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经皮胆囊造瘘术治疗高危手术患者的急性结石性胆囊炎

Percutaneous cholecystostomy for high-risk surgical patients with acute calculous cholecystitis.

作者信息

Gurusamy Kurinchi Selvan, Rossi Michele, Davidson Brian R

机构信息

Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital,, Rowland Hill Street, London, UK, NW3 2PF.

出版信息

Cochrane Database Syst Rev. 2013 Aug 12(8):CD007088. doi: 10.1002/14651858.CD007088.pub2.

Abstract

BACKGROUND

The management of people at high risk of perioperative death due to their general condition (high-risk surgical patients) with acute calculous cholecystitis is controversial, with no clear guidelines. In particular, the role of percutaneous cholecystostomy in these patients has not been defined.

OBJECTIVES

To compare the benefits (temporary or permanent relief of symptoms) and harms (recurrence of symptoms, procedure-related morbidity) of percutaneous cholecystostomy in the management of high-risk individuals with symptomatic gallstones.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded to December 2012 to identify the randomised clinical trials. We also handsearched the references lists of identified trials.

SELECTION CRITERIA

We included only randomised clinical trials (irrespective of language, blinding, or publication status) addressing this issue.

DATA COLLECTION AND ANALYSIS

Two review authors collected data independently. For each outcome, we calculated the P values using Fisher's exact test or mean difference (MD) with 95% confidence intervals (CI).

MAIN RESULTS

We included two trials with 156 participants for this review. The comparisons included in these two trials were percutaneous cholecystostomy followed by early laparoscopic cholecystectomy versus delayed laparoscopic cholecystectomy (1 trial; 70 participants) and percutaneous cholecystostomy versus conservative treatment (1 trial; 86 participants). Both trials had high risk of bias. Percutaneous cholecystostomy with early laparoscopic cholecystectomy versus delayed laparoscopic cholecystectomy: There was no significant difference in mortality between the two intervention groups (0/37 versus 1/33; Fisher's exact test: P value = 0.47). There was no significant difference in overall morbidity between the two intervention groups (1/31 versus 2/30; Fisher's exact test: P value = 0.61). This trial did not report on quality of life. There was no significant difference in the proportion of participants requiring conversion to open cholecystectomy between the two intervention groups (2/31 percutaneous cholecystostomy followed by early laparoscopic cholecystectomy versus 4/30 delayed laparoscopic cholecystectomy; Fisher's exact test: P value = 0.43). The mean total hospital stay was significantly lower in the percutaneous cholecystostomy followed by early laparoscopic cholecystectomy group compared with the delayed laparoscopic cholecystectomy group (1 trial; 61 participants; MD -9.90 days; 95% CI -12.31 to -7.49). The mean total costs were significantly lower in the percutaneous cholecystostomy followed by early laparoscopic cholecystectomy group compared with the delayed laparoscopic cholecystectomy group (1 trial; 61 participants; MD -1123.00 USD; 95% CI -1336.60 to -909.40). Percutaneous cholecystostomy versus conservative treatment: Nine of the 44 participants underwent delayed cholecystectomy in the percutaneous cholecystostomy group. Seven of the 42 participants underwent delayed cholecystectomy in the conservative treatment group. There was no significant difference in mortality between the two intervention groups (6/44 versus 7/42; Fisher's exact test: P value = 0.77). There was no significant difference in overall morbidity between the two intervention groups (6/44 versus 3/42; Fisher's exact test: P value = 0.49). The number of participants who underwent laparoscopic cholecystectomy was not reported in this trial. Therefore, we were unable to calculate the proportion of participants who underwent conversion to open cholecystectomy. The other outcomes, total hospital stay, quality of life, and total costs, were not reported in this trial.

AUTHORS' CONCLUSIONS: Based on the current available evidence from randomised clinical trials, we are unable to determine the role of percutaneous cholecystostomy in the clinical management of high-risk surgical patients with acute cholecystitis. There is a need for adequately powered randomised clinical trials of low risk of bias on this issue.

摘要

背景

对于因一般状况而具有围手术期死亡高风险的人群(高风险手术患者),急性结石性胆囊炎的治疗存在争议,尚无明确的指南。特别是,经皮胆囊造瘘术在这些患者中的作用尚未明确。

目的

比较经皮胆囊造瘘术在有症状胆结石的高风险个体治疗中的益处(症状的暂时或永久缓解)和危害(症状复发、与手术相关的发病率)。

检索方法

我们检索了截至2012年12月的Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE和科学引文索引扩展版,以识别随机临床试验。我们还手工检索了已识别试验的参考文献列表。

选择标准

我们仅纳入针对此问题的随机临床试验(无论语言、盲法或发表状态如何)。

数据收集与分析

两位综述作者独立收集数据。对于每个结局,我们使用Fisher精确检验或均值差(MD)及95%置信区间(CI)计算P值。

主要结果

我们纳入了两项试验,共156名参与者进行本综述。这两项试验中的比较包括经皮胆囊造瘘术联合早期腹腔镜胆囊切除术与延迟腹腔镜胆囊切除术(1项试验;70名参与者)以及经皮胆囊造瘘术与保守治疗(1项试验;86名参与者)。两项试验均存在高偏倚风险。经皮胆囊造瘘术联合早期腹腔镜胆囊切除术与延迟腹腔镜胆囊切除术:两个干预组之间的死亡率无显著差异(0/37对1/33;Fisher精确检验:P值 = 0.47)。两个干预组之间的总体发病率无显著差异(1/31对2/30;Fisher精确检验:P值 = 0.61)。该试验未报告生活质量。两个干预组之间需要转为开腹胆囊切除术的参与者比例无显著差异(2/31为经皮胆囊造瘘术联合早期腹腔镜胆囊切除术对4/30为延迟腹腔镜胆囊切除术;Fisher精确检验:P值 = 0.43)。与延迟腹腔镜胆囊切除术组相比,经皮胆囊造瘘术联合早期腹腔镜胆囊切除术组的平均总住院时间显著缩短(1项试验;61名参与者;MD -9.90天;95% CI -12.31至 -7.49)。与延迟腹腔镜胆囊切除术组相比,经皮胆囊造瘘术联合早期腹腔镜胆囊切除术组的平均总成本显著降低(1项试验;61名参与者;MD -1123.00美元;95% CI -1336.60至 -909.40)。经皮胆囊造瘘术与保守治疗:经皮胆囊造瘘术组的44名参与者中有9人接受了延迟胆囊切除术。保守治疗组的42名参与者中有7人接受了延迟胆囊切除术。两个干预组之间的死亡率无显著差异(6/44对7/42;Fisher精确检验:P值 = 0.77)。两个干预组之间的总体发病率无显著差异(6/44对3/42;Fisher精确检验:P值 = 0.49)。该试验未报告接受腹腔镜胆囊切除术的参与者数量。因此,我们无法计算转为开腹胆囊切除术的参与者比例。该试验未报告其他结局,如总住院时间、生活质量和总成本。

作者结论

基于目前随机临床试验的现有证据,我们无法确定经皮胆囊造瘘术在急性胆囊炎高风险手术患者临床管理中的作用。需要针对此问题开展有足够样本量且偏倚风险低的随机临床试验。

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