2019 ASA | 胆源性胰腺炎:关于胆囊切除时机的随机对照试验
2019-04-12 来源:医脉通

医脉通编译整理,未经授权请勿转载。



第139届美国外科协会(ASA)年会于2019年4月11日至13日在美国达拉斯举行。ASA成立于1880年,是美国历史上最悠久、最负盛名的外科组织,其成员不仅包括来自美国的知名外科医生,还包括来自世界各地的顶尖外科医生。


协会还设立了年度科学奖以鼓励外科领域的优秀人才,从而提高外科临床的诊疗水平。ASA会议宗旨是全面提高临床手术、手术实验、相关科学以及外科手术护理的水平,协会的目的是汇集全球外科领域的专家和学者,以分享最新的临床和研究成果,旨在为大家临床工作提供帮助。


研究背景


根据既往的观察数据,研究人员提出了患者入院后早期行胆囊切除术治疗轻度胆源性胰腺炎(MGP)的观点。研究假设MGP患者入院后24h内行胆囊切除术,住院时间(LOS)缩短且并发症减少。


研究方法


研究人员将MGP患者随机分为入院24h内行胆囊切除术组(早期组)和临床缓解组(晚期组)。研究的主要终点是住院时间,包括再入院时间;次要终点是手术时间、内镜逆行胰胆管造影(ERCP)率以及术后并发症。最后,进行Frequentist和贝叶斯意向治疗分析。


研究结果


早期组(n=49)和晚期组(n=48)基线特征相似。早期组ERCP率较低(15% vs 29%,p=0.038),手术时间更短(16h vs 43h,p<0.005),住院时间更短(50h vs 77h,p<0.005)。


另外,两组并发症无显著差异(早期组6% vs 晚期组2%,p=0.613),包括胰腺炎复发/进展(早期组2例,晚期组1例)和1例早期组囊性残端漏。根据贝叶斯分析,早期胆囊切除术极大可能减少住院时间(概率99%),减少ERCP的使用(概率93%),但增加并发症概率为72%。


研究结论


对于MGP患者中,入院后24h内行胆囊切除术可显著降低ERCP率、手术时间和住院时间,可能会增加并发症,但研究未能显示其中的差异,有待进一步的调查研究。


附原文:


INTRODUCTION: Early cholecystectomy for mild gallstone pancreatitis (MGP) shortly after admission has been proposed based on observational data. We hypothesized that cholecystectomy within 24 hours of admission versus after clinical resolution of MGP results in decreased length-of-stay (LOS) without an increase in complications.


METHODS: Adults with MGP were randomized to cholecystectomy with cholangiogram within 24 hours of presentation (early group) versus after clinical resolution (late group). Primary outcome was 30-day LOS including any readmissions. Secondary outcomes were time to surgery, endoscopic retrograde cholangiopancreatography (ERCP) rates, and post-operative complications. Frequentist and Bayesian intention-to-treat analyses were performed.


RESULTS: Baseline characteristics were similar in the early (n=49) and late (n=48) groups. Early group had fewer ERCPs (15% vs 29%, p = 0.038), faster time to surgery (16 hours vs 43 hours, p<0.005), and shorter 30-day LOS (50 hours vs 77 hours, p<0.005). There was no significant difference in complications (6% early vs 2% late, p=0.613) which included recurrence/progression of pancreatitis (2 early, 1 late) and a cystic stump leak (early). On Bayesian analysis, early cholecystectomy has a 99% probability of reducing 30-day LOS, 93% probability of decreasing ERCP use, and 72% probability of increasing complications.


CONCLUSIONS: In patients with MGP, cholecystectomy within 24 hours of admission significantly reduced rate of ERCPs, time to surgery, and 30-day length-of-stay. Complications may be increased but the study is underpowered to detect a difference. Identification of patients with MGP in whom early cholecystectomy is safe warrants further investigation.


来源:ASA官网

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