Periprocedural Fluid Type and Volume Reduce the Risk of Post-ERCP Pancreatitis in High-Risk Patients: A Secondary Analysis of a Randomized Controlled Trial: 2017 ACG Governors Award for Excellence in Clinical Research

Abstract

Introduction: Aggressive hydration with lactated Ringer's was recently shown to be efficacious in reducing the incidence of post-ERCP pancreatitis (PEP) in a randomized controlled trial (RCT) of average risk patients undergoing ERCP. The impact of fluid on the incidence of PEP has not been evaluated in high risk patients. Methods: We conducted a secondary analysis of the effect of volume and type of intravenous fluid administered on the incidence of PEP in high risk patients who underwent ERCP as a part of a double blinded RCT comparing the efficacy of rectal indomethacin versus a combination of papillary spray of epinephrine and rectal indomethacin for the prevention of PEP. High risk patients were defined on the basis of prospectively validated patient and procedure-related risk factors. Patients who underwent planned therapeutic pancreatic stenting and those with suspected sphincter of Oddi dysfunction (SOD) type 3 were excluded from the study. PEP was defined as per the consensus criteria. The volume and type of fluid(s) infused during and after ERCP (periprocedural) were evaluated for their impact on the incidence of PEP using univariable logistic regression analysis. Results: A total 959 patients (mean age of 52.33±14.96 years; 551 (57.4%) females) were randomized during the trial, of whom 476 (49.6%) received periprocedural fluids (mean fluid administered 1245±629mL). The incidence of PEP was reduced in patients who received periprocedural fluid vs those who did not receive periprocedural fluid (5.2% vs 8.0%, P=0.079; OR, 0.65; 95% CI 0.38-1.09). Patients who developed PEP received a lower mean volume of fluid compared to those who did not develop PEP (752±783mL vs. 1012±725mL, P=0.036). There were 174 patients (37%) who received lactated Ringer's (LR). Patients who developed PEP received a lower mean volume of LR compared to those who did not develop PEP (329±356 vs. 570±559mL, P=0.006). The use of LR was associated with a lower risk of PEP compared to those who received all other types of fluid (5.8% vs 9.8%, P=0.047; OR, 0.56; 95% CI 0.31-0.99, P=0.047). Conclusion: Higher mean volume of periprocedural fluids and use of lactated Ringer's solution further reduces the incidence of post-ERCP pancreatitis beyond rectal indomethacin based on this subgroup analysis of a pharmacological prophylaxis PEP trial conducted in high risk patients.Table: No Caption available.