前瞻性随机双盲对比研究短导丝内镜逆行胰胆管造影系统与传统长导丝设备。
Prospective randomized blinded comparison of a short-wire endoscopic retrograde cholangiopancreatography system with traditional long-wire devices.
机构信息
Department of Medicine, University of Florida, Gainesville, FL 32610, USA.
出版信息
Dig Dis Sci. 2010 Feb;55(2):510-5. doi: 10.1007/s10620-009-1052-5.
BACKGROUND
Short-wire endoscopic retrograde cholangiopancreatography (ERCP) systems are perceived to carry advantage over traditional long-wire devices. To date, this potential advantage has not been well documented, and gastroenterologists are confronted in everyday practice with the dilemma of choosing a particular system without the benefit of having objective comparative data.
AIMS
The aim of this study was to compare the performance characteristics of the Fusion ERCP short-wire system with traditional long-wire devices.
METHODS
This is a prospective, blinded, randomized, controlled trial. Patients with a clinical indication for ERCP were randomized to undergo the procedure with the Fusion short-wire system or long-wire devices. All procedures were done by one experienced endoscopist who was blinded to the outcomes of the study. The person recording the outcomes was an independent observer not involved in the procedure and was blinded to the study hypothesis. The main outcome was device exchange time. Secondary outcomes included stent insertion time, total procedure time, fluoroscopy time, cannulation time, successful cannulation of the desired duct, and complications.
RESULTS
A total of 71 patients were enrolled. The short-wire system provided for significantly faster mean device exchange time (125 versus 177 s; P = 0.05) and stent insertion time (135 versus 254 s; P < 0.001) as compared with the long-wire system. A trend towards shorter total procedure time, fluoroscopy time, and cannulation time was noted with the short-wire system but did not reach statistical significance. Successful cannulation of the desired duct was achieved in all patients. Post-ERCP pancreatitis occurred in one patient in the short-wire and in two patients in the long-wire group.
CONCLUSIONS
This short-wire system provides for significantly shorter device exchange and stent insertion times compared with traditional long-wire devices.
背景
短导丝内镜逆行胰胆管造影（ERCP）系统被认为优于传统的长导丝设备。迄今为止，这一潜在优势尚未得到很好的记录，在日常实践中，胃肠病学家面临着选择特定系统的困境，而没有获得客观比较数据的好处。
目的
本研究旨在比较 Fusion ERCP 短导丝系统与传统长导丝设备的性能特点。
方法
这是一项前瞻性、盲法、随机、对照试验。有 ERCP 临床适应证的患者被随机分为接受 Fusion 短导丝系统或长导丝设备进行的检查。所有的操作均由一位经验丰富的内镜医生进行，他对研究结果是盲法的。记录结果的人是一个独立的观察者，不参与该程序，并且对研究假设是盲法的。主要结果是器械交换时间。次要结果包括支架插入时间、总手术时间、透视时间、插管时间、所需胆管的成功插管和并发症。
结果
共纳入 71 例患者。与长导丝系统相比，短导丝系统的平均器械交换时间（125 秒比 177 秒；P = 0.05）和支架插入时间（135 秒比 254 秒；P < 0.001）明显更快。短导丝系统的总手术时间、透视时间和插管时间有缩短的趋势，但没有达到统计学意义。所有患者均成功插管。短导丝组 1 例和长导丝组 2 例患者发生术后胰腺炎。
结论
与传统的长导丝设备相比，该短导丝系统可显著缩短器械交换和支架插入时间。
Zotero 插件