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胆管括约肌切开术后的不良事件:电流模式有影响吗?一项随机对照试验的系统评价和荟萃分析。

Adverse events after biliary sphincterotomy: Does the electric current mode make a difference? A systematic review and meta-analysis of randomized controlled trials.

作者信息

Funari Mateus Pereira, Ribeiro Igor Braga, de Moura Diogo Turiani Hourneaux, Bernardo Wanderley Marques, Brunaldi Vitor Ottoboni, Rezende Daniel Tavares, Resende Ricardo Hannum, de Marco Michele Oliveira, Franzini Tomazo Antonio Prince, de Moura Eduardo Guimarães Hourneaux

机构信息

Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC/FMUSP, Instituto Central, Prédio dos Ambulatórios, Av. Dr. Enéas de Carvalho Aguiar 255, Pinheiros, São Paulo, Brazil.

Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC/FMUSP, Instituto Central, Prédio dos Ambulatórios, Av. Dr. Enéas de Carvalho Aguiar 255, Pinheiros, São Paulo, Brazil.

出版信息

Clin Res Hepatol Gastroenterol. 2020 Oct;44(5):739-752. doi: 10.1016/j.clinre.2019.12.009. Epub 2020 Feb 20.

Abstract

BACKGROUND

Biliary sphincterotomy is an invasive method that allows access to the bile ducts, however, this procedure is not exempt of complications. Studies in the literature indicate that the mode of electric current used for sphincterotomy may carry different incidences of adverse events such as pancreatitis, hemorrhage, perforation, and cholangitis.

AIM

To evaluate the safety of different modes of electrical current during biliary sphincterotomy based on incidence of adverse events.

METHODS

We searched articles for this systematic review in Medline, EMBASE, Central Cochrane, Lilacs, and gray literature from inception to September 2019. Data from studies describing different types of electric current were meta-analyzed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The following electric current modalities were evaluated: endocut, blend, pure cut, pure cut followed by blend, monopolar, and bipolar.

RESULTS

A total of 1791 patients from 11 randomized clinical trials evaluating the following comparisons: 1. Endocut vs Blend: No statistical difference in the incidence of bleeding (7% vs 13.4%; RD: -0.11 [-0.31, 0.08], P=0.27, I=86%), pancreatitis (4.4% vs 3.5%; RD: 0.01 [-0.03, 0.04], P=0.62, I=48%) and perforation (absence of cases in both arms). 2. Endocut vs Pure cut: Higher incidence of mild bleeding (without drop in hemoglobin levels, clinical repercussion or need for endoscopic intervention) in the pure cut group (9.2% vs 28.8%; RD: -0.19 [-0.27, -0.12], P<0.00001, I=0%). No statistical difference regarding pancreatitis (5.2% vs 0.9%; RD: 0.05 [-0.01, 0.11], P=0.12, I=57%), perforation (0.4% vs 0%; RD: 0.00 [-0.01, 0.02], P=0.7, I=0%) or cholangitis (1.8% vs 3.2%; RD: -0.01 [-0.09, 0.06], P=0,7). 3. Pure cut vs blend: higher incidence of mild bleeding in the pure cut group (40.4% vs 16.7%; RD: 0.24 [0.15, 0.33], P<0.00001, I=0%). No statistical difference concerning incidence of pancreatitis or cholangitis. 4. Pure cut vs Pure cut followed by Blend: No statistical difference regarding incidence of bleeding (22.5% vs 11.7%; RD: -0.10 [-0.24, 0.04], P=0.18, I=61%) and pancreatitis (8.9% vs 14.8%; RD 0.06 [-0.02, 0.13], P=0.12, I=0%). 5. Blend vs pure cut followed by blend: no statistical difference regarding incidence of bleeding and pancreatitis (11.3% vs 10.4%; RD -0.01 [-0.11, 0.09], P=0.82, I=0%). 6. Monopolar vs bipolar: higher incidence of pancreatitis in the monopolar mode group (12% vs 0%; RD 0.12 [0.02, 0.22], P=0.01).

CONCLUSION

Pure cut carries higher incidences of mild bleeding compared to endocut and blend. However, this modality might present a lower incidence of pancreatitis. The monopolar mode elicits higher rates of pancreatitis in comparison with the bipolar mode. There is no difference in incidence of cholangitis or perforation between different types of electric current. There is a lack of evidence in the literature to recommend one method over the others, therefore new studies are warranted. As there is no perfect electric current mode, the choice in clinical practice must be based on the patient risk factors.

摘要

背景

胆管括约肌切开术是一种侵入性方法,可用于进入胆管,然而,该手术并非没有并发症。文献研究表明,用于括约肌切开术的电流模式可能导致不同发生率的不良事件,如胰腺炎、出血、穿孔和胆管炎。

目的

基于不良事件的发生率评估胆管括约肌切开术中不同电流模式的安全性。

方法

我们在Medline、EMBASE、Cochrane中心、Lilacs以及截至2019年9月的灰色文献中检索用于该系统评价的文章。根据系统评价和Meta分析的首选报告项目(PRISMA)对描述不同类型电流的研究数据进行Meta分析。评估了以下电流模式:内切、混合、纯切、先纯切后混合、单极和双极。

结果

来自11项随机临床试验的1791例患者参与了以下比较评估:1. 内切与混合:出血发生率(7%对13.4%;风险差:-0.11[-0.31,0.08],P=0.27,I²=86%)、胰腺炎发生率(4.4%对3.5%;风险差:0.01[-0.03,0.04],P=0.62,I²=48%)和穿孔发生率(两组均无病例)无统计学差异。2. 内切与纯切:纯切组轻度出血发生率更高(血红蛋白水平无下降、无临床影响或无需内镜干预)(9.2%对28.8%;风险差:-0.19[-0.27,-0.12],P<0.00001,I²=0%)。胰腺炎发生率(5.2%对0.9%;风险差:0.05[-0.01,0.11],P=0.12,I²=57%)、穿孔发生率(0.4%对0%;风险差:0.00[-0.01,0.02],P=0.7,I²=0%)或胆管炎发生率(1.8%对3.2%;风险差:-0.01[-0.09,0.06],P=0.7)无统计学差异。3. 纯切与混合:纯切组轻度出血发生率更高(40.4%对16.7%;风险差:0.24[0.15,0.33],P<0.00001,I²=0%)。胰腺炎或胆管炎发生率无统计学差异。4. 纯切与先纯切后混合:出血发生率(22.5%对11.7%;风险差:-0.10[-0.24,0.04],P=0.18,I²=61%)和胰腺炎发生率(8.9%对14.8%;风险差0.06[-0.02,0.13],P=0.12,I²=0%)无统计学差异。5. 混合与先纯切后混合:出血和胰腺炎发生率无统计学差异(11.3%对10.4%;风险差-0.01[-0.11,0.09],P=0.82,I²=0%)。6. 单极与双极:单极模式组胰腺炎发生率更高(12%对0%;风险差0.12[0.02,0.22],P=0.01)。

结论

与内切和混合相比,纯切的轻度出血发生率更高。然而,这种模式可能胰腺炎发生率较低。与双极模式相比,单极模式引发的胰腺炎发生率更高。不同类型电流之间胆管炎或穿孔发生率无差异。文献中缺乏推荐一种方法优于其他方法的证据,因此有必要进行新的研究。由于没有完美的电流模式,临床实践中的选择必须基于患者的风险因素。

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