Purpose: The Tokyo guidelines were proposed in 2007 to define uniform, evidence-based criteria for the diagnosis, severity assessment, and treatment of acute cholangitis (AC). Its utility for the diagnosis and management of AC secondary to malignant obstruction has not been validated. Our aims include assessment of the diagnostic accuracy, rate of adherence to treatment strategy, and impact of the Tokyo guidelines on clinical outcomes in patients with benign and malignant obstruction. Methods: We retrospectively reviewed all patients who underwent endoscopic biliary drainage for AC at a Chinese national referral center from 2001 to 2009. We included patients who fulfilled the following clinical, endoscopic, and laboratory parameters: detection of purulent bile or pus during endoscopic biliary drainage, presence of fever or chills, leukocytosis or elevated C-reactive protein in the setting of cholangitis. Descriptive statistics and univariate analyses were conducted to compare clinical parameters and outcomes of patients with benign and malignant obstruction in relation to the Tokyo guidelines. Results: There were 120 patients of which 82 (68.3%) had benign disease and 38 (31.6%) with malignant obstruction. The demographic characteristics include: mean age 66 ± 15 y.o., 85 (69.1%) males. Charcot's triad was present in only 61 (50.8%) patients as compared to 104 (86.7%) patients who fulfilled the Tokyo diagnostic criteria for definitive AC (p<0.0001). The diagnostic accuracy of the Tokyo guidelines were 82.9% and 94.7% for benign and malignant obstruction, respectively (p=0.05). There were 58 (70.7%) patients with benign obstruction who underwent endoscopic drainage compared to 15 (39.5%) patients with malignant obstructive etiology treated consistently with the Tokyo guidelines (p=0.001). The difference in adherence was predominately observed in patients with AC of moderate severity. In comparing patients who received treatment consistent with or independent from the Tokyo guidelines, we found no significant difference in their clinical outcomes in terms of: length of hospital stay, incidence of repeated endoscopic treatment, success rate of endoscopic drainage, incidence of complications, and early death within 30 days of admission; regardless of benign or malignant obstructive etiology. Conclusion: The Tokyo guidelines can be a reliable tool for the diagnosis of AC for both benign and malignant obstruction. It is superior over the clinical criteria of Charcot's triad. Patients with benign obstruction are more likely to receive endoscopic biliary drainage consistent with the Tokyo guidelines. However, there was no effect on the clinical outcomes in adherence with the Tokyo guidelines for the management of AC.
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