Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA.
Asian Institute of Gastroenterology, Hyderabad, India.
Am J Gastroenterol. 2019 Feb;114(2):339-347. doi: 10.14309/ajg.0000000000000049.
Rectal indomethacin and topical spray of epinephrine have separately shown efficacy in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in randomized controlled trials. We hypothesized that the combination of indomethacin and topical spray of epinephrine on the duodenal papillae would further reduce PEP than when indomethacin was used alone.
We conducted a comparative effectiveness, multicenter, double-blinded, randomized trial of rectal indomethacin alone vs a combination of rectal indomethacin and topical spray of epinephrine for the prevention of PEP in high-risk patients. The primary outcome was the incidence of PEP and the secondary outcome was the severity of PEP. A 2-tailed Fisher's exact test was used to analyze the difference in the proportion of patients with PEP in the indomethacin alone vs the combination group.
A total of 960 patients (mean age 52.33 ± 14.96 years; 551 [57.4%] females) were randomized and 959 completed follow-up. The baseline demographic and clinical characteristics were similar between the 2 groups. Women <50 years of age (25.4%) and difficult cannulation (84.9%) were the most common PEP risk factors. The incidence of PEP was 6.4% in the indomethacin alone group (n = 482) compared to 6.7% in the combination group (n = 477; P = 0.87). Severe PEP was found in 5 (12%) and 7 (16%) patients in the indomethacin alone and combination groups, respectively (P = 0.88). The overall mortality was 0.6%, which was unrelated to the primary outcome.
The combination of rectal indomethacin and topical spray of epinephrine does not reduce the incidence of PEP compared to rectal indomethacin alone in high-risk patients; https://clinicaltrials.gov/ct2/show/NCT02116309.
直肠吲哚美辛和局部喷洒肾上腺素在随机对照试验中分别显示出预防内镜逆行胰胆管造影术后胰腺炎（PEP）的疗效。我们假设，在十二指肠乳头局部喷洒肾上腺素联合直肠吲哚美辛的效果优于单独使用吲哚美辛。
我们进行了一项比较有效性、多中心、双盲、随机试验，比较了单独使用直肠吲哚美辛与直肠吲哚美辛联合局部喷洒肾上腺素预防高危患者 PEP 的效果。主要结局是 PEP 的发生率，次要结局是 PEP 的严重程度。使用双侧 Fisher 确切检验分析吲哚美辛组与联合组 PEP 患者的比例差异。
共纳入 960 例患者（平均年龄 52.33 ± 14.96 岁；551 例[57.4%]为女性），并随机分为两组，其中 959 例完成了随访。两组的基线人口统计学和临床特征相似。年龄<50 岁的女性（25.4%）和困难插管（84.9%）是最常见的 PEP 危险因素。吲哚美辛组 PEP 的发生率为 6.4%（482 例），联合组为 6.7%（477 例）（P = 0.87）。吲哚美辛组和联合组分别有 5 例（12%）和 7 例（16%）患者发生严重 PEP（P = 0.88）。总死亡率为 0.6%，与主要结局无关。
在高危患者中，与单独使用直肠吲哚美辛相比，直肠吲哚美辛联合局部喷洒肾上腺素并不能降低 PEP 的发生率；https://clinicaltrials.gov/ct2/show/NCT02116309。
