Probst Pascal, Hüttner Felix J, Klaiber Ulla, Knebel Phillip, Ulrich Alexis, Büchler Markus W, Diener Markus K
Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany, D-69120.
Cochrane Database Syst Rev. 2015 Nov 6;2015(11):CD008688. doi: 10.1002/14651858.CD008688.pub2.
Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by hand-sewn closure of the pancreatic remnant and stapler resection and closure.
To compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by hand-sewn closure of the pancreatic remnant versus stapler resection and closure.
We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Biosis and Science Citation Index from database inception to October 2015.
We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy (irrespective of language or publication status).
Two authors independently assessed trials for inclusion and extracted the data. Taking into consideration the clinical heterogeneity between the trials (e.g. different endpoint definitions), we analysed data using a random-effects model with Review Manager (RevMan), calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).
In two eligible trials, a total of 381 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 191) or scalpel resection followed by hand-sewn closure (n = 190). One was a single centre pilot RCT and the other was a multicentre blinded RCT. The single centre pilot RCT evaluated 69 participants in five intervention arms (stapler, hand-sewn, fibrin glue, mesh and pancreaticojejunostomy), although we only assessed the stapler and hand-sewn closure groups (14 and 15 participants, respectively). The multicentre RCT had two interventional arms: stapler (n = 177) and hand-sewn closure (n = 175). The rate of postoperative pancreatic fistula was the main outcome, and it occurred in 79 of 190 participants in the hand-sewn group compared to 65 of 191 participants in the stapler group. Neither the individual trials nor the meta-analysis showed a significant difference between resection techniques (RR 0.90; 95% CI 0.55 to 1.45; P = 0.66). In the same way, postoperative mortality and operation time did not differ significantly. The single centre RCT had an unclear risk of bias in the randomisation, allocation and both blinding domains. However, the much larger multicentre RCT had a low risk of bias in all domains. Due to the small number of events and the wide confidence intervals that cannot exclude clinically important benefit or harm with stapler versus hand-sewn closure, there is a serious possibility of imprecision, making the overall quality of evidence moderate.
AUTHORS' CONCLUSIONS: The quality of evidence is moderate and mainly based on the high weight of the results of one multicentre RCT. Unfortunately, there are no other completed RCTs on this topic except for one relevant ongoing trial. Neither stapler nor scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula, overall postoperative mortality or operation time. Currently, the choice of closure is left up to the preference of the individual surgeon and the anatomical characteristics of the patient. Another (non-European) multicentre trial (e.g. with an equality or non-inferiority design) would help to corroborate the findings of this meta-analysis. Future trials assessing novel methods of stump closure should compare them either with stapler or hand-sewn closure as a control group to ensure comparability of results.
将胰体尾切除术范围延伸至肠系膜上静脉左侧的手术被定义为远端胰腺切除术。大多数远端胰腺切除术是针对慢性胰腺炎、良性或恶性疾病的择期治疗，其发病率高达40%。胰瘘形成是术后发病的主要原因，还会引发许多其他并发症。研究人员提出了几种胰腺残端的手术切除和闭合技术，试图减少这些并发症。两种最常见的技术是手术刀切除后手工缝合胰腺残端以及吻合器切除和闭合。
比较采用手术刀切除后手工缝合胰腺残端的远端胰腺切除术与吻合器切除和闭合术患者的胰瘘发生率。
我们检索了Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、EMBASE、Biosis和科学引文索引，检索时间从数据库建立至2015年10月。
我们纳入了比较吻合器与手术刀切除后手工缝合胰腺残端用于远端胰腺切除术的随机对照试验（RCT）（不考虑语言或发表状态）。
两位作者独立评估试验是否纳入并提取数据。考虑到试验之间的临床异质性（如不同的终点定义），我们使用Review Manager（RevMan）软件中的随机效应模型分析数据，计算风险比（RR）或均值差（MD）以及95%置信区间（CI）。
在两项符合条件的试验中，共有381名参与者接受了远端胰腺切除术，并被随机分为用吻合器闭合胰腺残端组（n = 191）或手术刀切除后手工缝合组（n = 190）。一项是单中心试点RCT，另一项是多中心盲法RCT。单中心试点RCT在五个干预组（吻合器、手工缝合、纤维蛋白胶、网膜和胰空肠吻合术）中评估了69名参与者，不过我们仅评估了吻合器和手工缝合闭合组（分别为14名和15名参与者）。多中心RCT有两个干预组：吻合器组（n = 177）和手工缝合闭合组（n = 175）。术后胰瘘发生率是主要结局，手工缝合组190名参与者中有79例发生胰瘘，而吻合器组191名参与者中有65例发生胰瘘。无论是单个试验还是荟萃分析，均未显示切除技术之间存在显著差异（RR 0.90；95% CI 0.55至1.45；P = 0.66）。同样，术后死亡率和手术时间也无显著差异。单中心RCT在随机化、分配和两个盲法领域的偏倚风险不明确。然而，规模大得多的多中心RCT在所有领域的偏倚风险较低。由于事件数量较少且置信区间较宽，无法排除吻合器与手工缝合闭合相比在临床上的重要益处或危害，存在严重的不精确可能性，使得证据的总体质量为中等。
证据质量为中等，主要基于一项多中心RCT结果的高权重。遗憾的是，除了一项正在进行的相关试验外，关于该主题没有其他已完成的RCT。对于远端胰腺切除术，无论是吻合器还是手术刀切除后手工缝合胰腺残端，在术后胰瘘、总体术后死亡率或手术时间方面，与另一种方法相比均未显示出任何优势。目前，闭合方法的选择取决于外科医生个人的偏好和患者的解剖特征。另一项（非欧洲的）多中心试验（如采用等效性或非劣效性设计）将有助于证实该荟萃分析的结果。未来评估新型残端闭合方法的试验应将其与吻合器或手工缝合闭合作为对照组进行比较，以确保结果的可比性。
