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早期内镜逆行胰胆管造影(ERCP)±内镜括约肌切开术(ES)与保守治疗胆结石性胰腺炎(GSP)的Meta分析

Meta-Analysis of Early Endoscopic Retrograde Cholangiopancreatography (ERCP) ± Endoscopic Sphincterotomy (ES) Versus Conservative Management for Gallstone Pancreatitis (GSP).

作者信息

Burstow Matthew J, Yunus Rossita M, Hossain Md Belal, Khan Shahjahan, Memon Breda, Memon Muhammed A

机构信息

*Department of Surgery, Royal Brisbane and Women's Hospital †School of Agricultural, Computing and Environmental Sciences, Australian Centre for Sustainable Catchments, University of Southern Queensland, Toowoomba ∥Sunnybank Obesity Centre and SEQS, McCullough Centre, Sunnybank ¶Department of Surgery, Mayne Medical School, University of Queensland, Herston #Faculty of Health Sciences and Medicine, Bond University, Gold Coast, QLD, Australia ‡Institute of Mathematical Sciences, University of Malaya, Kuala Lumpur, Malaysia §Department of Statistics, Biostatistics & Informatics, Dhaka University, Dhaka, Bangladesh **Faculty of Health and Social Science, Bolton University, Bolton, Lancashire, UK.

出版信息

Surg Laparosc Endosc Percutan Tech. 2015 Jun;25(3):185-203. doi: 10.1097/SLE.0000000000000142.

Abstract

CONTEXT

The utility of early endoscopic retrograde cholangiopancreatography (ERCP) ± endoscopic sphincterotomy (ES) in the treatment of gallstone pancreatitis (GSP) is still contentious.

OBJECTIVES

The aim was to conduct a meta-analysis of randomized controlled trials (RCTs) investigating the treatment of GSP by early ERCP ± ES versus conservative management and analyzing the patient outcomes.

DATA SOURCES

A search of Medline, Embase, Science Citation Index, Current Contents, PubMed, and the Cochrane Database of Systematic Reviews identified all RCTs comparing early ERCP to conservative management in GSP published between January 1970 and January 2014. Search terms included "Endoscopic retrograde cholangiopancreatography (ERCP)"; "Endoscopic sphincterotomy"; "Gallstones"; "Bile duct stones"; "Gallstone pancreatitis"; "Biliary pancreatitis"; "Randomize/Randomised controlled trials"; "Conservative management/treatment"; "Human"; "English."

STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: Only prospective RCTs comparing early intervention (ie, between 24 and 72 h) with ERCP ± ES versus conservative management in GSP were included.

STUDY APPRAISAL AND SYNTHESIS METHODS

Data extraction and critical appraisal was carried out independently by 2 authors (M.J.B. and M.A.M.) using predefined data fields. Variables analyzed included severity of pancreatitis (mild or severe), overall mortality, overall complications which included pseudocyst formation, organ failure (renal, respiratory, and cardiac), abnormal coagulation, biliary sepsis, and development of pancreatic abscess/phlegmon. The quality of RCTs was assessed using Jadad's scoring system. Random-effects model was used to calculate the outcomes of both binary and continuous data. Heterogeneity among the outcome variables of these trials was determined by the Cochran Q statistic and I2 index. The meta-analysis was prepared in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines.

RESULTS

Eleven RCTs consisting of 1314 patients (conservative management=662, ERCP=652) were analyzed. There was a near significant decrease in mortality for ERCP group compared with conservatively managed patients with severe pancreatitis [odds ratio (OR) 0.45; 95% confidence interval (CI), 0.19, 1.09; P=0.08]. In patients with mild pancreatitis, mortality results were comparable for both groups (OR 0.66; 95% CI, 0.02, 28.75; P=0.83). Overall complications were significantly reduced in the ERCP group in severe pancreatic patients (OR 0.32; 95% CI, 0.17, 0.61; P=0.00). In those with mild disease, a strong trend to decreased complications in the ERCP group was seen, however, this was not significant (OR 0.67; 95% CI, 0.43, 1.03; P=0.06).

CONCLUSIONS

This meta-analysis demonstrates a significant decrease in complications in patients with severe GSP managed with early ERCP/ES compared with conservative management. As far as the mortality is concerned, no significant decrease was observed in mortality even in severe GSP patients treated with early ERCP/ES.

摘要

背景

早期内镜逆行胰胆管造影术(ERCP)±内镜括约肌切开术(ES)在治疗胆石性胰腺炎(GSP)中的效用仍存在争议。

目的

旨在对随机对照试验(RCT)进行荟萃分析,研究早期ERCP±ES与保守治疗相比在GSP治疗中的效果,并分析患者预后。

数据来源

检索Medline、Embase、科学引文索引、现刊目次、PubMed和Cochrane系统评价数据库,以确定1970年1月至2014年1月间发表的所有比较早期ERCP与GSP保守治疗的RCT。检索词包括“内镜逆行胰胆管造影术(ERCP)”;“内镜括约肌切开术”;“胆结石”;“胆管结石”;“胆石性胰腺炎”;“胆源性胰腺炎”;“随机/随机对照试验”;“保守治疗”;“人类”;“英文”。

研究入选标准、参与者和干预措施:仅纳入比较早期干预(即24至72小时之间)ERCP±ES与GSP保守治疗的前瞻性RCT。

研究评估和综合方法

由2位作者(M.J.B.和M.A.M.)使用预定义的数据字段独立进行数据提取和批判性评估。分析的变量包括胰腺炎的严重程度(轻度或重度)、总死亡率、总体并发症,其中包括假性囊肿形成、器官衰竭(肾、呼吸和心脏)、凝血异常、胆源性败血症以及胰腺脓肿/蜂窝织炎的发生。使用Jadad评分系统评估RCT的质量。采用随机效应模型计算二分类和连续性数据的结果。通过Cochran Q统计量和I²指数确定这些试验结果变量之间的异质性。荟萃分析按照PRISMA(系统评价和荟萃分析优先报告项目)指南进行。

结果

分析了11项RCT,共1314例患者(保守治疗=662例,ERCP=652例)。与保守治疗的重症胰腺炎患者相比,ERCP组的死亡率有近乎显著的降低[比值比(OR)0.45;95%置信区间(CI),0.19,1.09;P=0.08]。在轻度胰腺炎患者中,两组的死亡率结果相当(OR 0.66;95%CI,0.02,28.75;P=0.83)。在重症胰腺疾病患者中,ERCP组的总体并发症显著减少(OR 0.32;95%CI,0.17,0.61;P=0.00)。在轻症患者中,ERCP组并发症有减少的强烈趋势,然而并不显著(OR 0.67;95%CI,0.43,1.03;P=0.06)。

结论

该荟萃分析表明,与保守治疗相比,早期ERCP/ES治疗的重症GSP患者并发症显著减少。就死亡率而言,即使是接受早期ERCP/ES治疗的重症GSP患者,也未观察到死亡率有显著降低。

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