Aims
The overall documented PEP rate is 3.5% to 9.7%, while the rate of high-risk patients is 14.7%. The guidelines recommend a minimum standard of <10% of PEP, with a target of 5.1%.
There are well-recognized risk factors, including suspected SOD, previous pancreatitis, previous PEP, female sex, difficult cannulation, pancreatic guidewire passages >1 and pancreatic injection. There are likely risk factors as younger age, nondilated extrahepatic bile duct, normal serum bilirubin, end-stage renal disease, biliary balloon sphincter dilation, failure to clear bile duct stones.
ESGE suggests that patients should be considered to be at high risk for PEP when at least one definite or two likely patient-related or procedure-related risk factors are present.
ESGE recommends PEP prophylaxis using rectal administration of 100mg of diclofenac or indomethacin immediately before ERCP in all patients in whom a contraindication does not exist. Current ESGE and ASGE do not recommend routine combination prophylaxis in all patients. Current studies demonstrated potential benefits in combining rectal NSAIDs with other strategies.
Methods
Objective: There are studies that compares aggressive hydration with Ringer lactate versus moderate hydration with saline solution during and after procedures. We describe the first results of a combination of a conservative hydration regimen with Hartmann´s solution and NSAIDs, since we already using indomethacin. Among patients with high risk for PEP, compare indomethacin with moderate IV hydration versus indomethacin with modified aggressive IV hydration.
Material and methods: Prospective study, including adult patients >18yo, with high risk of post-ERCP pancreatitis, from 2022 to 2024 at Hospital General de Tláhuac, a 2nd level hospital in México City.
The patients were randomly assigned to a combination of rectal indomethacin combined with a modified aggressive hydration (maximum 1.5ml/kg/hr during procedure, 20mg/kg bolus of Hartmann solution at the end of procedure, followed by 3ml/kg/hr for 8 hours) or indomethacin combined with moderate hydration (maximum 1.5ml/kg/hr during and after the procedure for 8 hours).
Inclusion criteria: Adult patients >18yo with at least one definite or two likely patient-related or procedure-related risk factors are present before undergoing to ERCP, with a documented indication. Patients with additional pancreatic stent were excluded.
Descriptive analysis with measures of central tendency for quantitative variables and frequency distribution for qualitative variables.
Results
Between January 2021 and December 2024, 71 patients met the criteria for high-risk patients to develop PEP, with a total of 87 procedures. There was a total of 37 patients in the group of indomethacin with modified moderate hydration and 50 patients in the modified aggressive hydration group.
A total of 11 (12.7%) patients developed PEP, consistent with literature of 14.7% high-risk PEP patients. It is worth mentioning that if we break down the rate by year, the percentage of PEP fell to 5.7% during 2024, possibly due to the learning curve of the newly graduated endoscopist. Among high-risk patients receiving rectal indomethacin, the incidence of post-ERCP pancreatitis was 13.5% (5/37) in the indomethacin with modified moderate hydration group and 12.0% (6/50) in the indomethacin plus modified aggressive hydration regimen group. There was no statistically significant difference between groups (RR 1.13, 95% CI 0.37–3.41; OR 1.15, 95% CI 0.32–4.09; Fisher’s exact test p = 1.00).
Conclusions
At least in these early results, the modified hydration regimen shows that it is not inferior than the established one. There was no significant difference in the incidence of post-ERCP pancreatitis between both groups