Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial

Fogel, Evan L.; Lehman, Glen A.; Tarnasky, Paul R.; Coté, Gregory A.; Schmidt, Steven M.; Waljee, Akbar K.; Higgins, Peter; Watkins, James L.; Sherman, Stuart; Kwon, Richard S.; Elta, Grace H.; Easler, Jeffrey J.; Pleskow, Douglas K.; Scheiman, James M.; Hajj, Ihab I. El; Guda, Nalini M.; Gromski, Mark A.; McHenry, Lee; Arol, Seena; Korsnes, Sheryl J.; Suarez, Alejandro L.; Spitzer, Rebecca L.; Miller, Marilyn; Hofbauer, Maria; Elmunzer, B. Joseph

doi:10.1016/s2468-1253(19)30337-1

Cited by 27 publications

(20 citation statements)

References 37 publications

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“…Recently, a large scale multicenter randomized trial was conducted to compare the efficacy of high‐dose regimen (200 mg) and standard‐dose regimen (100 mg) of rectal NSAIDs on the frequency of PEP, and the high‐dose regimen did not appear to offer any advantage over the standard‐dose regimen 17 . This result suggests that the effect of NSAIDs in preventing PEP may not be dose dependent, and if low dose rectal NSAIDs can prevent PEP as well as the standard dose, it is likely to be safer than a standard dose.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of low dose rectal diclofenac for preventing post‐endoscopic retrograde cholangiopancreatography pancreatitis: Propensity score‐matched analysis

Tomoda

Kato

Miyamoto

et al. 2020

Digestive Endoscopy

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Background: Acute pancreatitis is a major adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) decreases the incidence of post-ERCP pancreatitis (PEP). However, the efficacy of low dose rectal NSAIDs for preventing PEP remains controversial. Methods:We performed a retrospective study of 301 patients with native papilla and a body weight of <50 kg who underwent ERCP between September 2010 and October 2019. After July 2016, a 25 mg dose of rectal diclofenac was routinely administered within 15 min before ERCP (NSAIDs group, n = 72) and the control group (n = 229) consisted of patients undergoing ERCP before this date without treatment. We compared the incidence of PEP between the two groups using propensity score matching.Results: A total of 66 pairs of patients in each group were selected. The patients and procedural-related factors were similar in both groups. In total, 15 patients (11.4%) developed PEP: 12.1% (8/66) in the NSAIDs group and 10.6% (7/66) in the control group (Odds ratio (OR) 1.2; 95% confidence interval (CI) 0.4-3.5; P = 0.78). There was no significant difference in incidence of other adverse events related to ERCP between the two groups.Conclusions: Prophylactic administration of a 25 mg dose of rectal diclofenac did not reduce the incidence of PEP in patients with a native papilla and a body weight of <50 kg in this study and a certain dose of rectal NSAIDs, such as a 100-mg dose, should be administered regardless of body weight to prevent PEP.

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Section: Discussionmentioning

confidence: 99%

Efficacy of low dose rectal diclofenac for preventing post‐endoscopic retrograde cholangiopancreatography pancreatitis: Propensity score‐matched analysis

Tomoda

Kato

Miyamoto

et al. 2020

Digestive Endoscopy

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“…There was no significant difference in the frequency of PEP between the 25 and 50 mg groups as well (9% [2/22] vs. 0% [0/29], p = 0.101). Considering a lower mean body weight of this Japanese population, low-dose 50 mg of rectal NSAID Recently, two randomized clinical trials with dose escalation of rectal indomethacin to 200 mg were reported [38,43]. It was hypothesized that a higher dose might be superior to the existing standard 100 mg dose in PEP prevention.…”

Section: Dose Of Rectal Nsaids: Low Vs Single Vs Double Dosementioning

confidence: 99%

“…It was hypothesized that a higher dose might be superior to the existing standard 100 mg dose in PEP prevention. Split dose administration was performed in both studies: to minimize the potential for adverse events of the higher dose in one study [38], and to potentially lead to a higher peak serum concentration and a more sustained impact on the inflammatory cascade in the second study [43]. In the first trial from Taiwan, which evaluated predominantly average-risk patients, the double dose group received an initial 100 mg about 4 to 5 hours before ERCP and an additional 100 mg immediately after ERCP [38].…”

Section: Dose Of Rectal Nsaids: Low Vs Single Vs Double Dosementioning

confidence: 99%

“…In the first trial from Taiwan, which evaluated predominantly average-risk patients, the double dose group received an initial 100 mg about 4 to 5 hours before ERCP and an additional 100 mg immediately after ERCP [38]. In the second trial, a multicenter trial from USA which evaluated only patients who were considered to be at high-risk for the development of PEP, the high-dose group received an initial 150 mg at the end of the ERCP, followed by an additional 50 mg 4 hours after the procedure [43]. In both studies, dose escalation of rectal indomethacin to 200 mg did not confer any additional reduction in PEP.…”

Section: Dose Of Rectal Nsaids: Low Vs Single Vs Double Dosementioning

confidence: 99%

“…Additional study is needed to further lower PEP rates. In addition to studies evaluating a higher dose of the NSAID (i.e., double dose) as described above [38,43], trials with combination rectal NSAIDS and other strategies or pharmacologic agents including intravenous fluids [44][45][46], intravenous somatostatin [47], sublingual isosorbide dinitrate [48,49], and intraduodenal epinephrine spray [50][51][52] have been reported (Table 2).…”

Section: Combination With Other Pharmacological Agentsmentioning

confidence: 99%

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Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis with rectal non-steroidal anti-inflammatory drugs

Park

Fogel

et al. 2020

Korean J Intern Med

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Acute pancreatitis is the most common and feared adverse event associated with performance of endoscopic retrograde cholangiopancreatography (ERCP). Unremitting effort has been made for over 40 years to minimize the frequency and severity of this complication. Recently, the use of rectal non-steroidal anti-inflammatory drugs (NSAIDs) have opened a new era for its prevention. This review focuses on the role of NSAIDs in pancreatitis, the pharmacokinetics of these agents, and summarizes the results of clinical trials with rectal NSAIDs alone and combination regimens in the prevention of post-ERCP pancreatitis.

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Rectal indomethacin and diclofenac are equally efficient in preventing pancreatitis following endoscopic retrograde cholangiopancreatography in average‐risk patients

Shen

et al. 2021

JGH Open

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Rectal indomethacin and diclofenac are promising drugs for prevention of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, their prophylactic effect on PEP in average‐risk patients remains controversial. We performed a systematic review and meta‐analysis to assess the efficacy and safety of rectal indomethacin and diclofenac in average‐risk patients, and to indirectly compare the prophylactic effect of the two drugs. A comprehensive search of the PubMed, EMBASE, and Cochrane Library databases was performed to identify randomized controlled trials (RCTs) on rectal indomethacin or diclofenac for prophylaxis against PEP. Fixed‐ and random‐effects models weighted by the Mantel–Haenszel method were used for direct comparisons. The adjusted indirect treatment comparison method was used to indirectly compare the efficacy of indomethacin and diclofenac. A total of 10 RCTs, including 2928 patients, met our inclusion criteria. No significant publication bias was identified. Pooled estimates showed that rectal indomethacin and diclofenac were associated with a significant reduction in the overall risk of PEP compared with control intervention [relative risk (RR) = 0.62; 95% confidence interval (CI): 0.46–0.83] in average‐risk patients. Subgroup analyses showed that both rectal indomethacin (RR = 0.67; 95% CI: 0.49–0.94) and diclofenac (RR = 0.42; 95% CI: 0.23–0.75) were effective in the prevention of PEP. Indirect comparison showed no significant difference between the effectiveness of the two drugs in the prevention of PEP (RR = 1.607; 95% CI: 0.824–3.136). The updated meta‐analysis suggests that both drugs provide equivalent protection against PEP in average‐risk patients.

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Rectal indometacin dose escalation for prevention of pancreatitis after endoscopic retrograde cholangiopancreatography in high-risk patients: a double-blind, randomised controlled trial

Cited by 27 publications

References 37 publications

Efficacy of low dose rectal diclofenac for preventing post‐endoscopic retrograde cholangiopancreatography pancreatitis: Propensity score‐matched analysis

Efficacy of low dose rectal diclofenac for preventing post‐endoscopic retrograde cholangiopancreatography pancreatitis: Propensity score‐matched analysis

Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis with rectal non-steroidal anti-inflammatory drugs

Rectal indomethacin and diclofenac are equally efficient in preventing pancreatitis following endoscopic retrograde cholangiopancreatography in average‐risk patients

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