Am J Gastroenterol. 2023 Sep 21. doi: 10.14309/ajg.0000000000002499. Online ahead of print.
ABSTRACT
BACKGROUND: Successful biliary drainage and antibiotics are the mainstays of therapy in management of patients with acute cholangitis. However, the duration of antibiotic therapy after successful biliary drainage has not been prospectively evaluated. We conducted a single centre, randomized, non-inferiority trial to compare short and conventional duration of antibiotic therapy in patients with moderate or severe cholangitis.
METHODS: Consecutive patients were screened for the inclusion criteria and randomized into either conventional duration(CD group; 8 days) or short duration (SD group; 4 days) of antibiotic therapy. Primary outcome was clinical cure (absence of recurrence of cholangitis at day 30 and >50% reduction of bilirubin at day 15). Secondary outcomes were total days of antibiotic therapy and hospitalization within 30 days, antibiotic related adverse events and all-cause mortality at day 30.
RESULTS: The study included 120 patients(mean age was 55.85±13.52 years and 50% were males). Of them, 51.7% patients had malignant aetiology and 76.7% patients had moderate cholangitis. Clinical cure was seen in 79.66% (95%CI, 67.58%- 88.12%) patients in CD group and 77.97% (95%CI, 65.74%-86.78%) patients in SD group (p=0.822). On multivariate analysis, malignant aetiology and hypotension at presentation were associated with lower clinical cure. Total duration of antibiotics required post intervention was lower in SD group (8.58±1.92 and 4.75±2.32 days; p<0.001). Duration of hospitalization and mortality were similar in both the groups.
CONCLUSIONS: Short duration of antibiotics is non-inferior to conventional duration in patients with moderate to severe cholangitis in terms of clinical cure, recurrence of cholangitis and overall mortality.
PMID:37732816 | DOI:10.14309/ajg.0000000000002499