新型国产经口胆胰直视化子镜系统用于胆道探查的安全性

Safety of a novel domestic direct visualization system of peroral cholangiopancreatoscopy for biliary tract exploration

摘要:

目的 评价新型国产经口胆胰直视化子镜系统在胆道探查中的安全性。方法 回顾性纳入上海市徐汇区中心医院内镜中心2017年11月至2022年12月因胆道疾病行内镜逆行胰胆管造影术（endoscopic retrograde cholangiopancreatography，ERCP）的384例患者。根据胆道探查应用胆道镜的不同，分为国产胆道镜组（159例）和SpyGlass组（225例）。国产胆道镜组在ERCP后采用新型国产经口胆胰直视化子镜系统进行胆道探查，SpyGlass组在ERCP后采用SpyGlass系统进行胆道探查。为排除混杂因素影响，采用倾向性评分匹配法将2组患者按照最近邻匹配法进行1∶1匹配，卡钳值为0.01，匹配后得到国产胆道镜组和SpyGlass组各122例患者。主要观察指标为短期并发症发生率，次要观察指标为技术成功率和治疗后处理。结果 倾向性评分匹配后，2组各122例患者纳入研究，组间所有基线资料比较差异无统计学意义（P>0.05）。术后短期并发症中，胰腺炎发生率国产胆道镜组和SpyGlass组分别为1.6%（2/122）和7.4%（9/122），国产胆道镜组操作后胰腺炎发生率低于SpyGlass组（χ2=4.665，P=0.031）；胆囊炎在国产胆道镜组未发生，SpyGlass组发生率为0.8%（1/122），两组操作后胆囊炎发生率差异无统计学意义（P=1.000）。技术成功率方面，国产胆道镜组和SpyGlass组分别为99.2%（121/122）和97.5%（119/122），国产胆道镜组成功率相对稍高，但差异无统计学意义（P=0.622）。术后胆道引流国产胆道镜组81例，SpyGlass组74例。结论 胆道系统疾病的胆道镜探查应用中，新型国产经口胆胰直视化子镜系统的安全性高于SpyGlass系统，可根据患者具体情况选择适合的胆道镜进行胆道疾病的直视下诊断和治疗。

Abstract:

Objective To assess the safety of a novel domestically developed direct visualization system of peroral cholangiopancreatoscopy for the exploration of biliary tract. Methods Clinical data from 384 patients with biliary tract diseases who underwent endoscopic retrograde cholangiopancreatography (ERCP) at the Endoscopy Center of Shanghai Xuhui District Central Hospital from November 2017 to December 2022 were retrospectively analyzed. Patients were categorized into 2 groups based on the type of cholangioscope: the novel cholangiopancreatoscopy system group (n=159) and the SpyGlass group (n=225). In the novel cholangiopancreatoscopy system group, the new direct visualization system of China‑made peroral cholangiopancreatoscopy was used for bile duct exploration, while the SpyGlass group utilized the SpyGlass system for bile duct inspection. Propensity score matching (PSM) was used as a nearest‑neighbor method with a caliper of 0.01 to minimize confounding factors, resulting in a balanced sample of 122 patients in each group after matching. The primary outcome was the incidence of short‑term complications, with secondary outcomes including technical success rates and post‑treatment outcomes. Results After PSM, there were no significant differences in baseline characteristics between the two groups (P>0.05). Regarding short‑term postoperative complications, pancreatitis occurred in 1.6% (2/122) of patients in the novel cholangiopancreatoscopy system group and 7.4% (9/122) in the SpyGlass group. The new system significantly reduced the incidence of post‑procedure pancreatitis (χ2=4.665, P=0.031). The cholecystitis was absent in the novel cholangiopancreatoscopy system group, while it occurred in 0.8% (1/122) cases in the SpyGlass group, with no significant difference between the two groups after the procedure (P=1.000). Regarding technical success rate, the novel system group achieved a rate of 99.2% (121/122), while the SpyGlass group achieved 97.5% (119/122) (P=0.622). A slightly higher success rate was observed in the novel system group.There were 81 cases of postoperative biliary drainage in the novel cholangiopancreatoscopy system group and 74 cases in the SpyGlass group. Conclusion The novel direct visualization system of peroral cholangiopancreatoscopy is safer than SpyGlass in the exploration of biliary system diseases. Endoscopists are encouraged to choose the appropriate cholangioscopy system based on individual patient characteristics for the direct visualization, diagnosis, and treatment of biliary diseases.