RevMan 5 on the basis of intention-to-treat analysis when possible.
We found no RCTs on this topic. We included in this review 12 non-randomised studies that compared laparoscopic versus open distal pancreatectomy (1576 participants: 394 underwent laparoscopic distal pancreatectomy and 1182 underwent open distal pancreatectomy); 11 studies (1506 participants: 353 undergoing laparoscopic distal pancreatectomy and 1153 undergoing open distal pancreatectomy) provided information for one or more outcomes. All of these studies were retrospective cohort-like studies or case-control studies. Most were at unclear or high risk of bias, and the overall quality of evidence was very low for all reported outcomes.Differences in short-term mortality (laparoscopic group: 1/329 (adjusted proportion based on meta-analysis estimate: 0.5%) vs open group: 11/1122 (1%); OR 0.48, 95% CI 0.11 to 2.17; 1451 participants; nine studies; I(2) = 0%), long-term mortality (HR 0.96, 95% CI 0.82 to 1.12; 277 participants; three studies; I(2) = 0%), proportion of people with serious adverse events (laparoscopic group: 7/89 (adjusted proportion: 8.8%) vs open group: 6/117 (5.1%); OR 1.79, 95% CI 0.53 to 6.06; 206 participants; three studies; I(2) = 0%), proportion of people with a clinically significant pancreatic fistula (laparoscopic group: 9/109 (adjusted proportion: 7.7%) vs open group: 9/137 (6.6%); OR 1.19, 95% CI 0.47 to 3.02; 246 participants; four studies; I(2) = 61%) were imprecise. Differences in recurrence at maximal follow-up (laparoscopic group: 37/81 (adjusted proportion based on meta-analysis estimate: 36.3%) vs open group: 59/103 (49.5%); OR 0.58, 95% CI 0.32 to 1.05; 184 participants; two studies; I(2) = 13%), adverse events of any severity (laparoscopic group: 33/109 (adjusted proportion: 31.7%) vs open group: 45/137 (32.8%); OR 0.95, 95% CI 0.54 to 1.66; 246 participants; four studies; I(2) = 18%) and proportion of participants with positive resection margins (laparoscopic group: 49/333 (adjusted proportion based on meta-analysis estimate: 14.3%) vs open group: 208/1133 (18.4%); OR 0.74, 95% CI 0.49 to 1.10; 1466 participants; 10 studies; I(2) = 6%) were also imprecise. Mean length of hospital stay was shorter by 2.43 days in the laparoscopic group than in the open group (MD -2.43 days, 95% CI -3.13 to -1.73; 1068 participants; five studies; I(2) = 0%). None of the included studies reported quality of life at any point in time, recurrence within six months, time to return to normal activity and time to return to work or blood transfusion requirements.
AUTHORS' CONCLUSIONS: Currently, no randomised controlled trials have compared laparoscopic distal pancreatectomy versus open distal pancreatectomy for patients with pancreatic cancers. In observational studies, laparoscopic distal pancreatectomy has been associated with shorter hospital stay as compared with open distal pancreatectomy. Currently, no information is available to determine a causal association in the differences between laparoscopic versus open distal pancreatectomy. Observed differences may be a result of confounding due to laparoscopic operation on less extensive cancer and open surgery on more extensive cancer. In addition, differences in length of hospital stay are relevant only if laparoscopic and open surgery procedures are equivalent oncologically. This information is not available currently. Thus, randomised controlled trials are needed to compare laparoscopic distal pancreatectomy versus open distal pancreatectomy with at least two to three years of follow-up. Such studies should include patient-oriented outcomes such as short-term mortality and long-term mortality (at least two to three years); health-related quality of life; complications and the sequelae of complications; resection margins; measures of earlier postoperative recovery such as length of hospital stay, time to return to normal activity and time to return to work (in those who are employed); and recurrence of cancer.
手术切除是目前唯一有可能使胰腺癌患者获得长期生存及治愈的治疗方法。对于胰腺体尾部癌,手术切除方式为胰体尾切除术。该手术可通过腹腔镜手术或开放手术进行。在其他器官的手术中,与开放手术相比,腹腔镜手术已被证明可减少并发症并缩短住院时间。然而,与开放胰体尾切除术相比,腹腔镜胰体尾切除术在术后并发症和肿瘤学切缘方面的安全性仍存在担忧。
评估对于因胰腺体尾部或二者皆有的导管腺癌而接受胰体尾切除术的患者,腹腔镜胰体尾切除术与开放胰体尾切除术的获益与危害。
我们运用检索策略,检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE、科学引文索引扩展版以及试验注册库,检索截至2015年6月,以识别随机对照试验(RCT)和非随机研究。我们还检索了纳入试验的参考文献列表以识别其他研究。
我们考虑纳入本综述的RCT和非随机研究,这些研究比较了可切除胰腺癌患者的腹腔镜与开放胰体尾切除术,无论语言、盲法或发表状态如何。
两位综述作者独立识别试验并独立提取数据。我们尽可能基于意向性分析,使用RevMan 5软件的固定效应和随机效应模型计算比值比(OR)、平均差(MD)或风险比(HR)以及95%置信区间(CI)。
我们未找到关于该主题的RCT。本综述纳入了12项比较腹腔镜与开放胰体尾切除术的非随机研究(1576名参与者:394例行腹腔镜胰体尾切除术,1182例行开放胰体尾切除术);11项研究(1506名参与者:353例行腹腔镜胰体尾切除术,1153例行开放胰体尾切除术)提供了一项或多项结局的信息。所有这些研究均为回顾性队列研究或病例对照研究。大多数研究存在不清楚或高偏倚风险,所有报告结局的证据总体质量非常低。短期死亡率差异(腹腔镜组:1/329(基于荟萃分析估计的调整比例:0.5%) vs 开放组:11/1122(1%);OR 0.48,95%CI 0.11至2.17;1451名参与者;9项研究;I² = 0%)、长期死亡率差异(HR 0.96,95%CI 0.82至1.12;277名参与者;3项研究;I² = 0%)、严重不良事件患者比例(腹腔镜组:7/89(调整比例:8.8%) vs 开放组:6/117(5.1%);OR 1.79,95%CI 0.53至6.06;206名参与者;3项研究;I² = 0%)、具有临床意义的胰瘘患者比例(腹腔镜组:9/109(调整比例:7.7%) vs 开放组:9/137(6.6%);OR 1.19,95%CI 0.47至3.02;246名参与者;4项研究;I² = 61%)均不精确。最大随访期复发差异(腹腔镜组:37/81(基于荟萃分析估计的调整比例:36.3%) vs 开放组:59/103(49.5%);OR 0.58,95%CI 0.32至1.05;184名参与者;2项研究;I² = 13%)、任何严重程度的不良事件差异(腹腔镜组:33/109(调整比例:31.7%) vs 开放组:45/137(32.8%);OR 0.95,95%CI 0.54至1.66;246名参与者;4项研究;I² = 18%)以及手术切缘阳性的参与者比例(腹腔镜组:49/333(基于荟萃分析估计的调整比例:14.3%) vs 开放组:208/1133(18.4%);OR 0.74,95%CI 0.49至1.10;1466名参与者;10项研究;I² = 6%)也不精确。腹腔镜组的平均住院时间比开放组短2.43天(MD -2.43天,95%CI -3.13至-1.73;1068名参与者;5项研究;I² = 0%)。纳入的研究均未在任何时间点报告生活质量、六个月内复发、恢复正常活动时间、恢复工作时间或输血需求。
目前,尚无随机对照试验比较腹腔镜胰体尾切除术与开放胰体尾切除术对胰腺癌患者的疗效。在观察性研究中,与开放胰体尾切除术相比,腹腔镜胰体尾切除术与较短的住院时间相关。目前,尚无信息可确定腹腔镜与开放胰体尾切除术之间差异的因果关联。观察到的差异可能是由于腹腔镜手术针对的癌症范围较小,而开放手术针对的癌症范围较大导致的混杂结果。此外,仅当腹腔镜和开放手术在肿瘤学上等效时,住院时间的差异才有意义。目前尚无此信息。因此,需要进行随机对照试验来比较腹腔镜胰体尾切除术与开放胰体尾切除术,并至少随访两到三年。此类研究应包括以患者为导向的结局,如短期死亡率和长期死亡率(至少两到三年);与健康相关的生活质量;并发症及并发症后遗症;手术切缘;术后早期恢复指标,如住院时间、恢复正常活动时间和恢复工作时间(对于有工作的患者);以及癌症复发。