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Tomoda, Takeshi epartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Kato, Hironari Department of Gastroenterology and HepatologyOkayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Kaken ID researchmap
Ueki, Toru Department of Internal Medicine, Fukuyama City Hospital
Akimoto, Yutaka Department of Gastroenterology, Iwakuni Clinical Center
Hata, Hidenori Department of Gastroenterology, Mitoyo General Hospital
Fujii, Masakuni Department of Internal Medicine, Okayama Saiseikai General Hospital
Harada, Ryo Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Ogawa, Tsuneyoshi Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital
Wato, Masaki Department of Gastroenterology, Kagawa Prefectural Central Hospital
Takatani, Masahiro Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital
Matsubara, Minoru Department of Internal Medicine, Sumitomo Besshi Hospital
Kawai, Yoshinari Department of Gastroenterology, Onomichi Municipal Hospital
BACKGROUND & AIMS:
Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). Little is known about the combined effects of sublingual nitrate and NSAIDs. We performed a randomized trial to assess whether the combination of NSAIDs and sublingual nitrate is more effective than NSAIDs alone in preventing PEP.
In a prospective superiority trial, eligible patients underwent ERCP at 12 endoscopic units in Japan, from March 2015 through May 2018. Patients were randomly assigned to groups given diclofenac suppositories (50 mg) within 15 minutes after the endoscopic procedure alone (diclofenac-alone group, n = 442) or in combination with sublingual isosorbide dinitrate (5 mg) 5 minutes before the endoscopic procedure (combination group, n = 444). The primary endpoint was the occurrence of PEP.
PEP developed in 25 patients in the combination group (5.6%), and in 42 patients in the diclofenac-alone group (9.5%) (relative risk 0.59; 95% confidence interval 0.37-0.95; P = .03). Moderate to severe pancreatitis developed in 4 patients (0.9%) in the combination group, and 10 patients (2.3%) in the diclofenac-alone group (relative risk 0.12; 95% confidence interval 0.13-1.26; P = .12). There was no serious adverse event related to the additional administration of sublingual nitrate.
In a randomized controlled trial, we found that prophylaxis with rectal diclofenac and sublingual nitrate significantly reduces the overall incidence of PEP compared with diclofenac suppository alone. ClinicalTrials.gov, no: UMIN 000016274.
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|Web of Science KeyUT|
Takeshi Tomoda, Hironari Kato, Toru Ueki, Yutaka Akimoto, Hidenori Hata, Masakuni Fujii, Ryo Harada, Tsuneyoshi Ogawa, Masaki Wato, Masahiro Takatani, Minoru Matsubara, Yoshinari Kawai, Hiroyuki Okada, Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography, Gastroenterology, Volume 156, Issue 6, 2019, Pages 1753-1760.e1, ISSN 0016-5085, https://doi.org/10.1053/j.gastro.2019.01.267.
|Open Access (Publisher)||
|Open Archive (publisher)||