Is High-Dose Nafamostat Mesilate Effective for the Prevention of Post-ERCP Pancreatitis, Especially in High-Risk Patients?

Park, Kee Tae; Kang, Dae Hwan; Choi, Cheol Woong; Cho, Mong; Park, Su Bum; Kim, Hyung Wook; Kim, Dong Uk; Chung, Chung Wook; Yoon, Ki Tae

doi:10.1097/mpa.0b013e31822116d5

Cited by 51 publications

(40 citation statements)

References 28 publications

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“…The NMA included 12 head‐to‐head trials and 87 placebo‐controlled trials. There were nine three‐arm RCTs that evaluated two different agents with placebo and seven RCTs that evaluated single agents at different dosages with placebo. There were 85 RCTs published in English, 5 in Chinese, 2 in Italian, 2 in Spanish, 2 in German, 1 in Hungarian, 1 in Korean and 1 in Japanese .…”

Section: Resultsmentioning

confidence: 99%

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Systematic review with network meta‐analysis: pharmacological prophylaxis against post‐ERCP pancreatitis

Akshintala

Hutfless

Colantuoni

et al. 2013

Aliment Pharmacol Ther

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SUMMARY BackgroundThe efficacy of many pharmacological agents for preventing post-ERCP pancreatitis (PEP) has been evaluated in randomised controlled trials (RCTs), but it is unclear which agent(s) should be used in clinical practice. Network meta-analyses of RCTs are used to simultaneously compare several agents to determine their relative efficacy and identify priority agents for comparison in future RCTs.

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Section: Resultsmentioning

confidence: 99%

“…Nafamostat is intravenously administered over an extended time period before, during and after ERCP. One study administered nafamostat for as long as 24 h . The primary limitation of antibiotics is microbial resistance, which is already a significant global health problem …”

Section: Discussionmentioning

confidence: 99%

Systematic review with network meta‐analysis: pharmacological prophylaxis against post‐ERCP pancreatitis

Akshintala

Hutfless

Colantuoni

et al. 2013

Aliment Pharmacol Ther

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“…Regarding gabexate mesylate and nafamostat, four meta‐analyses about the administration of gabexate mesylate demonstrated no positive effect on lowering the risk of PEP . As for nafamostat, a meta‐analysis pooled from five RCTs (total 2678 patients) revealed that nafamostat would lower the risk of PEP in low‐risk group and not in high‐risk group . Regarding nitroglycerin, two meta‐analyses including nine RCTs (total 2516 patients) recommended that sublingual route is more effective and the timing of dosing was variable, ranging from 5 to 60 minutes prior to ERCP .…”

Section: Preventionmentioning

confidence: 99%

“…39 As for nafamostat, a meta-analysis pooled from five RCTs (total 2678 patients) revealed that nafamostat would lower the risk of PEP in low-risk group and not in high-risk group. [40][41][42][43] Regarding nitroglycerin, two meta-analyses including nine RCTs (total 2516 patients) recommended that sublingual route is more effective and the timing of dosing was variable, ranging from 5 to 60 minutes prior to ERCP. 44,45 As for somatostatin, a meta-analysis including nine RCTs demonstrated no positive effect for preventing PEP.…”

Section: Pharmacologic Prophylaxismentioning

confidence: 99%

“…Inhibitor of protease activation Gabexate mesylate Nafamostat Yuhara et al 38 Choi et al 39 Park et al 40 Yoo et al 41 Kim et al 42 6 5 45 Bang et al 46 9 2 mg sublingual 5 min prior to ERCP 2 mg sublingual 5 min prior to ERCP Sublingual route is more effective, timing is variable Indeed hydration with lactated Ringer's solution + rectal indomethacin reduced the incidence of PEP and readmission rate. 55…”

Section: Hydrationmentioning

confidence: 99%

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Postendoscopic retrograde cholangiopancreatography pancreatitis

Shih

Hsu

Kuo

2019

The Kaohsiung J of Med Scie

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Endoscopic retrograde cholangiopancreatography (ERCP) has been a mainstay examination to clarify the biliary and pancreatic system. Not just diagnostic purpose, it could achieve therapeutic goal. Under the trend of more and more procedures about ERCP being interventional, the rate of adverse events after the procedure is increasing. Among them, post‐ERCP pancreatitis (PEP) is the most common and sometimes tremendous complication. This mini‐review will overview the PEP from definition, pathogenesis, and risk factors to prevention.

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Nafamostat Reduces the Incidence of post‐ERCP Pancreatitis: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

Horváth,

Kleiner,

Nagy

et al. 2023

Clin Pharma and Therapeutics

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Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). As the management of pancreatitis is limited, clinical approaches focus on the prevention of post‐ERCP pancreatitis (PEP). In theory, the serine protease inhibitor nafamostat can reduce circulating inflammatory mediators in pancreatitis. We aimed to investigate the effect of nafamostat in the prevention of PEP in this systematic review and meta‐analysis. The protocol for this review was registered in PROSPERO (CRD42022367988). We systematically searched 5 databases without any filters on September 26, 2022. The eligible population was adult patients undergoing ERCP. We compared the PEP preventive effect of nafamostat to placebo. The main outcome was the occurrence of PEP. We calculated the pooled odds ratios (ORs), mean differences, and corresponding 95% confidence intervals (95% CIs) and multilevel model. The risk of bias was assessed using the Rob2 tool. Seven randomized controlled trials involving 2,962 patients were eligible for inclusion. Nafamostat reduced the overall incidence rate of PEP (20 mg, OR: 0.50, 95% CI: 0.30–0.82 and 50 mg, OR: 0.48, 95% CI: 0.24–0.96). However, the occurrence of mild PEP was significantly reduced only in the subgroup receiving 20 mg nafamostat (OR, 0.49, 95% CI: 0.31–0.77). Overall, nafamostat therapy reduced moderate PEP in high‐risk patients (OR: 0.18, 95% CI: 0.0.4–0.84) and mild PEP in low‐risk patients (OR: 0.32, 95% CI: 0.17–0.61). Nafamostat is an effective therapy in the prevention of mild post‐ERCP pancreatitis. Further research is required to determine the cost‐effectiveness of this therapy.

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Is High-Dose Nafamostat Mesilate Effective for the Prevention of Post-ERCP Pancreatitis, Especially in High-Risk Patients?

Abstract: Nafamostat mesilate prophylaxis (20 or 50 mg) is effective in preventing post-ERCP pancreatitis. However, the preventive effect of high-dose nafamostat mesilate (50 mg) is not significant in high-risk patients.

Cited by 51 publications

References 28 publications

Systematic review with network meta‐analysis: pharmacological prophylaxis against post‐ERCP pancreatitis

Systematic review with network meta‐analysis: pharmacological prophylaxis against post‐ERCP pancreatitis

Postendoscopic retrograde cholangiopancreatography pancreatitis

Nafamostat Reduces the Incidence of post‐ERCP Pancreatitis: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

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