Ozaslan Ersan, Purnak Tugrul, Efe Cumali, Ozaslan Nihal Gokbulut, Cengiz Mustafa
Department of Gastroenterology, Ankara Numune Education and Research Hospital, Çukurambar Mah. 1429. Cad. 24/2, Çankaya, Ankara, Turkey,
Dig Dis Sci. 2014 Dec;59(12):3078-84. doi: 10.1007/s10620-014-3268-2. Epub 2014 Jul 5.
There are scarce data regarding the impact of sphincterotome design on cannulation success. We aimed to compare two different 5.5 Fr standard sphincterotomes to determine initial cannulation success.
Adult patients with naive papillae were enrolled in a prospective, randomized, crossover study. Two different 5.5 Fr sphincterotomes preloaded with guidewire (GW) were used in two groups with 140 patients included per group. A total of five papillary attempts and two pancreatic channel entries were allowed as maximum targets. In a case of more than two pancreatic entries, a double GW technique was attempted before crossover. If choledochal cannulation was not achieved within ten papillary attempts or more than four pancreatic entries despite crossover, access papillotomy was performed. Successful biliary cannulation was the primary outcome. Secondary outcomes were incidence of early complications and overall cannulation success.
Higher initial cannulation success was achieved in group I compared with group II (88.5 vs. 77.1%, p = 0.011). The crossover and double GW techniques reduced the need for precut from 11.7 to 5.3%. The overall cannulation success including precut for failed cases was 99.2% (group I) and 98.5% (group II). Sphincterotome type, presence of crossover, and number of cannulation attempts were predictors of successful cannulation in multivariate analysis.
There was a significant difference in cannulation success between two different 5.5 Fr sphincterotomes. The cannulation success was mainly governed by sphincterotome design which serves a proper spatial orientation during the procedure. The combined use of crossover and double GW techniques may substantially decrease precut necessity.
关于括约肌切开刀设计对插管成功率的影响，相关数据匮乏。我们旨在比较两种不同的5.5F标准括约肌切开刀，以确定初始插管成功率。
纳入乳头未受损伤的成年患者进行一项前瞻性、随机、交叉研究。两组分别使用两种预先装载导丝（GW）的不同5.5F括约肌切开刀，每组纳入140例患者。总共允许进行五次乳头插管尝试和两次胰管进入作为最大目标。如果胰管进入超过两次，则在交叉前尝试双导丝技术。如果在十次乳头插管尝试内或交叉后胰管进入超过四次仍未实现胆管插管，则进行乳头开窗术。成功的胆管插管是主要结局。次要结局是早期并发症的发生率和总体插管成功率。
与第二组相比，第一组的初始插管成功率更高（88.5%对77.1%，p = 0.011）。交叉和双导丝技术将预切开的需求从11.7%降至5.3%。包括对失败病例进行预切开在内的总体插管成功率在第一组为99.2%，在第二组为98.5%。在多变量分析中，括约肌切开刀类型、交叉的存在以及插管尝试次数是插管成功的预测因素。
两种不同的5.5F括约肌切开刀在插管成功率上存在显著差异。插管成功率主要由括约肌切开刀设计决定，该设计在操作过程中提供适当的空间定向。交叉和双导丝技术的联合使用可能会大幅降低预切开的必要性。
