Abstract
Introduction: In liver transplant centers, ERCP is a necessary tool in managing post-transplant complications such as strictures and biliary leaks. Post-ERCP pancreatitis (PEP) can be a devastating adverse event in this fragile patient population. Animal models have demonstrated a protective effect of tacrolimus on acute pancreatic inflammation with a reduction in histologic inflammation, amylase, and IL-6 levels. Data on human subjects is yet to be published. OBJECTIVE: Assess the clinical efficacy of tacrolimus therapy in reducing PEP. Methods: We performed a retrospective query of the University of Cincinnati Medical Center endoscopy and surgical databases to identify patients with a native papilla who underwent biliary ERCP. These patients were divided into two groups based on tacrolimus use at the time of the procedure, the tacrolimus and control arms. Patients who underwent pancreatic cannulation only were excluded. The primary outcome was the rate of post-ERCP pancreatitis. Stats (SPSSv22): Proportions compared by chi-square and Fisher's exact test. Results: From 1/2013 to 08/2017, 98 liver transplant patients with a native papilla and treated with tacrolimus underwent biliary ERCP (56% M, median age 57). During the same time period, we randomly identified 171 patients for the control arm who underwent ERCP, 157of which were included for study (50% M, median age 60). Of these control subjects, 14 were excluded due to pancreatic cannulation only. Biliary ES occurred in 60/98 (61%) versus 109/157 (69%) in the study and control arms, respectively (p= 0.164). Biliary stents were placed in 77/98 (79%) patients who received tacrolimus and in 74/157 (47%) of control patients (p Conclusion: Contrary to data published in animal models, concurrent therapy with tacrolimus at the time of biliary ERCP was not effective in reducing the incidence of post-ERCP pancreatitis in our study. Further prospective randomized trials are needed to assess the efficacy of tacrolimus as monotherapy or as an adjunct to indomethacin for the reduction post-ERCP pancreatitis.