Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial.

BACKGROUND AND STUDY AIMS: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP. PATIENTS AND METHODS: This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine. RESULTS: Of the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009). CONCLUSION: Spraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP. TRIAL REGISTRATION NUMBER: This study was registered with ClinicalTrials.gov (NCT02959112).

The impact of different infectious complications on mortality of hospitalized patients with liver cirrhosis.

INTRODUCTION AND OBJECTIVES: Bacterial infections are common complications in patients with cirrhosis and are associated with poor prognosis. There are no studies that analyze the impact of different infectious complications in the mortality of these patients, so we aimed to perform this evaluation. MATERIALS AND METHODS: We performed a case-control study in adult patients with cirrhosis with a follow-up period of one year. We recorded demographic data, prognostic scales, infectious complications and mortality at 30, 90 and 365 days. For the survival analysis, Kaplan-Meyer survival curve was performed and hazard ratios were calculated with 95% confidence intervals by Cox-regression in univariate and multivariate models. For the comparison between groups the Chi squared test, Fisher's exact test and Mann-Whitney U test were performed. RESULTS: We included 500 patients. Median age was 58 years, predominant sex was woman (52%) and the most common infections were urinary tract infections (35%), pneumonia (28.2%) and spontaneous bacterial peritonitis (SBP) (18%). From the patients, 40.4% were CTP score C and median MELD score was 15. In the univariate analysis, infections in general, SBP, pneumonia and central nervous system (CNS) infections had an increased mortality at the three follow up periods, however in the multivariate analysis with the prognostic scales, only pneumonia (HR 2.03, CI 95%[1.06-3.86]) and CNS infections (HR 4.84, CI 95%[1.38-16.93]) remained with increased mortality. CONCLUSIONS: Some infectious complications, as pneumonia and CNS infections, increase mortality in hospitalized patients with cirrhosis, regardless of the severity of liver disease.