本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02356-5

摘要内容如下：

背景

建议对高危患者进行内镜逆行胰胆管造影术（ERCP）后，联合应用吲哚美辛直肠给药和放置预防性胰腺支架，以预防胰腺炎。初步证据表明，吲哚美辛的使用可能会消除或大大减少支架置入术的需要，这是一种技术复杂、昂贵且可能有害的干预措施。

方法

在美国和加拿大的20个转诊中心进行的这项随机、非劣效性试验中，ERCP术后胰腺炎高危患者（年龄≥18岁）被随机（1:1）分配接受直肠吲哚美辛单独治疗或吲哚美辛联合预防性胰腺支架治疗。患者、治疗临床医生和结果评估者对研究组分配不知情。主要转归是ERCP术后胰腺炎。要宣布非劣效性，ERCP术后胰腺炎差异的双侧95%CI上限（单用吲哚美辛减去吲哚美辛加支架）在意向治疗人群和符合方案人群中必须小于5%（非劣效性界值）。该试验已在ClinicalTrials.gov（NCT02476279）上注册，并且已经完成。

调查结果

在2015年9月17日至2023年1月25日期间，共有1950名患者被随机分配。单纯吲哚美辛组975例患者中有145例（14.9%）发生ERCP术后胰腺炎，吲哚美辛联合支架组975例患者中有110例（11.3%）发生ERCP术后胰腺炎（风险差异3.6%；95%可信区间为0.6~6.6；非劣效性P=0.18）。对两组间风险差异的事后意向治疗分析显示，单独使用吲哚美辛不如吲哚美辛联合预防性支架（P=0.011）。支架置入术的相对益处在研究亚组中基本一致，但在胰腺炎高危患者中更为显著。安全性结果（严重不良事件、重症监护室入院和住院时间）在两组之间没有差异。

解释

在预防高危患者ERCP术后胰腺炎方面，单独使用吲哚美辛的策略不如吲哚美辛联合预防性胰腺支架置入的策略有效。根据临床实践指南，这些结果支持高危患者在直肠给予吲哚美辛的基础上预防性放置胰腺支架。

英文原文如下：

Abstracts

BACKGROUND  The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.

METHODS  In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete.

FINDINGS  Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups.

INTERPRETATION  For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines.

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