Department of Gastroenterology and Hepatology, Westmead Hospital, New South Wales, Australia.
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.
Gastrointest Endosc. 2018 Jun;87(6):1454-1460. doi: 10.1016/j.gie.2017.11.037. Epub 2018 Jan 6.
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.
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.
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.
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.).
导丝引导下的胆管插管已被证明可提高插管成功率并降低内镜逆行胰胆管造影术后胰腺炎（PEP）的发生率，但导丝直径的影响尚未得到研究。本研究比较了使用 0.025 英寸和 0.035 英寸导丝的成功插管率和内镜逆行胰胆管造影术不良事件。
在亚太地区 9 家高容量三级转诊中心进行了一项随机、单盲、前瞻性、多中心试验。纳入了具有完整乳头和常规解剖结构、胰腺头部无恶性肿瘤或壶腹无恶性肿瘤且正在接受内镜逆行胰胆管造影术的患者。通过标准化的插管算法进行内镜逆行胰胆管造影术，患者随机分为 0.025 英寸导丝或 0.035 英寸导丝组。本研究的主要结局是成功的导丝引导下胆管插管和 PEP 的发生率。还研究了总体成功插管和内镜逆行胰胆管造影术不良事件。
共有 710 名患者入组本研究。0.025 英寸导丝和 0.035 英寸导丝组的主要导丝引导下胆管插管成功率相似（80.7% vs. 80.3%；P =.90）。0.025 英寸导丝组和 0.035 英寸导丝组的 PEP 发生率无显著差异（7.8% vs. 9.3%；P =.51）。次要结局无差异。
使用 0.025 英寸和 0.035 英寸导丝的成功率和 PEP 发生率相似。（临床试验注册号：NCT01408264。）
