Abraham Neena S, Williams Stacey P, Thompson Kara, Love Jonathon R, MacIntosh Donald G
The Houston Center for Quality of Care and Utilization Studies, the Michael E. DeBakey VA Medical Center, Baylor College of Medicine, 2002 Holcombe Boulevard, Houston, TX 77030, USA.
Gastrointest Endosc. 2006 Apr;63(4):615-21. doi: 10.1016/j.gie.2005.10.041.
Cannulation of the common bile duct (CBD) is the first step in endoscopic retrograde cholangiopancreatography (ERCP). Cannulation difficulty is a known risk factor for post-ERCP complications and may be minimized by the use of a smaller caliber sphincterotome.
To compare the efficacy of CBD cannulation with a 4 F versus a 5 F sphincterotome.
A randomized controlled trial, with concealed allocation and double-blinding.
Adult patients undergoing their first ERCP at a tertiary referral center.
Patients were randomized to undergo CBD cannulation with either a 4 F or 5 F sphincterotome.
Successful deep cannulation in <15 attempts was the primary outcome. Secondary outcomes included number of attempts/time to cannulation, incidence of complications within 24 hours, and overall cannulation success (including patients before and after crossover). Analysis was intention to treat and included standard descriptive and inferential methods.
A total of 107 patients were randomized: 51 (4 F) versus 56 (5 F). The majority were female (71%) and white (92%). Baseline demographics, presenting symptoms, and laboratory values were similar between groups. Similar success in initial cannulation was observed: 84.3% (4 F) and 83.9% (5 F). No differences were noted in time to cannulation (5.12 min [SD, 4.8] for 4 F vs 4.46 min [SD, 4.13] for 5 F; p = NS), number of attempts to cannulation (6.2 [SD, 5.2] for 4 F vs 5.7 [SD, 4.9] for 5 F; p = NS), or complications. The overall cannulation success was 92.2% (4 F) and 92.9% (5 F).
Premature termination of the trial resulted in decreased power.
There exists no significant difference in efficacy between 4 F and 5 F sphincterotomes. The choice of initial sphincterotome should be dictated by physician preference.
胆总管插管是内镜逆行胰胆管造影术（ERCP）的第一步。插管困难是已知的ERCP术后并发症的危险因素，使用较小口径的括约肌切开刀可将其降至最低。
比较4F与5F括约肌切开刀进行胆总管插管的疗效。
一项随机对照试验，采用隐蔽分组和双盲法。
在三级转诊中心接受首次ERCP的成年患者。
患者被随机分配使用4F或5F括约肌切开刀进行胆总管插管。
15次尝试内成功深插管是主要观察指标。次要观察指标包括插管尝试次数/插管时间、24小时内并发症发生率以及总体插管成功率（包括交叉前后的患者）。分析采用意向性治疗，包括标准描述性和推断性方法。
共107例患者被随机分组：51例（4F组）和56例（5F组）。大多数为女性（71%）和白人（92%）。两组间基线人口统计学、临床表现和实验室值相似。初始插管成功率相似：4F组为84.3%，5F组为83.9%。插管时间（4F组为5.12分钟[标准差，4.8]，5F组为4.46分钟[标准差，4.13]；p =无显著性差异）、插管尝试次数（4F组为6.2次[标准差，5.2]，5F组为5.7次[标准差，4.9]；p =无显著性差异）或并发症方面均未发现差异。总体插管成功率4F组为92.2%，5F组为92.9%。
试验提前终止导致检验效能降低。
4F和5F括约肌切开刀在疗效上无显著差异。初始括约肌切开刀的选择应由医生偏好决定。
