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. 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 (), and is complete. 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. 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. US National Institutes of Health.

中文翻译：

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吲哚美辛联合或不联合预防性胰腺支架置入预防 ERCP 后胰腺炎：一项随机非劣效性试验

建议将直肠给予吲哚美辛和放置预防性胰腺支架相结合，以预防高危患者进行内镜逆行胰胆管造影（ERCP）后发生胰腺炎。初步证据表明，使用吲哚美辛可能会消除或大大减少支架置入的需要，这是一种技术复杂、成本高昂且可能有害的干预措施。在这项在美国和加拿大 20 个转诊中心进行的随机非劣效性试验中，ERCP 后胰腺炎高风险患者（年龄≥18 岁）被随机分配（1:1）接受单独直肠吲哚美辛治疗或联合治疗吲哚美辛加预防性胰腺支架。患者、治疗临床医生和结果评估人员对研究组分配情况不知情。主要结局是 ERCP 后胰腺炎。为了宣布非劣效性，ERCP 后胰腺炎（单独使用吲哚美辛减去吲哚美辛加支架）差异的双侧 95% CI 上限必须低于 5%（非劣效界）。意向治疗人群和符合方案的人群。本次试验已注册（），并已完成。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。单独使用吲哚美辛组的 975 名患者中有 145 名患者 (14·9%) 发生了 ERCP 后胰腺炎，而吲哚美辛联合支架组的 975 名患者中有 110 名患者 (11·3%) 发生了 ERCP 后胰腺炎（风险差异 3·6%；95% CI 0 ·6–6·6；p=0·18 表示非劣效性）。对组间风险差异的事后意向治疗分析表明，单独使用吲哚美辛优于吲哚美辛加预防性支架的组合（p=0·011）。支架置入的相对益处在各个研究亚组中总体一致，但在胰腺炎风险最高的患者中显得更为突出。安全性结果（严重不良事件、重症监护病房入住和住院时间）在各组之间没有差异。对于预防高危患者的 ERCP 术后胰腺炎，单独使用吲哚美辛策略不如吲哚美辛加预防性胰腺支架置入策略有效。这些结果支持根据临床实践指南，在高危患者中除直肠吲哚美辛外，还应预防性放置胰腺支架。美国国立卫生研究院。