Original ResearchFull Report: Clinical—PancreasCombination of Diclofenac and Sublingual Nitrates Is Superior to Diclofenac Alone in Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
Section snippets
Study Design
The study was a 2-arm, multicenter, prospective, randomized, superiority unblinded trial to evaluate the combined effect of nitrate and diclofenac in the prevention of PEP, in comparison with the efficacy of diclofenac alone. The study was conducted between March 2015 and May 2018 at 12 centers in Japan; more than 200 ERCPs per year were performed in each center. A total of 900 eligible patients were randomly assigned to receive a 50-mg diclofenac suppository either alone or in combination with
Patients
Between March 2015 and May 2018, 10,188 patients were scheduled to undergo ERCP and assessed for eligibility across 12 centers. After screening, 9288 patients met the exclusion criteria and 44 declined to participate. Patients were deemed to be inappropriate for trial when their health was unstable due severe cholangitis (n = 55), advanced cancer (n = 26), severe comorbidity (n = 15), decompensated cirrhosis (n = 11), or advanced age (> 85 years) (n = 36). The remaining 900 patients were
Discussion
Rectal administration of NSAIDs has been widely used for the prevention of PEP, and has been recommended to be administered in all patients without contraindications in the European Society of Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic Surgery guidelines.11, 12
In this multicenter, randomized controlled trial, we found that the combination therapy with diclofenac and sublingual nitrate significantly reduced the incidence of PEP as compared with that with the use
Acknowledgments
The authors thank the staff of the Department of Clinical Data Management, Center for Innovative Clinical Medicine of Okayama University Hospital for their assistance in relation to the case registration system.
We also thank Koichiro Tsutsumi, Shigeru Horiguchi, Kazuyuki Matsumoto, Daisuke Uchida, Shinichiro Muro, Saimon Takata, Shuntaro Yabe, Sho Mizukawa, and Yousuke Saragai of Okayama University Hospital for their help in accomplishing this study.
Author contributions: TT and HK took part in
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Cited by (35)
Machine learning for the prediction of post-ERCP pancreatitis risk: A proof-of-concept study
2023, Digestive and Liver DiseaseCitation Excerpt :Acute pancreatitis (AP) is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), with an incidence of 3.5–9.7%, that can reach 14.7% in high risk patients [1,2]. Several patient-related and procedural-related risk and protective factors for Post-ERCP Pancreatitis (PEP) have been reported [1–3], while periprocedural administration of non-steroidal anti-inflammatory drugs (NSAIDs) and Ringer solution are commonly used to decrease PEP risk [4–6]. Despite knowledge of these factors, PEP is often unpredictable and new tools to predict this event are sorely needed.
Network meta-analysis of prophylactic pancreatic stents and non-steroidal anti-inflammatory drugs in the prevention of moderate-to-severe post-ERCP pancreatitis
2021, PancreatologyCitation Excerpt :All computations were performed using the R (V. 3.5.2) package gemtc (V. 0.8–2) along with the Markov Chain Monte Carlo engine JAGS (V. 3.4.0), package netmeta (V. 1.1–0), and STATA 16.0 (StataCorp LLC). After the literature search, we identified 29 full-text NSAID RCTs and 18 PPS RCTs that examined the effect of these methods in the prevention of PEP [14–60]. After a thorough analysis of these studies and evaluation of the provided data, 11 NSAID RCTs comprising 4296 patients and 10 PPS RCTs comprising 1239 patients were included in the final network meta-analysis.
Preventing Post-ERCP Pancreatitis
2023, Practical Gastroenterology
Conflicts of interest The authors disclose no conflicts.