导丝的粗细对ERCP带来的影响

0.025' 和0.035'导丝在ERCP插管成功率和术后胰腺炎发生率上是否有差别？？

ERCP是胆胰疾病管理操作方面的中流砥柱。从1968年以来，这项技术的进展迅猛影响深远。不过困扰诊治效果的两大绊脚石也一路相随，也就是选择性胆管插管的失败和ERCP术后胰腺炎。如果不是高手术量的专业中心，胆管插管的失败率可高达20%；进而导致反复的尝试、操作时间的延长、术后胰腺炎风险的增高和治疗的延迟。

已经有荟萃分析证明导丝插管相比导管（造影剂）插管可以改善成功率并降低ERCP术后胰腺炎发生率。然而在导丝直径对插管成功率和术后胰腺炎发生率的影响尚缺乏专门的研究。而又有说法声称0.025英寸导丝由于其更细、更柔韧，对壶腹和胆管的创伤更小，但是没有明显的证据。而这篇最近的发布的研究正好着眼于这个问题。摘要如下供大家参考。

导丝直径对ERCP结果的影响：一项0.025英寸和0.035英寸导丝的多中心随机对照试验

The impact of wire caliber on ERCP outcomes:a multicenter randomized controlled trial of 0.025-inch and 0.035-inch guidewires 

GASTROINTESTINAL ENDOSCOPY 

Volume 87, No. 6 : 2018

背景和目的：

导丝引导下胆管插管已被证明可以提高插管成功率并减少ERCP术后胰腺炎(PEP),但导丝直径对于这方面的的影响尚未被研究过。本研究对比使用0.025英寸和0.035英寸导丝，在插管成功率和ERCP不良事件上的不同。

方法：

在亚太地区9个高手术量的三级转诊医学中心进行了随机、单盲、前瞻性、多中心试验。被招募的患者为，括约肌乳头完好、解剖结构常规,在胰腺头部或壶腹部没有恶性肿瘤的,正在接受ERCP治疗的患者。患者被随机分配至使用0.025英寸导丝或0.035英寸导丝的研究组，这些组所实施的ERCP为标准化插管方式。研究的主要关注结果是导丝引导下乳头插管成功情况和PEP发生率。同时也一并研究乳头插管总体成功率和ERCP不良事件。

结果：

共有710名患者参与了这项研究。0.025英寸和0.035英寸导丝组的初次插管成功率相近(80.7%对80.3%;P Z .90)。PEP（ERCP术后胰腺炎）发病率在0.025 英寸导丝组和0.035 英寸导丝组之间没有显著差异(7.8% vs 9.3%;P Z .51)。在次要结果中也未注意到任何差异。

结论：

使用0.025 英寸和0.035 英寸导丝在插管成功率和ERCP术后胰腺炎发生率方面是差不多的。(临床试验注册号:NCT01408264)

附：文献摘要原文

The impact of wire caliber on ERCP outcomes:a multicenter randomized controlled trial of 0.025-inch and 0.035-inch guidewires 

Milan S. Bassan, MBBS, Praka Sundaralingam, MBBS, Scott B. Fanning, MBBS, James Lau, MBBS, MD,Jayaram Menon, MBBS, Evan Ong, MD, Rungsun Rerknimitr, MD, Dong-Wan Seo, MD, PhD, Eng Kiong Teo, MBBS, Hsiu-Po Wang, MD, D. Nageshwar Reddy, MD, DM, DSc,Khean Lee Goh, KSD, PDMP, MD, MBBS, Michael J. Bourke, MBBS

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%; PZ .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%; PZ .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.) (Gastrointest Endosc 2018;87:1454-60.)