内镜逆行胰胆管造影术（ERCP）培训学员进行选择性胆管插管的适宜时机——一项随机试验
Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial.
作者信息
Pan Yanglin, Zhao Lina, Leung Joseph, Zhang Rongchun, Luo Hui, Wang Xiangping, Liu Zhiguo, Wan Bingnian, Tao Qin, Yao Shaowei, Hui Na, Fan Daiming, Wu Kaichun, Guo Xuegang
机构信息
Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xian, China.
Department of Radiotherapy, Xijing Hospital, Fourth Military Medical University, Xian, China.
出版信息
Endoscopy. 2015 Aug;47(8):688-95. doi: 10.1055/s-0034-1391564. Epub 2015 Mar 6.
BACKGROUND AND STUDY AIM
The allocation of sufficient time for trainees to attempt cannulation is necessary for learning and to ensure success with endoscopic retrograde cholangiopancreatography (ERCP) training. However, it is important to balance the benefit to trainee practice against the potential risks to patients. The appropriate time for attempted cannulation by trainees remains unclear.
PATIENTS AND METHODS
Three different time limits (5, 10, 15 minutes) were set for cannulation attempts made by four trainees in patients with native papilla undergoing ERCP. Patients were randomly assigned to the 5-, 10-, or 15-minute groups in a 1:1:1 ratio. Rectal indomethacin was used in high-risk patients. The primary outcome was successful cannulation within the allocated time. Secondary outcomes included performance scores, overall success rate, and post-ERCP pancreatitis (PEP).
RESULTS
A total of 256 patients were randomly assigned to the 5-minute (n = 84), 10-minute (n = 86), or 15-minute (n = 86) groups. Patients' baseline characteristics were comparable. Success rates for selective bile duct cannulation by trainees were 43.8 %, 75.0 %, and 71.8 % in the 5-, 10-, and 15-minute groups, respectively (P < 0.001). Trainees' self-reported performance scores and video assessment by an independent reviewer were comparable between the 10- and 15-minute groups, which were higher than the 5-minute group (both P < 0.001). Trainers took over the cannulation procedure when trainees did not succeed within the allocated time. There was no significant difference in the overall success rates in cannulation between the three groups. No differences were noted in the use of rectal indomethacin and overall complication rates. Four patients in each group developed PEP (P = 0.996).
CONCLUSION
A time of 10 minutes was considered to be appropriate for trainees to attempt cannulation, with acceptable cannulation success rates and complications.
TRIAL REGISTRATION
ClinicalTrials.gov number (NCT01851226).
背景与研究目的
为学员留出足够的时间尝试插管对于内镜逆行胰胆管造影术（ERCP）培训的学习和确保成功至关重要。然而，在学员实践的益处与对患者的潜在风险之间取得平衡也很重要。学员尝试插管的合适时间仍不明确。
患者与方法
为4名在接受ERCP的天然乳头患者中进行插管尝试的学员设定了3种不同的时间限制（5、10、15分钟）。患者按1:1:1的比例随机分配至5分钟、10分钟或15分钟组。高危患者使用直肠吲哚美辛。主要结局是在规定时间内成功插管。次要结局包括操作评分、总体成功率和ERCP术后胰腺炎（PEP）。
结果
共256例患者被随机分配至5分钟组（n = 84）、10分钟组（n = 86）或15分钟组（n = 86）。患者的基线特征具有可比性。5分钟组、10分钟组和15分钟组中学员选择性胆管插管的成功率分别为43.8%、75.0%和71.8%（P < 0.001）。10分钟组和15分钟组中学员自我报告的操作评分以及独立评审员的视频评估具有可比性，均高于5分钟组（P均< 0.001）。当学员在规定时间内未成功时，培训师接管插管操作。三组插管的总体成功率无显著差异。直肠吲哚美辛的使用和总体并发症发生率无差异。每组有4例患者发生PEP（P = 0.996）。
结论
10分钟被认为是学员尝试插管的合适时间，插管成功率和并发症均可接受。
试验注册
ClinicalTrials.gov编号（NCT01851226）。
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