Albert Jörg G, Lucas Katja, Filmann Natalie, Herrmann Eva, Schröder Oliver, Sarrazin Christoph, Trojan Jörg, Kronenberger Bernd, Bojunga Jörg, Zeuzem Stefan, Friedrich-Rust Mireen
Department of Medicine 1, J. W. Goethe University Hospital, Frankfurt, Germany.
Institute of Biostatistics and Math Modeling, Faculty of Medicine, J. W. Goethe University, Frankfurt, Germany.
Endoscopy. 2014 Oct;46(10):857-61. doi: 10.1055/s-0034-1377628. Epub 2014 Sep 10.
During endoscopic retrograde cholangiopancreatography (ERCP), a guidewire is used to cannulate biliary strictures and allow for therapeutic interventions. The aim of this study was to assess the success of stricture cannulation using a combination of a flexible guidewire and a stable nitinol wire vs. a novel, single, stiff-shaft, flexible-tip guidewire.
Consecutive patients who were scheduled for ERCP for biliary obstruction were randomized to undergo the procedure with either a 260-cm long, angled-tip hydrophilic wire in combination with a nitinol wire as required (standard group), or a novel, 270-cm guidewire featuring a hyperflexible, hydrophilic tip with a stiff shaft (novel group). At unsuccessful negotiation of the stricture, patients in the standard group were switched to the novel guidewire and vice versa ("crossover"). Successful cannulation (primary success: as assigned; final success: after "crossover"), procedure time, and total number of wires needed per procedure were compared.
A total of 222 patients were randomized and 197 were included in the study (97 in the standard group and 100 in the novel group). The primary success rate was significantly higher in the novel group (94/100, 94 %) compared with the standard group (77/97, 79 %; P = 0.00041), and final success was similar. Mean time (median, interquartile range) to stricture cannulation was 11.2 minutes (6.3, 3.7 - 14.6) in the standard group and 8.1 minutes (2.5, 0.9 - 7.7) in the novel group (P < 0.0001). The mean total procedure time was 31.2 minutes (24.6, 16.5 - 40.8) vs. 24.3 minutes (16.9, 10.0 - 31.5), respectively (P = 0.0011). There were no complications observed with either of the guidewires.
A guidewire that features a flexible tip with a stable shaft could replace the use of a combination of flexible and stable guidewires and increase the success rate of stricture cannulation while decreasing the procedure time.ClinicalTrials.gov Identifier: NCT 01382680.
在经内镜逆行胰胆管造影术（ERCP）中，导丝用于插入胆管狭窄部位以进行治疗干预。本研究的目的是评估使用柔性导丝和稳定的镍钛诺导丝组合与一种新型单根硬杆柔性尖端导丝进行狭窄部位插管的成功率。
计划接受ERCP治疗胆管梗阻的连续患者被随机分为两组，一组使用一根260厘米长、带角度尖端的亲水导丝，并根据需要结合镍钛诺导丝（标准组），另一组使用一种新型的270厘米导丝，其特点是具有超柔性亲水尖端和硬杆（新型组）。在狭窄部位插管未成功时，标准组患者改用新型导丝，反之亦然（“交叉”）。比较成功插管率（初次成功：按分组情况；最终成功：“交叉”后）、操作时间以及每次操作所需导丝的总数。
共有222例患者被随机分组，197例纳入研究（标准组97例，新型组100例）。新型组的初次成功率（94/100，94%）显著高于标准组（77/97，79%；P = 0.00041），最终成功率相似。标准组插管至狭窄部位的平均时间（中位数，四分位间距）为11.2分钟（6.3，3.7 - 14.6），新型组为8.1分钟（2.5，0.9 - 7.7）（P < 0.0001）。平均总操作时间分别为31.2分钟（24.6，16.5 - 40.8）和24.3分钟（16.9，10.0 - 31.5）（P = 0.0011）。两种导丝均未观察到并发症。
一种具有柔性尖端和稳定杆的导丝可以替代柔性和稳定导丝的组合使用，提高狭窄部位插管的成功率，同时缩短操作时间。
NCT 01382680。
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