BACKGROUND:Despite the recent improvement in techniques and patient selection, post-ERCP pancreatitis remains the most frequent and dreaded complication of ERCP. Recent studies suggest that pretreatment with glyceryl trinitrate (GTN) may prevent post-ERCP pancreatitis and improve cannulation success. OBJECTIVE:To evaluate the effect of transdermal GTN on ERCP cannulation success and post-ERCP pancreatitis. DESIGN:Prospective, double-blind, placebo-controlled trial. SETTING:Tertiary referral university hospital. PATIENTS:A total of 318 patients (mean age 62 years, 61% women) were randomized to either active (n = 155) or placebo (n = 163) arms. INTERVENTIONS:Active patch (GTN) versus placebo patch. MAIN OUTCOME MEASUREMENTS:Cannulation time and success. Post-ERCP pancreatitis rates. RESULTS:There was no significant difference between the active or placebo arms for the following: successful initial cannulation (96.8% vs 98.8%), deep cannulation (96.1% vs 98.8%), time to successful cannulation, use of guidewire (27% vs 25%) or needle knife (13% vs 13%), and post-ERCP pancreatitis (7.4% of placebo patients and 7.7% active patients). Multivariate analysis identified women, younger patients, pancreatogram, number of attempts on papilla, and poor pancreatic-duct emptying after opacification as risk factors for post-ERCP pancreatitis. Transdermal GTN did not reduce post-ERCP pancreatitis in any of the identified high-risk groups. CONCLUSIONS:Transdermal GTN did not improve the rate of success in ERCP cannulation or prevent post-ERCP pancreatitis in either average or high-risk patient groups.

译文

背景:尽管最近在技术和患者选择方面已有改进,但ERCP后胰腺炎仍然是ERCP最常见和最可怕的并发症。最近的研究表明,用三硝酸甘油酯(GTN)进行预处理可以预防ERCP后胰腺炎并提高插管成功率。
目的:评价经皮GTN对ERCP插管成功和ERCP术后胰腺炎的影响。
设计:一项前瞻性,双盲,安慰剂对照试验。
单位:大专转诊大学医院。
患者:共有318例患者(平均年龄62岁,女性占61%)被随机分配到活动组(n = 155)或安慰剂组(n = 163)。
干预措施:主动贴片(GTN)与安慰剂贴片。
主要观察指标:排尿时间和成功率。 ERCP后胰腺炎发生率。
结果:主动或安慰剂组之间在以下方面没有显着差异:成功的初始插管(96.8%vs 98.8%),深层插管(96.1%vs 98.8%),成功插管的时间,使用导丝(27%vs 25%)或针刀(13%比13%)以及ERCP后胰腺炎(安慰剂患者为7.4%,活动患者为7.7%)。多变量分析确定女性,年轻患者,胰腺造影,乳头尝试次数以及混浊后胰管排空不良是ERCP后胰腺炎的危险因素。在任何已确定的高危人群中,经皮GTN均不能减轻ERCP后胰腺炎的发生。
结论:无论是普通患者还是高危患者,经皮GTN均不能提高ERCP插管成功率或预防ERCP术后胰腺炎。

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