Early Management of Severe Biliary Infection in the Era of the Tokyo Guidelines.

Sepsis of biliary origin is increasing worldwide and has become one of the leading causes of emergency department admissions. The presence of multi-resistant bacteria (MRB) is increasing, and mortality rates may reach 20%. This review focuses on the changes induced by the Tokyo guidelines and new concepts related to the early treatment of severe biliary disease. If cholecystitis or cholangitis is suspected, ultrasound is the imaging test of choice. Appropriate empirical antibiotic treatment should be initiated promptly, and selection should be performed while bearing in mind the severity and risk factors for MRB. In acute cholecystitis, laparoscopic cholecystectomy is the main therapeutic intervention. In patients not suitable for surgery, percutaneous cholecystostomy is a valid alternative for controlling the infection. Treatment of severe acute cholangitis is based on endoscopic or transhepatic bile duct drainage and antibiotic therapy. Endoscopic ultrasound and other new endoscopic techniques have been added to the arsenal as novel alternatives in high-risk patients. However, biliary infections remain serious conditions that can lead to sepsis and death. The introduction of internationally accepted guidelines, based on clinical presentation, laboratory tests, and imaging, provides a framework for their rapid diagnosis and treatment. Prompt assessment of patient severity, timely initiation of antimicrobials, and early control of the source of infection are essential to reduce morbidity and mortality rates.

Predicting early biliary infection after stenting of malignant biliary obstruction: model development and internal validation.

PURPOSE: To analyze the risk factors and develop a clinical prediction model for early biliary infection (EBI) after percutaneous transhepatic biliary stenting (PTBS) in patients with malignant biliary obstruction (MBO). METHODS: The clinical data of 236 patients with MBO treated with PTBS from June 2012 to June 2021 were retrospectively analyzed. Independent risk factors were analyzed by univariate and multivariate logistic regression, and a nomogram model was constructed based on the results. Discrimination, calibration, and clinical usefulness of this model were further assessed. RESULTS: The technical success rate of PTBS was 100%, and EBI after PTBS was 20.3%. Multivariate logistic regression analysis showed that hilar MBO (P = 0.020), diabetes (P = 0.001), previous surgical or endoscopic intervention (P = 0.007), procedure time > 60 min (P = 0.007), and intraprocedural biliary hemorrhage (P = 0.003) were independent risk factors for EBI after PTBS. A nomogram model was developed to predict the probability of EBI. ROC curves showed good discrimination of the model (area under curve = 0.831). The calibration plot indicated that the predicted probability of EBI by this model was in good agreement with the actual probability of EBI. The DCA curves showed that the net benefit of nomogram-assisted decisions was higher than or equal to the net benefit of treatment for all or none at a wide threshold probability (0-0.8). CONCLUSION: The nomogram model based on the above independent risk factors can predict the probability of EBI and model-assisted treatment decisions contribute to improved clinical outcome. Therefore, MBO patients with probability of EBI > 0.20 based on the model should be recommended for perioperative broad-spectrum antibiotics and close monitoring.

Sarcopenia increases the risk of early biliary infection after percutaneous transhepatic biliary stent placement.

Purpose: To assess the association between sarcopenia and the risk of early biliary infection (EBI) after percutaneous transhepatic biliary stent (PTBS) placement in patients with inoperable biliary tract cancer (BTC). Patients and methods: In this single center, retrospective observational study, patients diagnosed with inoperable BTC undergoing PTBS placement between January 2013 and July 2021 were enrolled. Preoperative sarcopenia was defined based on skeletal muscle mass measured by computed tomography images on the level of third lumbar vertebra within one month before PTBS placement. Patients were divided into two groups in accordance with the status of sarcopenia. Univariate and further multivariate logistic analyses were performed to determine predictors for EBI. Stratified and interactive analyses were conducted to investigate the stability of results. Further receiver operating characteristic curve was performed to determine the predictive value of sarcopenia on EBI after PTBS placement. Results: Totally, 134 patients were included in this retrospective study, with 45 (33.6%) patients characterized as sarcopenia. The incidence rate of EBI was 26.9% (36/134). Multivariate analyses demonstrated that sarcopenia [Odds ratio (OR), 2.75; 95%CI: 1.11-6.77; P=0.028], obstruction length (OR, 1.04; 95%CI: 1.00-1.08; P=0.030) and diabetes (OR, 2.46; 95%CI: 1.01-5.96; P=0.047) were significant predictors of EBI. There were no significant interactions in different subgroups (P for interaction > 0.05). Moreover, the areas under the curves (AUC) revealed that the combined index containing sarcopenia, obstruction length, and diabetes showed the better predictive value (AUC= 0.723) than either one alone. Conclusion: Sarcopenia increased the risk of EBI in patients with inoperable BTC after PTBS placement. Preoperative assessment of sarcopenia may aid in risk stratification. Patients with sarcopenia should be given intensive monitoring.

Biliary-Caval Fistula following Y90 Radioembolization.

The safety of radioembolization with yttrium-90 ( 90 Y) is well documented and major complications are rare. Previous studies have demonstrated that biliary complications following 90 Y, including bile duct injury and hepatic abscess formation, occur at an increased rate in patients who have had prior biliary surgery and interventions. This article reviews a case of a patient who developed recurrent cholangitis and sepsis as well as a biliary-caval fistula following radioembolization. Additionally, we review current data regarding biliary complications following radioembolization in patients with prior biliary intervention.

Comparative analysis of bile culture and blood culture in patients with malignant biliary obstruction complicated with biliary infection.

OBJECTIVE: This study is aimed to provide a clinical basis for the identification and treatment of patients with malignant biliary obstruction (MBO) complicated with biliary infection by comparing pathogenic bacteria detected in bile and blood cultures from these patients. MATERIALS AND METHODS: A total of 380 patients with MBO who received percutaneous transhepatic cholangic drainage from January 2004 to January 2019 were included in the study. A total of 90 patients were diagnosed with having MBO complicated with biliary infection, and bile and blood culture were simultaneously performed on these patients. The patients included 58 men and 32 women, ranging in age from 33 to 86 years old, with a mean age of 60.69 years. RESULTS: The detection rate using bile bacterial culture in patients with MBO complicated with biliary infection was significantly higher than that using blood culture, and there were significant differences in the two kinds of bacterial culture found positive bile and blood cultures from the same patients. Gram-positive cocci were dominant in the bile cultures and Gram-negative bacilli were dominant in the blood cultures. Therefore, it is necessary to conduct simultaneous bile bacterial culture and blood culture for patients with MBO complicated with biliary infection, especially those with severe or critical diseases. CONCLUSIONS: It is vital to enable simultaneous bile bacterial culture and blood culture in patients with MBO complicated with biliary infection. Existing guidelines for the diagnosis and treatment of benign biliary infection are not applicable to patients with MBO complicated with biliary infection.

Acute Cholangitis: Causes, Diagnosis, and Management.

Acute cholangitis, also referred to as ascending cholangitis, is an infection of the biliary tree characterized by fever, jaundice, and abdominal pain, which in most cases is the consequence of biliary obstruction. Diagnosis is commonly made by the presence of clinical features, laboratory tests, and imaging studies. The treatment modalities include administration of intravenous fluids, antimicrobial therapy, and prompt drainage of the bile duct. Early diagnosis and treatment of acute cholangitis are crucial to prevent unwanted clinical outcome of the disease. This article provides an update on early diagnosis and management of acute cholangitis.

Differences in Bile Microbiology and Antibiotic Resistances between Liver Transplant Recipients and Non-Transplant Patients.

Background: Treatment of biliary infection in liver transplant (LT) recipients is a challenge, especially because of ineffectiveness of the antibiotic agents otherwise recommended for non-transplant populations. We aimed to understand the factors underlying the choice of antibiotic therapy. Patients and Methods: A total of 373 bile cultures from LT recipients with biliary complications (n = 127; LT group) and from a non-transplant population that underwent cholecystectomy for acute cholecystitis (n = 246; non-transplant group) between January 2009 and December 2018, were investigated. Results: Polymicrobial cultures (13.4% vs. 1.6%; p < 0.001), Enterococcus faecium (26.0% vs. 8.5%; p < 0.001), and Pseudomonas (13.4% vs. 4.1%; p = 0.001) in the LT group, and non-faecium enterococci (3.9% vs. 18.3%; p < 0.001) and Enterobacteriales (40.2% vs. 54.9%; p = 0.007), especially Escherichia (11.0% vs. 29.7%; p < 0.001), in the non-transplant group, showed higher abundance. Most of the antibiotic agents recommended as initial antibiotic therapy for the non-transplant population as per previous guidelines were not effective in LT recipients. The incidences of Enterococcus faecium (14.9% vs. 32.5%; p = 0.029) in the LT recipients with model for end-stage liver disease (MELD) score >12 and non-faecium enterococci (8.5% vs. 1.3%; p = 0.042) in those with MELD score ≤12 were higher than those in the other group. The incidence of Enterobacteriales increased over time after LT (p = 0.048) and was similar to that in the non-transplant group after one year of LT. Bile micro-organisms in LT recipients, resistant to most antibiotic agents, especially soon after LT changed over time and became similar to those in the non-transplant group after one year of LT. Conclusions: Antibiotic therapy for biliary infection in LT recipients should be different from that in non-transplant populations, considering clinical factors such as the time interval after LT and MELD score.

Clinical characteristics and outcomes of Staphylococcus aureus bacteremia from a biliary source.

Staphylococcus aureus is a virulent gram-positive organism, which rarely involves the biliary tract. This study aimed to analyze the clinical characteristics and outcomes of S. aureus bacteremia (SAB) originating from the biliary tract by comparing them with those of catheter-related SAB and biliary Klebsiella pneumoniae bacteremia. A matched case-control study within a prospective observational cohort of patients with SAB was conducted. Biliary SAB was defined as the isolation of S. aureus from blood cultures with symptoms and signs of biliary infection. Biliary SAB patients were matched (1:3) with the control groups: patients with catheter-related SAB and biliary Klebsiella pneumoniae bacteremia. Out of 1818 patients with SAB enrolled in the cohort, 42 (2%) had biliary SAB. Majority of these patients had solid tumors involving the pancreaticobiliary tract or liver, biliary drainage stent, and/or recent broad-spectrum antibiotic exposure. Patients with biliary SAB were more likely to have community-onset SAB, solid tumors, and lower APACHE II score than those with catheter-related SAB. They were less likely to have community-acquired infection and solid tumors and more likely to have lower Charlson comorbidity index and higher APACHE II score as compared with biliary K. pneumoniae bacteremia. The 12-week mortality in the biliary SAB group was higher than those in other control groups (60% vs. 20% and 14%). After adjusting for confounding factors, biliary SAB was independently associated with higher mortality. Biliary SAB is relatively rare. When it is clinically suspected, early aggressive treatment should be considered due to high mortality.

Diagnosis and treatment strategies for acute biliary infection during the epidemic period of COVID-19 / 解放军医学杂志

Acute biliary infection is one of the common causes of acute abdomen, easily causes severe infection and even death. The reasonable treatment of the acute phase is very important. The sudden outbreak of corona virus disease (COVID-19) has posed severe challenges to the country's economic and social life, and has also led to an extreme shortage of medical resources. The diagnosis and treatment of acute biliary infections disease also face challenges. In order to control the epidemic of infectious diseases, we write this article from the perspective of prevention and controlling of COVID-19, referring to the Tokyo Guidelines 2018 to express our views on the diagnosis and treatment strategies for acute biliary infection, hoping to do our best to prevent and control the epidemic of COVID-19.

Cholangitis: Causes, Diagnosis, and Management.

Acute cholangitis remains a potentially lethal disease if not appropriately diagnosed in a timely fashion. Modern diagnostic and therapeutic modalities have greatly decreased mortality from acute cholangitis. This article aims to provide an up-to-date synopsis of empirically tested diagnostic criteria as well as an overview of the expanding interventions available.

Multifactorial analysis of biliary infection after percutaneous transhepatic biliary drainage treatment of malignant biliary obstruction.

BACKGROUND: The symptoms of patients with malignant biliary obstruction (MBO) could be effectively alleviated with percutaneous transhepatic biliary drainage (PTBD). Postoperative infections were considered as challenging issues for clinicians. In this study, the risk factors of biliary infection in patients after PTBD were analyzed. METHODS: From July 2003 to September 2010, 694 patients with MBO received PTBD treatment. Bile specimens were also collected during PTBD. All relevant information and results were collected, including gender, age, obstruction time, types of primary tumor, sites of obstruction, drainage style, tumor stage, hemoglobin, phenotype of peripheral blood monocyte (Treg), total bilirubin, direct bilirubin, albumin, Child-Pugh score, and results of bile bacterial culture. RESULTS: For the 694 patients involved in this study, 485 were male and 209 were female, with a mean age of 62 years (ranged 38-78 years). For the bile culture, 57.1% patients (396/649) were negative and 42.9% patients showed positive (298/694), and then 342 strains of microorganism were identified. The risk factors of biliary system infection after PTBD included: age (χ2 = 4.621, P = 0.032), site of obstruction (χ2 = 17.450, P < 0.001), drainage style (χ2 = 14.452, P < 0.001), tumor stage (χ2 = 4.741, P = 0.029), hemoglobin (χ2 = 3.914, P = 0.048), Child-Pugh score (χ2 = 5.491, P = 0.019), phenotype of peripheral blood monocyte (Treg) (χ2 = 5.015, P = 0.025), and results of bile bacterial culture (χ2 = 65.381, P < 0.001). Multivariate analysis suggested that high-risk factors were drainage style, Child-Pugh score, and results of bile culture. CONCLUSIONS: The risk factors of biliary infection after PTBD included: age, site of obstruction, drainage style, tumor stage, hemoglobin, Child-Pugh score, phenotype of peripheral blood monocyte (Treg), and results of bile culture. It was further concluded that drainage style, Child-Pugh score, and results of bile culture were independent risk factors.

Acute cholangitis - an update.

Acute cholangitis is bacterial infection of the extra-hepatic biliary system. As it is caused by gallstones blocking the common bile duct in most of the cases, its prevalence is greater in ethnicities with high prevalence of gallstones. Biliary obstruction of any cause is the main predisposing factor. Diagnosis is established by the presence of clinical features, laboratory results and imaging studies. The treatment modalities include administration of intravenous fluid, antibiotics, and drainage of the bile duct. The outcome is good if the treatment is started early, otherwise it could be grave.

Cholelithiasis - always infected?

This study aims to present results regarding the presence and identification of bacterial strains found in bile and gallstones located in the gallbladder and bile ducts in patients operated on due to cholelithiasis. MATERIALS AND METHODS: Bacterial culture was evaluated in 92 patients. There were 54 women (59%) and 38 men (41%) who underwent surgery on account of cholelithiasis and /or gallstones in bile ducts between 2013 and 2014. Bile and gallstone samples were cultured intraoperatively for bacteria; bacterial strains were identified, and their sensitivity to antibiotics was determined. Molecular methods (NGS and Sanger method) were used to separate bacterial strains in one of the gallbladder stones and the results were compared with bacterial strains grown from the bile. RESULTS: Bile cultures were positive in 46 patients that is, 50% of the study group. The following bacteria strains were grown: Enterococcus spp. (44%), Escherichia coli (37%) and Klebsiella spp. (35%). Candidiasis accompanied by bacterial infection was detected in 7 patients (15%). Molecular testing of gallstones revealed DNA of Enterococcus spp., Escherichia spp., Streptococcus spp. and Clostridium spp. In the bile culture of the same patient Enterococcus spp. (avium and faecalis) was detected. Conclusion 1. More than one pathogen was grown on samples obtained from 31 patients (70%) with bile infection. 2. The most common pathogens include Enterococcus spp., Escherichia coli and Klebsiella spp. 3. Bacterial infections are often accompanied by a fungal infection (Candida albicans) 4. Bacterial strains grown from a gallstone sample partially corresponded with strains identified in the bile of the same patient.

Risk factors for ERCP-related complications:a review of 1 951 cases / 中华消化内镜杂志

Objective To investigate the risk factors for post-ERCP complications. Methods Data of the patients who underwent ERCP in the First Affiliated Hospital of Nanchang University from 1 January 2011 to 31 December 2013 were retrospectively analyzed. Post-ERCP complications were analyzed by univariate and multivariate analyses. Results A total of 277 patients out of 1 951 developed complications, 101(5.18%)pancreatitis, 54(2.77%)hyperamylasemia(not including pancreatitis), 134(6.87%) biliary infection,8(0.41%)hemorrhage,1(0.05%)obstruction and 1(0.05%)perforation.Multivariate analyses showed cholangiocarcinoma(P=0.002,OR=2.39, 95% CI:1.38-4.14), long operation time(>60 min)(P=0.020,OR=3.77,95%CI:1.23-11.53)and endoscopic sphincterotomy(EST)(P=0.008, OR=2.56,95% CI:1.28-5.14)and entrance of guidewire to pancreatic duct(P=0.012,OR=1.43, 95%CI:1.08-1.87)were independent risk factors for PEP. Cholangiocarcinoma(P<0.01, OR=2.93, 95%CI:1.88-4.56),multiple times of ERCP during the period of hospitalization(P<0.01, OR=2.53, 95%CI:1.63-3.93)were independent risk factors for post-cholangitis. However, EST(P=0.03, OR=0.65,95%CI:0.44-0.97)and antibiotics prophylaxis after ERCP(P=0.03, OR=0.64, 95% CI:0.39-0.95)were protective factors for post-cholangitis. ConclusionCholangiocarcinoma, endoscopic sphincterotomy, long operation time(> 60 min)and entrance of guidewire to pancreatic duct were independent risk factors for PEP. Cholangiocarcinoma and multiple ERCP during the period of hospitalization are independent risk factors for post-cholangitis.EST and antibiotics prophylaxis after ERCP might reduce the occurrence of cholangitis.

Validez diagnóstica de la endosonografía biliopancreática en el diagnóstico de colangitis aguda secundaria a obstrucción biliar / Diagnostic Validity of Biliopancreatic Endosonography in the Diagnosis of Acute Cholangitis Secondary to Biliary Obstruction

Resumen El diagnóstico de las colangiopatías obstructivas por endosonografía biliopancreática (EUS, por sus siglas en inglés) se ha estudiado en profundidad, y existe un extenso reconocimiento de su papel para el diagnóstico de coledocolitiasis, tumores de la encrucijada biliopancreática y síndromes de compresión extrínseca de la vía biliar. La colangitis, la complicación más frecuente de la obstrucción biliar y responsable de gran parte de su morbimortalidad, no se ha relacionado en forma suficiente con los hallazgos endosonográficos. Nuestro estudio buscó definir la validez diagnóstica de la endosonografía en los pacientes con colangitis aguda con el fin de limitar la morbimortalidad del retraso diagnóstico. Se realizó un estudio descriptivo, analizando las historias clínicas de pacientes sometidos a endosonografía biliopancreática, por ictericia obstructiva de cualquier etiología, y quienes posteriormente fueron llevados a colangiopancreatografía retrógrada endoscópica (CPRE) para manejo de obstrucción biliar. Comparamos los hallazgos endosonográficos compatibles con colangitis aguda (engrosamiento de la vía biliar de 1,5 mm o más, presencia de halo pericolangítico de al menos 1,5 cm de longitud y presencia de contenido de ecogenicidad mixta en el interior de la vía biliar) con el drenaje purulento durante la CPRE. Se encontró una alta frecuencia de estos hallazgos en los pacientes con colangitis, y el engrosamiento de las paredes de la vía biliar fue el más común, en el 92,6% de los casos, seguido por la presencia de halo pericolangítico en el 59,3% de los casos y contenido ductal en el 66,7% de los casos. Igualmente, se encontró asociación ascendente de las frecuencias con grado de severidad de la colangitis. Resulta recomendable realizar estudios con un mayor poder estadístico que permitan validar nuestros resultados para una futura inclusión de la EUS en el algoritmo diagnóstico de las guías de práctica clínica en colangitis aguda.

Abstract Diagnosis of obstructive cholangiopathy with biliopancreatic endosonography (BUS) has been extensively studied, and its role in the diagnosis of choledocholithiasis, biliopancreatic junction tumors and extrinsic biliary compression syndromes is widely recognized. Endosonographic diagnosis of cholangitis, a more frequent complication of biliary obstruction which is responsible for much of its morbidity and mortality, has not been sufficiently studied. Our study's objective is to define the diagnostic validity of endosonography for patients with acute cholangitis in order to limit morbidity and mortality due to diagnostic delay. This is a descriptive study that analyzes clinical histories of patients who underwent biliopancreatic endosonography because of obstructive jaundice of any etiology and who later underwent endoscopic retrograde cholangiopancreatography (ERCP) to manage biliary obstruction. We compared endosonographic findings compatible with acute cholangitis: thickening of the bile duct of 1.5 mm or more, periportal halo sign of at least 1.5 cm in length, mixed echogenicity of bile duct content, and purulent drainage during ERCP. Patients with cholangitis most frequently presented thickened gallbladders (92.6% of cases) periportal halo signs (59.3% of cases) and mixed echogenicity of bile duct content (66.7% of cases). We also found an ascending association of frequencies with the degree of severity of cholangitis. Studies with greater statistical power are needed for validation of our results and for future inclusion of EUS in the diagnostic algorithm for clinical practice guidelines in cases of acute cholangitis.

Intra-abdominal Infections: The Role of Anaerobes, Enterococci, Fungi, and Multidrug-Resistant Organisms.

BACKGROUND: Intra-abdominal infections (IAI) constitute a common reason for hospitalization. However, there is lack of standardization in empiric management of (1) anaerobes, (2) enterococci, (3) fungi, and (4) multidrug-resistant organisms (MDRO). The recommendation is to institute empiric coverage for some of these organisms in "high-risk community-acquired" or in "healthcare-associated" infections (HCAI), but exact definitions are not provided. METHODS: Epidemiological study of IAI was conducted at Assaf Harofeh Medical Center (May-November 2013). Logistic and Cox regressions were used to analyze predictors and outcomes of IAI, respectively. The performances of established HCAI definitions to predict MDRO-IAI upon admission were calculated by receiver operating characteristic (ROC) curve analyses. RESULTS: After reviewing 8219 discharge notes, 253 consecutive patients were enrolled (43 [17%] children). There were 116 patients with appendicitis, 93 biliary infections, and 17 with diverticulitis. Cultures were obtained from 88 patients (35%), and 44 of them (50%) yielded a microbiologically confirmed IAI: 9% fungal, 11% enterococcal, 25% anaerobic, and 34% MDRO. Eighty percent of MDRO-IAIs were present upon admission, but the area under the ROC curve of predicting MDRO-IAI upon admission by the commonly used HCAI definitions were low (0.73 and 0.69). Independent predictors for MDRO-IAI were advanced age and active malignancy. CONCLUSIONS: Multidrug-resistant organism-IAIs are common, and empiric broad-spectrum coverage is important among elderly patients with active malignancy, even if the infection onset was outside the hospital setting, regardless of current HCAI definitions. Outcomes analyses suggest that empiric regimens should routinely contain antianaerobes (except for biliary IAI); however, empiric antienterococcal or antifungals regimens are seldom needed.

Clinical characteristics of Raoultella ornithinolytica bacteremia: a case series and literature review.

Raoultella ornithinolytica is a rare pathogen in human infection and bacteremic cases had been scarcely reported. For further comprehension of the rare infection, we summarized clinical characteristics of 6 cases that were detected at our medical facility and 5 cases from previous literature. The most common infectious focus was biliary infection and elderly patients with a history of any biliary intervention or malignancy were considered to be at a great risk for the infection. The prognosis of the patients was quite satisfactory. Bacterial identification in this report was performed on the basis of biochemical tests alone, and further investigations by molecular analysis are required to confirm our findings.

Calculated Antibiosis of Acute Cholangitis and Cholecystitis.

BACKGROUND: The aim of this article is to present the most recent suggestions for the therapy of acute cholangitis and cholecystitis based on a review of the current literature. METHODS: We performed a systematic literature search in the Medline, PubMed, and Google Scholar databases using the keywords mentioned above. This article is strongly influenced by the publication of the Tokyo Guidelines for the management of acute cholangitis and cholecystitis (TG07, TG13) in 2007 and 2013. These were the first practical guidelines targeting diagnosis and treatment of acute cholangitis and cholecystitis. These guidelines are based on the best published evidence and a consensus conference of international experts in the field. RESULTS AND CONCLUSION: Acute cholangitis and acute cholecystitis are common conditions that may result in progressively severe infection and death when not treated appropriately. Beside supportive therapy and antiobstructive measures, therapy with antimicrobial agents is an important component in the management of affected patients. Here, we discuss the use of antimicrobial agents that are suitable for the first-line management of these infections. Empirical therapy depends upon the knowledge of local microbial epidemiology and patient-specific factors affecting the selection of appropriate agents.

Assessment of Biliary Excretion of Ceftriaxone Sodium in Humans / 医学研究杂志

Objective To study biliary excretion of ceftriaxone sodium in humans. Methods Twelve biliary calculi patients were infused with a single dose of 2.0g ceftriaxone half an hour before operation and the common bile duct bile and gallbladder bile samples were coUected in the operations. The bile drug concentrations were assayed by HPLC. Results The results of clinical study on the bile drug showed that the concentrations (C) of ceftriaxone in common bile duct and gallbladder were (264.43±166.46) μg/ml and (85.39 ±48.16) μg/ml, respectively. Conclusion Ceftriaxone reaches high concentrations in humans' bile, and it could be chosen as a good antibiotics for the treament of biliary infection.