Concepción-Martín Mar, Gómez-Oliva Cristina, Juanes Ana, Díez Xavier, Prieto-Alhambra Daniel, Torras Xavier, Sainz Sergio, Villanueva Cándido, Farre Antoni, Guarner-Argente Carlos, Guarner Carlos
Gastroenterology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Pharmacology Department, Hospital de la Santa Creu i Sant Pau, Institut de Reçerca - IIB Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
Endoscopy. 2014 Oct;46(10):851-6. doi: 10.1055/s-0034-1377306. Epub 2014 Jun 30.
Meta-analyses suggest that an intravenous bolus or a high dose continuous infusion of somatostatin reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). Clinical guidelines, however, do not recommend this prophylaxis. The aim of this randomized, double-blind clinical trial was to evaluate the effect of somatostatin on the incidence of post-ERCP pancreatitis.
Patients undergoing ERCP at a single center were randomized to either intravenous bolus of somatostatin followed by a short (4-hour) continuous infusion, or to a similar placebo regimen. The primary outcome was post-ERCP pancreatitis, defined as abdominal pain with an amylase level at least three times higher than the upper limit of normality 24 hours after the ERCP and requiring admission for at least 2 days.
A total of 510 patients were enrolled (255 patients per group) and all completed follow-up. The main indications for ERCP were choledocholithiasis (62 %), and biliary malignant stricture (31 %). Post-ERCP pancreatitis occurred in 19 patients (7.5 %) in the somatostatin group and 17 patients (6.7 %) in the placebo group (relative risk [RR] 1.12, 95 % confidence interval [95 %CI] 0.59 - 2.1; P = 0.73). The number of cases of moderate or severe acute pancreatitis was similar in the somatostatin (2.4 %) and the placebo (3.5 %) groups (RR 0.67, 95 %CI 0.24 - 1.85, P = 0.43). No side effects were observed related to the use of somatostatin.
Administration of an intravenous bolus of somatostatin followed by a short continuous infusion does not reduce the incidence of post-ERCP pancreatitis. Clinical Trials.gov number: NCT01060826.
荟萃分析表明，静脉推注或大剂量持续输注生长抑素可降低内镜逆行胰胆管造影术（ERCP）后急性胰腺炎的发生率。然而，临床指南并不推荐这种预防措施。这项随机双盲临床试验的目的是评估生长抑素对ERCP术后胰腺炎发生率的影响。
在单一中心接受ERCP的患者被随机分为两组，一组静脉推注生长抑素后进行短时间（4小时）持续输注，另一组接受类似的安慰剂方案。主要结局是ERCP术后胰腺炎，定义为ERCP术后24小时出现腹痛且淀粉酶水平至少高于正常上限三倍，并需要住院至少2天。
共纳入510例患者（每组255例），所有患者均完成随访。ERCP的主要适应证为胆总管结石（62%）和胆道恶性狭窄（31%）。生长抑素组有19例患者（7.5%）发生ERCP术后胰腺炎，安慰剂组有17例患者（6.7%）发生（相对危险度[RR]1.12，95%置信区间[95%CI]0.59 - 2.1；P = 0.73）。生长抑素组（2.4%）和安慰剂组（3.5%）中、重度急性胰腺炎的病例数相似（RR 0.67，95%CI 0.24 - 1.85，P = 0.43）。未观察到与使用生长抑素相关的副作用。
静脉推注生长抑素后进行短时间持续输注并不能降低ERCP术后胰腺炎的发生率。临床试验注册号：NCT01060826。
