Department of Surgery, McGovern Medical School at the University of Texas Health Science Center, Houston, TX.
Center for Surgical Trials and Evidence-based Practice (CSTEP), McGovern Medical School at the University of Texas Health Science Center, Houston, TX.
Ann Surg. 2019 Sep;270(3):519-527. doi: 10.1097/SLA.0000000000003424.
Early cholecystectomy shortly after admission for mild gallstone pancreatitis has been proposed based on observational data. We hypothesized that cholecystectomy within 24 hours of admission versus after clinical resolution of gallstone pancreatitis that is predicted to be mild results in decreased length-of-stay (LOS) without an increase in complications.
Adults with predicted mild gallstone pancreatitis were randomized to cholecystectomy with cholangiogram within 24 hours of presentation (early group) versus after clinical resolution (control) based on abdominal exam and normalized laboratory values. Primary outcome was 30-day LOS including readmissions. Secondary outcomes were time to surgery, endoscopic retrograde cholangiopancreatography (ERCP) rates, and postoperative complications. Frequentist and Bayesian intention-to-treat analyses were performed.
Baseline characteristics were similar in the early (n = 49) and control (n = 48) groups. Early group had fewer ERCPs (15% vs 29%, P = 0.038), faster time to surgery (16 h vs 43 h, P < 0.005), and shorter 30-day LOS (50 h vs 77 h, RR 0.68 95% CI 0.65 - 0.71, P < 0.005). Complication rates were 6% in early group versus 2% in controls (P = 0.613), which included recurrence/progression of pancreatitis (2 early, 1 control) and a cystic duct 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.
In patients with predicted mild gallstone pancreatitis, cholecystectomy within 24 hours of admission reduced rate of ERCPs, time to surgery, and 30-day length-of-stay. Minor complications may be increased with early cholecystectomy. Identification of patients with predicted mild gallstone pancreatitis in whom early cholecystectomy is safe warrants further investigation.
基于观察性数据,有人提出在轻度胆石性胰腺炎入院后不久行早期胆囊切除术。我们假设与预测为轻度的胆石性胰腺炎临床缓解后相比,入院后 24 小时内行胆囊切除术可减少住院时间( LOS )而不增加并发症。
根据腹部检查和实验室值正常化,将预测为轻度胆石性胰腺炎的成年人随机分为在入院后 24 小时内行胆囊切除术和胆管造影术(早期组)或在临床缓解后(对照组)。主要结局为包括再入院在内的 30 天 LOS 。次要结局为手术时间、内镜逆行胰胆管造影术( ERCP )率和术后并发症。进行了频率主义和贝叶斯意向治疗分析。
早期组( n =49)和对照组( n =48)的基线特征相似。早期组 ERCP 更少( 15%比 29%, P =0.038),手术时间更快( 16 小时比 43 小时, P <0.005),30 天 LOS 更短( 50 小时比 77 小时, RR 0.68 95%CI 0.65 - 0.71, P <0.005)。早期组并发症发生率为 6%,对照组为 2%( P =0.613),包括胰腺炎复发/进展( 2 例早期, 1 例对照组)和胆囊管残端漏(早期)。贝叶斯分析显示,早期胆囊切除术降低 30 天 LOS 的可能性为 99%,降低 ERCP 使用率的可能性为 93%,增加并发症的可能性为 72%。
在预测为轻度胆石性胰腺炎的患者中,入院后 24 小时内行胆囊切除术可降低 ERCP 率、手术时间和 30 天 LOS 。早期胆囊切除术可能会增加轻微并发症。进一步研究确定哪些预测为轻度胆石性胰腺炎患者行早期胆囊切除术是安全的,这是很有必要的。