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撤回。胆结石相关性急性胰腺炎的内镜逆行胰胆管造影术。

WITHDRAWN. Endoscopic retrograde cholangiopancreatography in gallstone-associated acute pancreatitis.

作者信息

Ayub Khurram, Slavin John, Imada Regina

机构信息

6 Griffin Close, Adderbury, Oxfordshire, UK, OX17 3HR.

出版信息

Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD003630. doi: 10.1002/14651858.CD003630.pub3.

Abstract

BACKGROUND

Early endoscopic retrograde cholangio-pancreatography with or without endoscopic sphincterotomy (ERCP+/-ES) has been advocated to reduce complications in patients presenting with a severe attack of gallstone-associated acute pancreatitis (GAP). However, a recent trial has reported contradictory results. Importantly, patients with acute cholangitis were excluded suggesting it may be a major confounding factor affecting previous studies.

OBJECTIVES

To assess the effectiveness of early ERCP+/-ES compared to conservative management stratified according to severity of disease, concealment of randomisation, acute cholangitis and bilirubin level in the reduction of mortality, morbidity, length of hospitalisation and cost in adults suspected of having GAP.

SEARCH STRATEGY

We searched - Cochrane Library (Issue 4 2003), Medline (1966-2004), EMBASE (1980-2004) and LILACS. 'Grey literature' was sought by looking at cited references and hand searched to identify further relevant trials. Conference proceedings of United European Gastroenterology Week (published in Gut) and Digestive Disease Week (published in Gastroenterology) were also hand searched.

SELECTION CRITERIA

Randomized controlled trials (RCT) of adult patients, from 15 years old or greater, presenting with gallstone-associated acute pancreatitis (GAP) comparing ERCP +/- ES versus Conservative management within 72 hours of admission.

DATA COLLECTION AND ANALYSIS

Data were assessed for quality independently by two reviewers. Wherever appropriate, results were pooled together and sub-grouped by predicted severity of disease. Fixed and random effects models were applied. Sensitivity analysis was performed to test the fragility of results.

MAIN RESULTS

Three trials, involving 511 patients, met inclusion criteria. The test for heterogeneity yielded statistically non-significant results (p-value 0.1 to 0.63) suggesting all comparisons were above the established threshold for combinability (p<0.1). Fixed effect and random effect meta-analyses gave identical results. Early ERCP +/- ES was associated with non-significant effect on reduction of mortality in predicted mild (OR = 0.62, 95% CI = 0.27 to 1.41) and severe GAP (OR = 0.62, 95% CI = 0.27 to 1.41). Reduction in complications was non-significant in predicted mild (OR = 0.89, 95% CI = 0.53 to 1.49), but significant in severe GAP (OR = 0.27, 95% CI = 0.14 to 0.53). There was insufficient evidence to draw any conclusions about hospital stay and cost.

AUTHORS' CONCLUSIONS: Odds of having complications are reduced in predicted severe disease by early ERCP +/- ES. This effect was however, non-significant in predicted mild disease and for reduction of mortality in either predicted mild or severe disease. These results are controlled for confounding due to associated acute cholangitis and are robust for clinical and statistical heterogeneity.

摘要

背景

早期内镜逆行胰胆管造影术(无论是否联合内镜括约肌切开术,即ERCP+/-ES)已被提倡用于降低胆结石相关性急性胰腺炎(GAP)重症发作患者的并发症发生率。然而,最近一项试验报告了相互矛盾的结果。重要的是,急性胆管炎患者被排除在外,这表明其可能是影响既往研究的一个主要混杂因素。

目的

评估早期ERCP+/-ES与根据疾病严重程度、随机分组的隐匿性、急性胆管炎及胆红素水平分层的保守治疗相比,在降低疑似GAP成年患者的死亡率、发病率、住院时间及费用方面的有效性。

检索策略

我们检索了——Cochrane图书馆(2003年第4期)、Medline(1966 - 2004年)、EMBASE(1980 - 2004年)和LILACS。通过查看引用参考文献来寻找“灰色文献”,并通过手工检索以识别更多相关试验。还手工检索了欧洲胃肠病学联合会周会议论文集(发表于《胃肠病学》)和消化系统疾病周会议论文集(发表于《胃肠病学杂志》)。

入选标准

年龄15岁及以上成年患者的随机对照试验(RCT),这些患者患有胆结石相关性急性胰腺炎(GAP),比较入院72小时内ERCP+/-ES与保守治疗。

数据收集与分析

由两名评价者独立评估数据质量。在适当情况下,将结果合并并按预测的疾病严重程度进行亚组分析。应用固定效应模型和随机效应模型。进行敏感性分析以检验结果的稳定性。

主要结果

三项试验,涉及511例患者,符合纳入标准。异质性检验产生了统计学上无显著意义的结果(p值为0.1至0.63),表明所有比较均高于既定的合并阈值(p<0.1)。固定效应和随机效应荟萃分析得出相同结果。早期ERCP+/-ES对预测为轻度(OR = 0.62,95%CI = 0.27至1.41)和重度GAP(OR = 0.62,95%CI = 0.27至1.41)患者的死亡率降低无显著影响。预测为轻度患者并发症的减少无显著意义(OR = 0.89,95%CI = 0.53至1.49),但在重度GAP患者中显著(OR = 0.27,95%CI = 0.14至0.53)。没有足够证据就住院时间和费用得出任何结论。

作者结论

早期ERCP+/-ES可降低预测为重度疾病患者发生并发症的几率。然而,这一效果在预测为轻度疾病患者中不显著,且对预测为轻度或重度疾病患者的死亡率降低也不显著。这些结果控制了因相关急性胆管炎导致的混杂因素,并且在临床和统计异质性方面具有稳健性。

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