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Low‐dose rectal diclofenac does not prevent post‐ERCP pancreatitis in low‐ or high‐risk patients
Author(s) -
Katoh Takao,
Kawashima Kousaku,
Fukuba Nobuhiko,
Masuda Shigeto,
Kobatake Hiroko,
Masaki Kousaku,
Araki Yasuhiro,
Kawano Koichiro,
Nishi Katsuhisa,
Takenaka Mamoru,
Ishihara Shunji,
Kinoshita Yoshikazu
Publication year - 2020
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.14948
Subject(s) - medicine , diclofenac , clinical endpoint , pancreatitis , randomized controlled trial , endoscopic retrograde cholangiopancreatography , randomization , adverse effect , surgery , rectal administration , incidence (geometry) , relative risk , anesthesia , gastroenterology , confidence interval , physics , optics
Background and Aim The most common adverse event following an endoscopic retrograde cholangiopancreatography (ERCP) procedure is post‐ERCP pancreatitis (PEP). Rectal nonsteroidal anti‐inflammatory drug (NSAID) administration has shown promise to reduce the risk of PEP in high‐risk patients. However, in contrast to high‐risk patients, the role of NSAID administration in patients with low risk remains controversial. Methods We performed a prospective, single‐center, single‐blinded, two‐arm parallel group, randomized controlled trial to clarify the efficacy of low dose (50 mg) rectal NSAID administration for preventing PEP in at‐risk patients. Patients scheduled to undergo ERCP were randomized into two groups, those with and without rectal administration of diclofenac. Patients in the diclofenac group received 50 mg of rectal diclofenac 30 min before undergoing ERCP. The primary endpoint was rate of PEP. Results A total of 303 were randomized into the study groups. Four patients declined participation following randomization, and another two were withdrawn. As a result, a total of 147 patients were assigned to the diclofenac group and 150 to the control group. The baseline and procedural characteristics were similar in both groups. The primary endpoint of PEP occurrence was seen in 13 of 297 patients (4.4%), including eight (5.4%) in the diclofenac group and five (3.3%) in the control group ( P = 0.286). Additionally, those results were not significantly different when patients were classified as low or high risk. Conclusions Prophylactic low‐dose rectal diclofenac did not reduce the incidence of PEP following ERCP in patients classified as low or high risk.