Background and Aims

Wire-guided biliary cannulation has been demonstrated to improve cannulation rates and reduce post-ERCP pancreatitis (PEP), but the impact of wire caliber has not been studied. This study compares successful cannulation rates and ERCP adverse events by using a 0.025-inch and 0.035-inch guidewire.

Methods

A randomized, single blinded, prospective, multicenter trial at 9 high-volume tertiary-care referral centers in the Asia-Pacific region was performed. Patients with an intact papilla and conventional anatomy who did not have malignancy in the head of the pancreas or ampulla and were undergoing ERCP were recruited. ERCP was performed by using a standardized cannulation algorithm, and patients were randomized to either a 0.025-inch or 0.035-inch guidewire. The primary outcomes of the study were successful wire-guided cannulation and the incidence of PEP. Overall successful cannulation and ERCP adverse events also were studied.

Results

A total of 710 patients were enrolled in the study. The primary wire-guided biliary cannulation rate was similar in 0.025-inch and 0.035-inch wire groups (80.7% vs 80.3%; P = .90). The rate of PEP between the 0.025-inch and the 0.035-inch wire groups did not differ significantly (7.8% vs 9.3%; P = .51). No differences were noted in secondary outcomes.

Conclusion

Similar rates of successful cannulation and PEP were demonstrated in the use of 0.025-inch and 0.035-inch guidewires. (Clinical trial registration number: NCT01408264.)

中文翻译：

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线径对ERCP结果的影响：0.025英寸和0.035英寸导丝的多中心随机对照试验

背景和目标

导线引导的胆管插管已被证明可提高插管率并减少ERCP后胰腺炎（PEP），但尚未研究线径的影响。本研究通过使用0.025英寸和0.035英寸导丝比较成功插管率和ERCP不良事件。

方法

在亚太地区的9个大型三级转诊中心进行了一项随机，单盲，前瞻性，多中心试验。征集了具有完整乳头和常规解剖结构，胰腺或壶腹头部无恶性肿瘤并接受ERCP的患者。ERCP通过使用标准化插管算法进行，患者被随机分为0.025英寸或0.035英寸的导丝。该研究的主要结果是成功的线引导插管和PEP的发生率。还研究了总体成功的插管和ERCP不良事件。

结果

该研究共招募了710名患者。在0.025英寸和0.035英寸的导线组中，主要的导线引导胆管插管率相似（80.7％对80.3％；P  = .90）。0.025英寸和0.035英寸电线组之间的PEP比率没有显着差异（7.8％对9.3％；P  = 0.51）。次要结局未见差异。

结论

在使用0.025英寸和0.035英寸导丝时，成功插管和PEP的成功率相似。（临床试验注册号：NCT01408264。）