start-ver=1.4
cd-journal=joma
no-vol=156
cd-vols=
no-issue=6
article-no=
start-page=1753
end-page=1760
dt-received=
dt-revised=
dt-accepted=
dt-pub-year=2019
dt-pub=20190531
dt-online=
en-article=
kn-article=
en-subject=
kn-subject=
en-title=
kn-title=Combination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
en-subtitle=
kn-subtitle=
en-abstract=
kn-abstract=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.
METHODS:
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.
RESULTS:
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.
CONCLUSIONS:
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.
en-copyright=
kn-copyright=
en-aut-name=TomodaTakeshi
en-aut-sei=Tomoda
en-aut-mei=Takeshi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=1
ORCID=
en-aut-name=KatoHironari
en-aut-sei=Kato
en-aut-mei=Hironari
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=2
ORCID=
en-aut-name=UekiToru
en-aut-sei=Ueki
en-aut-mei=Toru
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=3
ORCID=
en-aut-name=AkimotoYutaka
en-aut-sei=Akimoto
en-aut-mei=Yutaka
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=4
ORCID=
en-aut-name=HataHidenori
en-aut-sei=Hata
en-aut-mei=Hidenori
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=5
ORCID=
en-aut-name=FujiiMasakuni
en-aut-sei=Fujii
en-aut-mei=Masakuni
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=6
ORCID=
en-aut-name=Harada Ryo
en-aut-sei=Harada
en-aut-mei= Ryo
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=7
ORCID=
en-aut-name=OgawaTsuneyoshi
en-aut-sei=Ogawa
en-aut-mei=Tsuneyoshi
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=8
ORCID=
en-aut-name=Wato Masaki
en-aut-sei=Wato
en-aut-mei= Masaki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=9
ORCID=
en-aut-name=TakataniMasahiro
en-aut-sei=Takatani
en-aut-mei=Masahiro
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=10
ORCID=
en-aut-name=MatsubaraMinoru
en-aut-sei=Matsubara
en-aut-mei=Minoru
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=11
ORCID=
en-aut-name=KawaiYoshinari
en-aut-sei=Kawai
en-aut-mei=Yoshinari
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=12
ORCID=
en-aut-name=OkadaHiroyuki
en-aut-sei=Okada
en-aut-mei=Hiroyuki
kn-aut-name=
kn-aut-sei=
kn-aut-mei=
aut-affil-num=13
ORCID=
affil-num=1
en-affil=epartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=2
en-affil=Department of Gastroenterology and HepatologyOkayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
affil-num=3
en-affil=Department of Internal Medicine, Fukuyama City Hospital
kn-affil=
affil-num=4
en-affil=Department of Gastroenterology, Iwakuni Clinical Center
kn-affil=
affil-num=5
en-affil=Department of Gastroenterology, Mitoyo General Hospital
kn-affil=
affil-num=6
en-affil=Department of Internal Medicine, Okayama Saiseikai General Hospital
kn-affil=
affil-num=7
en-affil=Department of Gastroenterology, Japanese Red Cross Okayama Hospital
kn-affil=
affil-num=8
en-affil=Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital
kn-affil=
affil-num=9
en-affil=Department of Gastroenterology, Kagawa Prefectural Central Hospital
kn-affil=
affil-num=10
en-affil=Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital
kn-affil=
affil-num=11
en-affil=Department of Internal Medicine, Sumitomo Besshi Hospital
kn-affil=
affil-num=12
en-affil=Department of Gastroenterology, Onomichi Municipal Hospital
kn-affil=
affil-num=13
en-affil=epartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
kn-affil=
en-keyword=Drug
kn-keyword=Drug
en-keyword=Inflammation
kn-keyword=Inflammation
en-keyword=Pancreas
kn-keyword=Pancreas
en-keyword=Smooth-Muscle Relaxant
kn-keyword=Smooth-Muscle Relaxant
END