吻合器与手术刀切除后手工缝合胰残端切除术的比较。

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Pascal Probst, Felix J Hüttner, Ulla Klaiber, Phillip Knebel, Alexis Ulrich, Markus W Büchler, Markus K Diener
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引用次数: 0

摘要

背景:胰腺体和胰腺尾的切除到达肠系膜上静脉左侧被定义为远端胰腺切除术。大多数远端胰腺切除术是慢性胰腺炎、良性或恶性疾病的选择性治疗,其发病率高达40%。胰瘘的形成是术后发病率的主要来源,并与许多其他并发症相关。研究人员提出了几种手术切除和关闭胰腺残余的技术,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肢和订书机切除并缝合。目的:比较远端胰腺切除术中吻合器切除和缝合与手术刀切除后手工缝合胰腺残肢的效果。检索方法:我们检索了Cochrane中央对照试验注册库(Central)、MEDLINE和Embase,检索时间为数据库建立至2023年10月,ISGPS胰腺外科证据图谱检索时间为2025年4月9日。选择标准:我们纳入了随机对照试验(rct),比较了缝合手术与刀切除后手工缝合胰腺残肢的远端开放性胰腺切除术(无论语言或发表状态)。数据收集和分析:两位综述作者独立评估纳入试验并进行数据提取。我们感兴趣的结果是术后死亡率和发病率,特别是术后胰瘘。考虑到试验之间的临床异质性(例如不同的终点定义),我们使用RevMan中的随机效应模型分析数据,以95%置信区间(CI)计算风险比(RR)或平均差(MD)。我们使用GRADE来评估证据的确定性。主要结果:在三项试验中,共有515名参与者接受了远端胰腺切除术,并被随机分配到用订书机(n = 259)或用手术刀切除后再手工缝合(n = 256)关闭胰腺残端。一项研究为单中心先导RCT,两项研究为多中心RCT。单中心试点RCT评估了五个干预组(订书机、手工缝合、纤维蛋白胶、网片和胰空肠吻合术)的69名参与者,尽管我们只评估了订书机和手工缝合组(分别为14名和15名参与者)。这两个多中心随机对照试验有两个介入臂:订书机(n = 177和68)和手工缝合(n = 175和66)。与手术刀切除后再手工缝合相比,订书机可能对术后死亡率有相似的影响,尽管CI很宽(每1000人死亡4人,而每1000人死亡8人;RR 0.49, 95% CI 0.05 ~ 5.40;3相关;515名参与者;确定性的证据)。根据国际胰腺外科研究小组(ISGPS)的定义,与手术刀切除后再手工缝合相比,吻合器可能导致的术后胰瘘几乎没有差异(26%对29%;RR 1.11, 95% CI 0.84 ~ 1.47;2相关的;486名参与者;moderate-certainty证据)。与手术刀切除后再手工缝合相比,订书机可能导致的总体术后发病率几乎没有差异(63%对59%;RR 1.06, 95% CI 0.87 ~ 1.30;2相关的;486名参与者;moderate-certainty证据)。我们将所有结果的证据确定性降低了一个级别,原因是潜在的选择偏倚或与表现和检测偏倚相结合,并将术后死亡率的证据确定性降低了一个级别,原因是不精确。作者结论:证据主要基于两项多中心随机对照试验的结果。目前尚无关于该主题的随机对照试验。我们没有发现证据表明吻合器或手术刀切除后手工缝合胰残端切除术在术后胰瘘、术后总死亡率或手术时间方面优于远端胰切除术。目前,闭合的选择是留给个体外科医生的偏好和患者的解剖特征。未来对胰腺质地(软质与硬质)进行分层的试验可以为考虑不同胰腺质地的手术入路提供有价值的信息。未来评估残肢闭合新方法的试验应将其与订书机或手工缝合作为对照组进行比较,以确保结果的可比性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stapler versus scalpel resection followed by handsewn closure of the pancreatic remnant for distal pancreatectomy.

Background: 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.

Objectives: 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.

Search methods: 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.

Selection criteria: 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).

Data collection and analysis: 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.

Main results: 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.

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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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