Ishiwatari Hirotoshi, Kawakami Hiroshi, Hisai Hiroyuki, Yane Kei, Onodera Manabu, Eto Kazunori, Haba Shin, Okuda Toshinori, Ihara Hideyuki, Kukitsu Takehiro, Matsumoto Ryusuke, Kitaoka Keisuke, Sonoda Tomoko, Hayashi Tsuyoshi
Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan.
Department of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
Endoscopy. 2016 Apr;48(4):350-7. doi: 10.1055/s-0035-1569573. Epub 2016 Jan 13.
Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent. We therefore conducted a multicenter prospective randomized trial to compare catheter performance.
We enrolled patients with a BDS diameter ≤ 10 mm and common bile duct diameter ≤ 15 mm. Participants were randomly assigned to groups that were treated with basket or balloon catheters between October 2013 and September 2014. The primary endpoint was the rate of complete clearance of the duct; the secondary endpoints were the rate and time to complete clearance in one endoscopic session.
We initially enrolled 172 consecutive patients; 14 were excluded after randomization. The complete clearance rates were 92.3 % (72/78) in the balloon group and 80.0 % (64 /80) in the basket group. The difference in the rates between the two groups was 12.3 percentage points, indicating non-inferiority of the balloon method (non-inferiority limit -10 %; P < 0.001 for non-inferiority). Moreover, the balloon was superior to the basket (P = 0.037). The rate of complete clearance in one endoscopic session was 97.4 % using the balloon and 97.5 % using the basket (P = 1.00). The median times to complete clearance in one endoscopic session were 6.0 minutes (1 - 30) and 7.8 minutes (1 - 37) in the balloon and basket groups, respectively (P = 0.15).
For extraction of BDSs ≤ 10 mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.University Hospital Medical Information Network Trials Registry: UMIN000011887.
内镜下胆管结石（BDS）取出术是一种成熟的治疗方法；然而，对于采用网篮还是球囊导管进行结石取出，取决于操作者的偏好。因此，我们开展了一项多中心前瞻性随机试验，以比较两种导管的性能。
我们纳入了BDS直径≤10mm且胆总管直径≤15mm的患者。2013年10月至2014年9月期间，参与者被随机分配至使用网篮导管或球囊导管治疗的组中。主要终点是胆管完全清除率；次要终点是一次内镜检查中完全清除的率和时间。
我们最初连续纳入了172例患者；随机分组后排除了14例。球囊组的完全清除率为92.3%（72/78），网篮组为80.0%（64/80）。两组清除率的差异为12.3个百分点，表明球囊法不劣于网篮法（非劣效性界限为-10%；非劣效性检验P<0.001）。此外，球囊法优于网篮法（P=0.037）。一次内镜检查中使用球囊的完全清除率为97.４%，使用网篮的为97.5%（P=1.00）。球囊组和网篮组一次内镜检查中完成清除的中位时间分别为6.0分钟（1-30）和7.8分钟（1-37）（P=0.15）。
对于直径≤10mm的BDS取出，选择球囊导管比网篮导管更有可能通过单次导管实现完全内镜治疗。大学医院医学信息网络试验注册库：UMIN000011887。
