Probst Pascal, Hüttner Felix J, Klaiber Ulla, Knebel Phillip, Ulrich Alexis, Büchler Markus W, Diener Markus K
Department of Surgery, Cantonal Hospital Thurgau, Frauenfeld, Switzerland.
Department of General, Visceral and Thoracic Surgery, Klinikum Nuremberg, Nuremberg, Germany.
Cochrane Database Syst Rev. 2025 Jun 10;6(6):CD008688. doi: 10.1002/14651858.CD008688.pub3.
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, and is 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 handsewn closure of the pancreatic remnant and stapler resection and closure.
To assess the effects of stapler resection and closure compared to scalpel resection followed by handsewn closure of the pancreatic remnant in people undergoing distal pancreatectomy.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from database inception to October 2023, and the ISGPS Evidence Map of Pancreatic Surgery to 9 April 2025.
We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by handsewn closure of the pancreatic remnant for open distal pancreatectomy (irrespective of language or publication status).
Two review authors independently assessed trials for inclusion and performed data extraction. Our outcomes of interest were postoperative mortality and morbidity, especially postoperative pancreatic fistula. Taking into account the clinical heterogeneity between trials (e.g. different endpoint definitions), we analysed data using a random-effects model in RevMan, calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI). We used GRADE to assess the certainty of evidence.
In three trials, a total of 515 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 259) or scalpel resection followed by handsewn closure (n = 256). One study was a single-centre pilot RCT, and two studies were multicentre RCTs. The single-centre pilot RCT evaluated 69 participants in five intervention arms (stapler, handsewn, fibrin glue, mesh, and pancreaticojejunostomy), although we only assessed the stapler and handsewn closure groups (14 and 15 participants, respectively). The two multicentre RCTs had two interventional arms: stapler (n = 177 and 68) and handsewn closure (n = 175 and 66). Stapler may have similar effects on postoperative mortality compared to scalpel resection followed by handsewn closure, although the CI is wide (4 deaths per 1000 compared with 8 per 1000; RR 0.49, 95% CI 0.05 to 5.40; 3 RCTs; 515 participants; low-certainty evidence). Stapler likely results in little to no difference in postoperative pancreatic fistula according to the International Study Group of Pancreatic Surgery (ISGPS) definition compared to scalpel resection followed by handsewn closure (26% versus 29%; RR 1.11, 95% CI 0.84 to 1.47; 2 RCTs; 486 participants; moderate-certainty evidence). Stapler likely results in little to no difference in overall postoperative morbidity compared to scalpel resection followed by handsewn closure (63% versus 59%; RR 1.06, 95% CI 0.87 to 1.30; 2 RCTs; 486 participants; moderate-certainty evidence). We downgraded the certainty of evidence for all outcomes by one level due to potential selection bias alone or in combination with performance and detection bias, and for postoperative mortality by a further level for imprecision.
AUTHORS' CONCLUSIONS: The evidence is mainly based on the results of two multicentre RCTs. There is no ongoing RCT on this topic. We did not find evidence to indicate that either stapler or scalpel resection followed by handsewn closure of the pancreatic remnant for distal pancreatectomy is superior in terms of postoperative pancreatic fistula, overall postoperative mortality, or operation time. Currently, the choice of closure is left to the preference of the individual surgeon and the anatomical characteristics of the patient. Future trials stratifying for pancreatic texture (soft versus hard) could add valuable information to inform surgical approaches when considering different pancreatic textures. Future trials assessing novel methods of stump closure should compare them either with stapler or handsewn 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,并与许多其他并发症相关。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和吻合器切除及闭合。
评估在接受远端胰腺切除术的患者中,与手术刀切除后手工缝合胰腺残端相比,吻合器切除及闭合的效果。
我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE和Embase,检索时间从数据库建立至2023年10月,并检索了国际胰腺手术研究小组(ISGPS)胰腺手术证据地图至2025年4月9日。
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开放性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)。
两位综述作者独立评估试验是否纳入并进行数据提取。我们感兴趣的结局是术后死亡率和发病率,尤其是术后胰瘘。考虑到试验之间的临床异质性(如不同的终点定义),我们在RevMan中使用随机效应模型分析数据,计算风险比(RR)或均值差(MD)及95%置信区间(CI)。我们使用GRADE评估证据的确定性。
在三项试验中,共有515名参与者接受了远端胰腺切除术,并被随机分配用吻合器闭合胰腺残端(n = 259)或手术刀切除后手工缝合(n = 256)。一项研究是单中心的试点RCT,两项研究是多中心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、网片和胰空肠吻合术)中评估了69名参与者,尽管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)。两项多中心RCT有两个干预组:吻合器(n = 177和68)和手工缝合闭合(n = 175和66)。与手术刀切除后手工缝合相比,吻合器对术后死亡率的影响可能相似,尽管置信区间较宽(每1000人中有4例死亡,而手工缝合为8例;RR 0.49,95%CI 0.05至5.40;3项RCT;515名参与者;低确定性证据)。根据国际胰腺手术研究小组(ISGPS)的定义,与手术刀切除后手工缝合相比,吻合器导致的术后胰瘘差异可能很小或无差异(26%对29%;RR 1.11,95%CI 0.84至1.47;2项RCT;486名参与者;中等确定性证据)。与手术刀切除后手工缝合相比,吻合器导致的总体术后发病率差异可能很小或无差异(63%对59%;RR 1.06,95%CI 0.87至1.30;2项RCT;486名参与者;中等确定性证据)。由于单独或与实施和检测偏倚相结合的潜在选择偏倚,我们将所有结局的证据确定性降低了一个等级,对于术后死亡率,由于不精确性,又降低了一个等级。
证据主要基于两项多中心RCT的结果。目前尚无关于该主题的正在进行的RCT。我们未发现证据表明,对于远端胰腺切除术,吻合器或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更具优势。目前,闭合方式的选择取决于外科医生个人的偏好和患者的解剖特征。未来针对胰腺质地(软与硬)进行分层的试验,在考虑不同胰腺质地时,可为手术方法提供有价值的信息。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。