Hirotoshi Ishiwatari1, Takahiro Urata2, Ichiro Yasuda3, Shimpei Matsusaki4, Hiroyuki Hisai5, Hiroshi Kawakami6, Michihiro Ono7, Takuji Iwashita8, Shinpei Doi3, Kazumichi Kawakubo9, Tsuyoshi Hayashi7, Tomoko Sonoda10, Naoya Sakamoto9, Junji Kato7. 1. Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. ishihiro481019@gmail.com. 2. Department of Gastroenterology, Japanese Red Cross Kumamoto Hospital, 1-1-2, Nagamineminami, Higashiku, Kumamoto, 861-8520, Japan. 3. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan. 4. Department of Gastroenterology, Suzuka General Hospital, 53-1275, Uyamanohana, Yasuzukacho, Suzuka, Mie, 513-8630, Japan. 5. Department of Gastroenterology, Japanese Red Cross Date Hospital, 81, Suenagacho, Date, Hokkaido, 052-8511, Japan. 6. Department of Gastroenterology and Hepatology, Center for Digestive Disease, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, 889-1692, Japan. 7. Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. 8. First Department of Internal Medicine, Gifu University Hospital, 1-1, Yanagito, Gifu, Gifu, 501-1194, Japan. 9. Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan. 10. Department of Public Health, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
Abstract
BACKGROUND: 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. AIMS: We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial. METHODS: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). RESULTS: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. CONCLUSIONS: Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis. CLINICAL TRIALS REGISTRY NO: UMIN000008109.
RCT Entities:
BACKGROUND: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. AIMS: We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial. METHODS: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). RESULTS: 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. CONCLUSIONS: Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis. CLINICAL TRIALS REGISTRY NO: UMIN000008109.
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