Background: 

Endoscopic retrograde cholangiopancreatography (ERCP) has an important role in the treatment of pancreaticobiliary disorders.

Goals: 

Considering the high prevalence and importance of postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) and the controversial findings, we aimed to determine the effect of adding intravenous somatostatin to rectal indomethacin on the incidence of PEP in high-risk patients.

Study: 

In this prospective study, 530 patients underwent ERCP during March 2018 and February 2019. Patients were randomized into 2 groups. The intervention group received a bolus injection of 250 μg somatostatin followed by an infusion of 500 μg of somatostatin for 2 hours. In both groups, 100 mg of pre-ERCP suppository indomethacin was administrated. All patients were screened for PEP symptoms and signs for 24 hours after ERCP (Iranian Registry of Clinical Trials code: IRCT20080921001264N11).

Results: 

A total of 376 patients were finally analyzed. PEP was the most common adverse event with 50 (13.2%) episodes, including 21 (5.5%) mild, 23 (6.1%) moderate, and 6 (1.2%) severe. The rate of PEP was 15.2% in the control group and 11.4% in the intervention group (P=0.666). The incidence of post-ERCP hyperamylasemia was 21.7% in the control group and 18.2% in the intervention group (P=0.395). No death occurred.

Conclusions: 

In this study administration of somatostatin plus indomethacin could safely reduce the rate of post-ERCP hyperamylasemia and PEP in the intervention group compared with the control group, but the differences were not significant. Further studies with larger sample sizes are required.

中文翻译：

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直肠吲哚美辛静脉注射生长抑素对高危患者内镜逆行胰胆管造影（ERCP）后胰腺炎的影响：一项双盲随机安慰剂对照临床试验

背景： 

内镜逆行胰胆管造影术 (ERCP) 在胰胆疾病的治疗中具有重要作用。

目标： 

考虑到内镜下逆行胰胆管造影后胰腺炎 (PEP) 的高患病率和重要性以及有争议的发现，我们旨在确定在直肠吲哚美辛中加入静脉生长抑素对高危患者 PEP 发生率的影响。

学习： 

在这项前瞻性研究中，530 名患者在 2018 年 3 月和 2019 年 2 月期间接受了 ERCP。患者被随机分为两组。干预组接受 250 μg 生长抑素的推注，随后输注 500 μg 生长抑素 2 小时。两组均给予100 mg ERCP 前栓剂消炎痛。在 ERCP（伊朗临床试验登记处代码：IRCT20080921001264N11）后 24 小时内，对所有患者进行了 PEP 症状和体征筛查。

结果： 

最终共分析了 376 名患者。PEP 是最常见的不良事件，有 50 起 (13.2%) 事件，包括 21 起 (5.5%) 轻度事件、23 起 (6.1%) 中度事件和 6 起 (1.2%) 重度事件。对照组PEP发生率为15.2%，干预组为11.4%（P =0.666）。ERCP术后高淀粉酶血症的发生率在对照组和干预组分别为21.7%和18.2%（P =0.395）。没有死亡发生。

结论： 

在这项研究中，与对照组相比，生长抑素加吲哚美辛的给药可以安全地降低干预组 ERCP 后高淀粉酶血症和 PEP 的发生率，但差异不显着。需要更大样本量的进一步研究。