Results of the Tokyo Trial of Prevention of Post-ERCP Pancreatitis with Risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial

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• 作者：Rie Uchino ; Hiroyuki Isayama ; Takeshi Tsujino ; Naoki Sasahira ; Yukiko Ito ; Saburo Matsubara ; Naminatsu Takahara ; Toshihiko Arizumi ; Nobuo Toda ; Dai Mohri ; Osamu Togawa ; Hiroshi Yagioka ; Yoshitsugu Yanagihara ; Katsuyoshi Nakajima ; Dai Akiyama ; Tsuyoshi Hamada ; Koji Miyabayashi ; Suguru Mizuno ; Kazumichi Kawakubo ; Hirofumi Kogure ; et al.
• 关键词：5-HT ; 5-hydroxytryptamine ; p-amylase ; pancreatic amylase ; PEP ; post-ERCP pancreatitis
• 刊名：Gastrointestinal Endoscopy
• 出版年：December, 2013
• 年：2013
• 卷：78
• 期：6
• 页码：842-850
• 全文大小：745 K

文摘

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Background

Our previous study suggested that a combination of ulinastatin and risperidone reduced post-ERCP pancreatitis (PEP) compared with ulinastatin alone.

Objective

The aim of this study was to evaluate the efficacy of risperidone alone for prevention of PEP.

Design

A multicenter, randomized, placebo-controlled, double-blind clinical trial.

Setting

Two academic hospitals and 5 referral hospitals in Tokyo and Saitama, Japan.

Patients

Patients undergoing therapeutic or interventional-diagnostic ERCP.

Intervention

The patients were randomized to receive 2 mg of oral risperidone or oral placebo at 0.5 to 2 hours before ERCP.

Main Outcome Measurements

The primary endpoint was the incidence of PEP. Secondary endpoints were the聽incidence of hyperenzymemia and enzyme levels (amylase, pancreatic amylase, lipase). Risk factors for PEP were evaluated.

Results

We initially enrolled 500 patients in the study (250 in the risperidone group and 250 in the placebo group), but 17 (11 in the risperidone and 6 in the placebo group) were excluded after randomization. PEP developed in 24聽patients (10.0%) in the risperidone group and 21 patients (8.6%) in the placebo group (P聽= .587). Serum amylase levels at 3 hours after ERCP were lower in the risperidone group (P聽= .007 in a single test of hypothesis, significance removed by Bonferroni correction for multiple testing). In multivariate analysis, a small papilla of Vater, total procedure time聽鈮?0 minutes, and stenosis of the intrahepatic duct were significantly associated with PEP.

Limitations

Multiplicity of study centers and a relatively wide time range of drug administration time.

Conclusion

Risperidone did not show a benefit in prevention of PEP in this trial. (Clinical trial registration number: .)