Nafamostat Mesylate is Not Effective in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.
Dig Dis Sci
; 66(12): 4475-4484, 2021 12.
Article
em En
| MEDLINE
| ID: mdl-33495919
ABSTRACT
BACKGROUND:
Endoscopic retrograde cholangiopancreatography (ERCP) is associated with complications such as post-ERCP pancreatitis (PEP). Protease inhibitors, including nafamostat mesylate (NM), have been evaluated for prophylaxis against PEP.AIM:
We describe the first multicenter randomized controlled trial assessing the prophylactic efficacy of NM against PEP.METHODS:
In this multicenter prospective study, we aimed to enroll 800 patients aged ≥ 20 years with a planned ERCP between December 2012 and March 2019. The primary outcome was the incidence and severity of PEP in patients who did not receive NM (non-NM) versus those who did (NM; 20 mg). Secondary outcomes included the incidence of PEP by NM initiation (pre- and post-ERCP), risk factors for PEP, and NM-related adverse events.RESULTS:
Only 441 of the planned 800 patients were enrolled (non-NM n = 149; NM n = 292 [pre-ERCP NM n = 144; post-ERCP NM n = 148]). Patient characteristics were balanced at baseline with no significant differences between groups. PEP occurred in 40/441 (9%) patients (non-NM n = 15 [10%]; NM n = 25 [9%]), including 17 (12%) and eight (8%) in the pre-ERCP and post-ERCP NM groups, respectively. In the NM group, the incidence of PEP was lower in the low-risk group than in the high-risk group. Pancreatic injection and double-guidewire technique were independent risk factors for PEP. NM-related adverse events of hyperkalemia occurred in two (0.7%) patients.CONCLUSIONS:
We found no evidence for the prophylactic effect of NM against PEP, regardless of the timing of administration; however, further studies are needed.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Pancreatite
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Benzamidinas
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Inibidores da Tripsina
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Colangiopancreatografia Retrógrada Endoscópica
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Guanidinas
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article