Nafamostat Mesylate is Not Effective in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Matsumoto, Takaaki; Okuwaki, Kosuke; Inoue, Hiroshi; Kida, Mitsuhiro; Iwai, Tomohisa; Yamauchi, Hiroshi; Kaneko, Toru; Hasegawa, Rikiya; Masutani, Hironori; Tadehara, Masayoshi; Adachi, Kai; Watanabe, Masafumi; Kurosu, Takahiro; Tamaki, Akihiro; Kikuchi, Hidehiko; Ohno, Takashi; Koizumi, Wasaburo

doi:10.1007/s10620-020-06782-6

Cited by 9 publications

(19 citation statements)

References 27 publications

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“…Then, after perusing the title and abstract, 281 irrelevant records were excluded, the remaining 44 records were searched, and we read the full text, 36 were excluded because they were retrospective studies, duplicate publications, review or meta-analyses, lack of clinical data and lack of placebo or blank control group. Finally, 8 studies, [23][24][25][26]30,[36][37][38] including 1 abstract, [37] met the inclusion criteria, and 3210 patients were ultimately selected to complete this systematic review and meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

“…[37] The assessments of research quality according to the modified Jadad scale and the Cochrane Collaboration tool are presented in Table 2 and Figure 2 and Supplementary Figure S1, http:// links.lww.com/MD/K352. On the basis of the modified Jadad scale, the scores of the included trials ranged from 3 to 6, 7 [23][24][25][26]30,36,38] trials enrolled in our meta-analysis are of high quality, and the quality of the one remaining study [37] is low.…”

Section: Risk Of Bias In Studiesmentioning

confidence: 99%

“…The incidence of PEP is the main outcome in our study, which was reported by all trials. In 7 high-quality studies, [23][24][25][26]30,36,38] PEP was defined in accordance with Cotton et al 's standard criterion. [39] Serum amylase level increases by 3 folds or more within 24 hours after ERCP procedure, accompanying canonical bellyache and other severe symptoms requiring hospital admission or prolonged hospitalization, which is considered PEP.…”

Section: Primary Outcomementioning

confidence: 99%

“…3, Table 3). Sensitivity analysis (Supplementary Figure S3, http://links.lww.com/MD/K354) shows that excluding the articles from Matsumoto et al, [30] the study risk ratio varies most obviously, from 0.50 (95% CI: 0.38-0.66) to 0.44 (95% CI: 0.32-0.60), but still cannot change the results, indicating the result of our meta-analysis is robust.…”

Section: Primary Outcomementioning

confidence: 99%

“…Nafamostat doses. Among all included studies, 5 studies [24][25][26]30,38] reported the data of PEP occurrence in patients that applied nafamostat in a dosage of 20 mg or a placebo, and 4 trials [23,25,36,37] presented the data of PEP occurrence in patients who accepted nafamostat in a dosage of 50 mg or a placebo. The heterogeneity test showed no substantial heterogeneity between the trials (I 2 = 0%, P = .49) (Fig.…”

Section: Subgroup Analysismentioning

confidence: 99%

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Nafamostat mesilate for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis based on prospective, randomized, and controlled trials

Xie,

Cheng,

Deng

et al. 2023

Medicine

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Objectives: To evaluate the efficacy of nafamostat mesilate in the prevention of post–endoscopic retrograde cholangiopancreatography pancreatitis (PEP) by conduct a systematic review and meta-analysis. Method: We retrieved for all randomized controlled trials (RCTs) about compare nafamostat mesilate with placebo in preventing PEP published before August 23, 2022, in 5 major electronic databases. The primary outcome was PEP rate, and the secondary outcome was post-ERCP hyperamylasemia (PEHA) rate. Subgroup analyses were performed to reveal the factors that may affect the preventive effect of nafamostat. Assessment of the quality of evidence was conducted based on Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. Results: According to the search strategy and criteria of inclusion and exclusion, 8 articles with a number of 3210 patients were included. The PEP incidence of the nafamostat group was inferior compared with the placebo group (4.6% vs 8.5%, RR = 0.50, 95% CI: 0.38–0.66). Subgroup analyses revealed that nafamostat had a preventive effect on patients with different risk stratification (High-risk: RR = 0.61, 95% CI: 0.43–0.86, Low-risk: RR = 0.28; 95% CI: 0.17–0.47). Different doses (20 mg: RR = 0.50, 95% CI: 0.36–0.69, 50 mg: RR = 0.45, 95% CI: 0.27–0.74) and duration (<12 hour: RR = 0.55, 95% CI: 0.37–0.81, ≥12 h: RR = 0.44, 95% CI: 0.29–0.66) of administration of nafamostat are adequate for the prevention of PEP, but postoperative administration may not help (preoperative: RR = 0.52, 95% CI: 0.39–0.69, postoperative: RR = 0.54, 95% CI: 0.23–1.23). Nafamostat may not efficacious in preventing severe PEP (Mild: RR = 0.49, 95% CI, 0.35–0.68, Moderate: RR = 0.47, 95% CI: 0.25–0.86, Severe: RR = 0.91, 95% CI, 0.25–3.29) or in low-quality studies (Low-quality: RR = 0.69, 95% CI: 0.13–3.60, High-quality: RR = 0.49, 95% CI: 0.37–0.65). Conclusion: Preoperative use of nafamostat can effectively prevent PEP in patients with various risk stratification. Nafamostat can prevent mild and moderate PEP, but may not prevent severe PEP and PEHA. There should be more high-quality RCTs in future to strengthen the evidence of nafamostat in preventing PEP.

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Section: Resultsmentioning

confidence: 99%

Section: Risk Of Bias In Studiesmentioning

confidence: 99%

Section: Primary Outcomementioning

confidence: 99%

Section: Primary Outcomementioning

confidence: 99%

Section: Subgroup Analysismentioning

confidence: 99%

See 3 more Smart Citations

Nafamostat mesilate for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis based on prospective, randomized, and controlled trials

Xie,

Cheng,

Deng

et al. 2023

Medicine

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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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Post-ERCP Pancreatitis — What Is the Best Approach for Prevention?

Jonason

Bilal²,

Trikudanathan

2022

Curr Treat Options Gastro

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Nafamostat Mesylate is Not Effective in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Cited by 9 publications

References 27 publications

Nafamostat mesilate for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis based on prospective, randomized, and controlled trials

Nafamostat mesilate for prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: A systematic review and meta-analysis based on prospective, randomized, and controlled trials

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

Post-ERCP Pancreatitis — What Is the Best Approach for Prevention?

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