基于累积和分析法的外科ERCP术者学习曲线分析

Learning curve for surgeons implementing surgical ERCP based on cumulative sum analysis

目的对外科完成经内镜胰胆管造影术(ERCP)规范化培训后的独立术者成长期所有病例进行回顾性研究,分析术后并发症发生情况,并绘制其学习曲线。方法确定ERCP操作过程中的可量化评价标准包括乳头插管时间、手术并发症(急性胰腺炎、出血、穿孔、急性胆管炎)发生率、尝试插管次数等六项,采集自2018年7月至2020年12月全部的ERCP手术操作记录中以上参数的具体值进行统计分析,学习曲线评价指标计算公式为:δ=Xi-X0,计算每一次操作的6个评价指标的累积和值即该次ERCP操作水平量化值的总和(∑=δ1+δ2+δ3+δ4+δ5+δ6),量化后绘制学习曲线并分析学习期术后并发症发生率。结果该术者总体插管成功率为99.4%,高于一般文献报道的独立ERCP操作术者的插管成功率要求。取前100例ERCP操作病例绘制CUSUM控制图并拟合学习曲线。拟合曲线公式:y=10.7001+0.1020x+0.008372x2-0.000089x3,决定系数R2=0.899,曲线拟合效果较好。68例ERCP手术后,曲线k值为负,故68例ERCP手术后,该术者跨越学习曲线。结论外科术者即使没有内镜基础直接进行ERCP操作培训完全可以胜任ERCP手术,其插管成功率及手术并发症发生情况较文献报道的无明显升高。

Objective To retrospectively study all the surgeons receiving independent surgeries in the growth period following the standardized trainings on endoscopic retrograde cholangiopancreatography(ERCP)in a surgery department of the hospital,analyze the postoperative complications,draw its learning curve.Methods Six items of quantifiable evaluation criteria during ERCP including the papillary cannulation duration,incidence of surgical complications(acute pancreatitis,hemorrhage,perforation,acute cholangitis)and number of cannulation attempts were determined,the specific values of the above parameters in all ERCP surgery records from July 2018 to December 2020 were collected for statistical analysis.The calculation formula of learning curve evaluation index was found to beδ=Xi-X0,the cumulative sum of six evaluation indicators for each operation,i.e.the sum of the quantitative values of ERCP operation level(∑=δ1+δ2+δ3+δ4+δ5+δ6)was calculated,the learning curve was drawn after quantification,and the incidence of postoperative complications during the learning period was analyzed.Results The overall cannulation success rates were 99.4%,and which were higher than those of the report for independent ERCP surgeons required.The first 100 ERCP operating cases were selected to draw the control drawing for cumulative sum(CUSUM)control chart and fit the learning curve,the formula for the learning curve fitted satisfied y=10.7001+0.1020x+0.008372x2-0.000089x3,determination coefficient,R2=0.899,and the curve fitting effect was better.Keratometric values(K-value)of curve turned to be negative after 68 cases in the present study,consequently,the surgeon crossed the learning stage after 68 cases of ERCP.Conclusion Surgical ERCP surgeons are eligible for ERCP even if they receive ERCP operation training without endoscopic basis,and the cannulation success rate and postoperative complications are not significantly higher than those reported in the literature.