Alabdul Razzak Iyiad, Alenzi Maram, Fakhoury Butros, Zhang Xin-Yuan, Sandeep Krishnan, Mahmood Syed Kashif
Department of Internal Medicine, BIDMC, Harvard Medical School, Boston, MA 02115, United States.
Department of Gastroenterology and Hepatology, Boston Medical Center, Boston University, Boston, MA 02135, United States.
World J Gastrointest Endosc. 2025 Jun 16;17(6):105298. doi: 10.4253/wjge.v17.i6.105298.
Single-use duodenoscopes (SDs) were introduced to eliminate exogenous infection risks post-endoscopic retrograde cholangiopancreatography (ERCP).
To evaluate their efficacy and safety against reusable duodenoscopes (RDs).
This was a single-center case control study. All consecutive patients undergoing ERCP using SD between 2020 and 2023 were enrolled. A similar number of patients undergoing ERCP using RD were randomly selected and enrolled. In case of ERCP failure using SD, operators switched to a RD if judged appropriate. The primary outcome was successful ERCP completion rates. The secondary outcomes were rate of difficult biliary cannulation, incidence of crossover from SD to RD, procedure related adverse events, 30-day re-admission rate, and endoscopists' assessment of SD's performance.
A total of 133 patients were enrolled ( = 53 for SD, = 80 for RD). Baseline characteristics and American Society for Gastrointestinal Endoscopy ERCP complexity grades were comparable between both groups. Successful ERCP completion rates were 88.7% for SD and 95% for RD ( = 0.3). In cases of unsuccessful ERCP with SD, crossover to RD occurred in 3 out of 6 instances, with 2 subsequently succeeding with RD. Rates of adverse events and 30-day readmission were comparable: (1) 13.2% 11.2% ( = 0.19); and (2) 15.4% 8.9% ( = 0.25), respectively. Median overall endoscopists' satisfaction with SD was 8 out of 10.
The novel SDs demonstrated no difference in efficacy and safety compared to conventional RDs when used to perform a wide range of ERCPs. Nevertheless, further development and study of SDs' financial and environmental effectiveness is warranted.
一次性十二指肠镜（SDs）被引入以消除内镜逆行胰胆管造影（ERCP）术后的外源性感染风险。
评估其相对于可重复使用十二指肠镜（RDs）的有效性和安全性。
这是一项单中心病例对照研究。纳入了2020年至2023年间所有连续使用SD进行ERCP的患者。随机选择并纳入了数量相似的使用RD进行ERCP的患者。如果使用SD进行ERCP失败，操作人员在判断合适时会改用RD。主要结局是ERCP成功完成率。次要结局包括困难胆管插管率、从SD转换为RD的发生率、与操作相关的不良事件、30天再入院率以及内镜医师对SD性能的评估。
共纳入133例患者（SD组53例，RD组80例）。两组的基线特征和美国胃肠内镜学会ERCP复杂程度分级具有可比性。SD组的ERCP成功完成率为88.7%，RD组为95%（P = 0.3）。在使用SD进行ERCP失败的病例中，6例中有3例转换为RD，其中2例随后使用RD成功完成。不良事件发生率和30天再入院率具有可比性：（1）分别为13.2%对11.2%（P = 0.19）；（2）分别为15.4%对8.9%（P = 0.25）。内镜医师对SD的总体满意度中位数为8分（满分10分）。
在用于进行广泛的ERCP时，新型SDs与传统RDs相比，在有效性和安全性方面没有差异。尽管如此，仍有必要对SDs的财务和环境效益进行进一步的开发和研究。
