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- Title
Nafamostat Mesylate is Not Effective in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.
- Authors
Matsumoto, Takaaki; Okuwaki, Kosuke; Imaizumi, 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
- 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.
- Subjects
ENDOSCOPIC retrograde cholangiopancreatography; PANCREATITIS; RANDOMIZED controlled trials; PROTEASE inhibitors; INJECTIONS
- Publication
Digestive Diseases & Sciences, 2021, Vol 66, Issue 12, p4475
- ISSN
0163-2116
- Publication type
Article
- DOI
10.1007/s10620-020-06782-6