The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019).

BACKGROUND: Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment. METHODS/DESIGN: These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm. DISCUSSION: The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course. TRIAL REGISTRATION: NTR2883 ; ISRCTN56523019.

Antimicrobial therapy of 3 days or less is sufficient after successful ERCP for acute cholangitis.

BACKGROUND: Recommendations for the duration of antimicrobial therapy in cholangitis after successful endoscopic biliary drainage vary. The aim of this study was to compare the occurrence of local infectious complications in patients with acute cholangitis treated with antibiotics for 3 days or less compared with 4 days or more. METHODS: We performed a retrospective multicentre study in seven hospitals in the Netherlands. Patients who received a successful biliary drainage by endoscopic retrograde cholangio-pancreatography because of cholangitis due to common bile duct stones between 2012 and 2017 were included. The primary outcome was the occurrence of a local infectious complication within 3 months of endoscopic retrograde cholangio-pancreatography. Secondary outcomes included Clostridioides difficile infection, total length of hospital stay and all-cause mortality. RESULTS: A total of 426 patients with cholangitis were identified and 296 patients met all inclusion criteria. Therapy duration was ≤3 days in 137 patients (46.3%). During follow-up, 41 patients (13.9%) developed a local infectious complication. Occurrence of infectious complications did not differ between the two groups (p = 0.32). No patient developed Clostridioides difficile infection. Median hospital stay was 6 days (interquartile range 4-8 days) in the short antibiotic group compared with 7 days (interquartile range 5-9 days) in the long group (p = 0.03). Four (1.4%) patients died during follow-up, all were treated for ≥4 days (p = 0.13). CONCLUSIONS: Antimicrobial therapy of 3 days or less seems to be sufficient after successful biliary drainage in patients with acute cholangitis. Randomized trials should confirm our findings.