内镜胆管取石之网篮与气囊的对比应用:一项多中心随机试验(翻译)

时间:2018-08-13 作者:翻译:于廷廷 审校: 点击:

内镜胆管取石之网篮与气囊的对比应用:一项多中心随机试验

背景及研究目的:内镜下胆管取石术是一项成熟的治疗方法。然而,应用网篮还是气囊取决于操作者的个人喜好。因此,我们进行了一项随机对照试验来比较这两种导管的优越性。
患者及方法:我们纳入了胆管结石直径≤10mm,胆总管直径≤15mm的患者。在2013年10月至2014年9月期间,参与者被随机分为应用网篮组和应用气囊组。该实验的主要终点是胆管完全清空率;次要终点是在一次内镜治疗过程中胆管完全清空的速度和时间。
结果:我们最初纳入了172例患者,随机分组后排除14例。在气囊组完全清空率为92.3%(72/78),网篮组为80%(64/80)。两组之间的差异为12.3个百分点,表明气囊取石方法的非劣效性(非劣效性界值-10%;非劣效性P< 0.001)。而且,取石气囊优于取石网篮。在一次内镜治疗过程中,应用气囊和网篮的完全清空率分别为97.4%(P=1.00),中位时间分别为6分钟(1-30)和7.8分钟(1-37),P=0.15。
结论:对于取出直径≤10mm的结石,若内镜下只使用一种导管进行完全取石,应用取石气囊似乎更优于取石网篮。


Balloon catheter versus basket catheter for endoscopic bile duct stone extraction: a multicenter randomized trial

Ishiwatari H, Kawakami H, Hisai H, et al. [J]. Endoscopy, 2016, 48(04):350-357.

Background and study aims: 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.
 
Patients and methods: We enrolled patients with a BDS diameter ≤10mm and common bile duct diameter ≤15mm. 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.
 
Results: 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).

Conclusions: For extraction of BDSs≤10mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.

取石气囊:波士顿科学院,日本,型号:Extractor Pro XL 或者 Extractor Pro RX
取石网篮:奥林巴斯,日本,型号:Flower Basket V

翻译:于廷廷  审校:张立超、侯森林