Ishiwatari Hirotoshi, Urata Takahiro, Yasuda Ichiro, Matsusaki Shimpei, Hisai Hiroyuki, Kawakami Hiroshi, Ono Michihiro, Iwashita Takuji, Doi Shinpei, Kawakubo Kazumichi, Hayashi Tsuyoshi, Sonoda Tomoko, Sakamoto Naoya, Kato Junji
Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
Department of Gastroenterology, Japanese Red Cross Kumamoto Hospital, 1-1-2, Nagamineminami, Higashiku, Kumamoto, 861-8520, Japan.
Dig Dis Sci. 2016 Nov;61(11):3292-3301. doi: 10.1007/s10620-016-4251-x. Epub 2016 Jul 22.
Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a serious complication. Rectal diclofenac (100 mg) has been shown to reduce the incidence of pancreatitis; however, this dosage form is unavailable in several countries.
We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial.
Patients undergoing a first ERCP in seven high-volume centers between July 2012 and August 2014 were considered eligible. Participants were administered oral diclofenac (50 mg) or placebo before and after ERCP. The primary endpoint was the incidence of pancreatitis. A subgroup analysis was performed for patients at high or low risk of pancreatitis. Secondary endpoints were pancreatic enzyme levels (amylase and lipase).
We initially enrolled 430 patients (216 in the diclofenac and 214 in the placebo group), and 23 were excluded after randomization. The overall incidence of pancreatitis was 9.8 % (20/205) and 9.4 % (19/202) in the diclofenac and placebo groups, respectively (p = 0.90). The incidence of pancreatitis was 20.3 % (13/64) and 21.3 % (13/61) in patients at high risk of pancreatitis (p = 0.78) and 5.0 % (7/141) and 4.3 % (6/141) in patients at low risk of pancreatitis in the diclofenac and placebo groups (p = 0.94), respectively. There were no significant differences in serum amylase and lipase levels between the two groups before and 24 h after ERCP.
Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis.
UMIN000008109.
内镜逆行胰胆管造影术（ERCP）后胰腺炎是一种严重的并发症。直肠用双氯芬酸（100毫克）已被证明可降低胰腺炎的发生率；然而，这种剂型在几个国家无法获得。
我们旨在通过一项多中心、随机、前瞻性、安慰剂对照、双盲试验，研究口服双氯芬酸对ERCP术后胰腺炎的预防作用。
2012年7月至2014年8月期间，在7个高容量中心接受首次ERCP的患者被认为符合条件。参与者在ERCP前后分别给予口服双氯芬酸（50毫克）或安慰剂。主要终点是胰腺炎的发生率。对胰腺炎高风险或低风险患者进行亚组分析。次要终点是胰腺酶水平（淀粉酶和脂肪酶）。
我们最初纳入了430例患者（双氯芬酸组216例，安慰剂组214例），随机分组后排除了23例。双氯芬酸组和安慰剂组胰腺炎的总体发生率分别为9.8%（20/205）和9.4%（19/202）（p = 0.90）。胰腺炎高风险患者中，双氯芬酸组和安慰剂组的发生率分别为20.3%（13/64）和21.3%（13/61）（p = 0.78）；胰腺炎低风险患者中，双氯芬酸组和安慰剂组的发生率分别为5.0%（7/141）和4.3%（6/141）（p = 0.94）。ERCP前及术后24小时，两组血清淀粉酶和脂肪酶水平无显著差异。
ERCP前后口服双氯芬酸对预防胰腺炎无益处。
UMIN000008109。
