Effectiveness of monthly and bimonthly follow-up of patients with well-controlled type 2 diabetes: a propensity score matched cohort study.

BACKGROUND: On average, patients in Japan with type 2 diabetes mellitus have a clinical consultation every month, although evidence for a favorable follow-up interval is lacking. This study investigated whether the follow-up interval can be extended by comparing the clinical outcomes and cost for monthly versus bimonthly follow-up of patients with well-controlled diabetes mellitus. METHODS: We combined administrative claims data from the National Health Insurance and the Health Checkups Program data of Tsu city, Japan between 2011 and 2014 to conduct a retrospective cohort study of patients with well-controlled type 2 diabetes mellitus. Propensity scores were used to assemble a matched-pairs cohort from patients who had monthly and bimonthly follow-up. Equivalence between two groups was assessed by designating the proportion of patients who maintained good control of their diabetes in the subsequent year as a primary outcome. The proportion achieving target blood pressure and lipid levels, favorable lifestyle, and annual cost were compared as secondary outcomes. RESULTS: Of 12,145 participants, 693 with monthly follow-up and 693 with bimonthly follow-up were matched using propensity scores. In the monthly follow-up group 654 (94.4%) remained under good diabetic control, versus 658 (95.0%) in the bimonthly group (difference: 0.6%; 95% confidence interval: - 1.8 to 2.9%). All secondary outcomes were equivalent for the monthly and bimonthly follow-up groups except the proportion achieving target blood pressure, the proportion engaging in regular exercise, and annual cost. CONCLUSIONS: For patients with well-controlled diabetes mellitus, although frequent follow-up by a physician does not affect the control of blood glucose level in the subsequent year, the annual treatment cost becomes much higher. We suggest that patients with well-controlled diabetes can be followed up less often.

Early diagnosis of pancreatic necrosis based on perfusion CT to predict the severity of acute pancreatitis.

BACKGROUND: Perfusion CT can diagnose pancreatic necrosis in early stage of severe acute pancreatitis, accurately. However, no study to date has examined whether early diagnosis of pancreatic necrosis is useful in predicting persistent organ failure (POF). METHODS: We performed a multi-center prospective observational cohort study to investigate whether perfusion CT can predict the development of POF in the early stage of AP, based on early diagnosis of the development of pancreatic necrosis (PN). From 2009 to 2012, we examined patients showing potential early signs of severe AP (n = 78) on admission. Diagnoses for the development of PN were made prospectively by on-site physicians on the admission based on perfusion CT (diagnosis 1). Blinded retrospective reviews were performed by radiologists A and B, having 8 and 13 years of experience as radiologists (diagnosis 2 and 3), respectively. Positive diagnosis for the development of PN were assumed equivalent to positive predictions for the development of POF. We then calculated the area under the curve (AUC) of the receiver operating characteristic for POF predictions. RESULTS: Fourteen (17.9%) and 23 patients (29.5%) developed PN and POF, respectively. For diagnoses 1, 2, and 3, AUCs for POF predictions were 74, 68, and 73, respectively. CONCLUSIONS: Perfusion CT diagnoses pancreatic necrosis and on that basis predicts the development of POF; http://www.umin.ac.jp/ctr/index-j.htm,UMIN000001926 .

Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015.

BACKGROUND: Japanese (JPN) guidelines for the management of acute pancreatitis were published in 2006. The severity assessment criteria for acute pancreatitis were later revised by the Japanese Ministry of Health, Labour and Welfare (MHLW) in 2008, leading to their publication as the JPN Guidelines 2010. Following the 2012 revision of the Atlanta Classifications of Acute Pancreatitis, in which the classifications of regional complications of pancreatitis were revised, the development of a minimally invasive method for local complications of pancreatitis spread, and emerging evidence was gathered and revised into the JPN Guidelines. METHODS: A comprehensive evaluation was carried out on the evidence for epidemiology, diagnosis, severity, treatment, post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis and clinical indicators, based on the concepts of the GRADE system (Grading of Recommendations Assessment, Development and Evaluation). With the graded recommendations, where the evidence was unclear, Meta-Analysis team for JPN Guidelines 2015 conducted an additional new meta-analysis, the results of which were included in the guidelines. RESULTS: Thirty-nine questions were prepared in 17 subject areas, for which 43 recommendations were made. The 17 subject areas were: Diagnosis, Diagnostic imaging, Etiology, Severity assessment, Transfer indication, Fluid therapy, Nasogastric tube, Pain control, Antibiotics prophylaxis, Protease inhibitor, Nutritional support, Intensive care, management of Biliary Pancreatitis, management of Abdominal Compartment Syndrome, Interventions for the local complications, Post-ERCP pancreatitis and Clinical Indicator (Pancreatitis Bundles 2015). Meta-analysis was conducted in the following four subject areas based on randomized controlled trials: (1) prophylactic antibiotics use; (2) prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis; (3) prophylactic non-steroidal anti-inflammatory drugs (NSAIDs) for the prevention of post-ERCP pancreatitis; and (4) peritoneal lavage. Using the results of the meta-analysis, recommendations were graded to create useful information. In addition, a mobile application was developed, which made it possible to diagnose, assess severity and check pancreatitis bundles. CONCLUSIONS: The JPN Guidelines 2015 were prepared using the most up-to-date methods, and including the latest recommended medical treatments, and we are confident that this will make them easy for many clinicians to use, and will provide a useful tool in the decision-making process for the treatment of patients, and optimal medical support. The free mobile application and calculator for the JPN Guidelines 2015 is available via http://www.jshbps.jp/en/guideline/jpn-guideline2015.html.

Supplier-Induced Demand for Chronic Disease Care in Japan: Multilevel Analysis of the Association between Physician Density and Physician-Patient Encounter Frequency.

BACKGROUND: There are currently large regional variations in the frequency of physician-patient encounters for the treatment of chronic lifestyle diseases in Japan. These variations may be influenced by competition among physicians, and supplier-induced demand (SID) in health care can occur when physicians manipulate their patients' demand for medical services to increase the use of health care. OBJECTIVES: To analyze patient data to investigate the presence of SID in the treatment of chronic diseases at the regional level in Japan. METHODS: We tested the hypothesis that clinic and hospital physicians in areas of high competition (high physician density) are more likely to recommend a sooner follow-up consultation than do those in areas of lower competition (lower physician density). Using random-effects multilevel models, we analyzed patient survey data and administrative claims data to estimate the effects of physician density on encounter frequency and medical charges. In the analysis of claims data, we used the mean drug administration period as a proxy for the frequency of physician-initiated encounters. RESULTS: Our analysis showed that encounter frequency was significantly associated with clinic physician density, but there were no consistent associations with hospital physician density. Increases in physician density were significantly associated with increases in both clinic and hospital medical charges, and these associations were independent from encounter frequency. CONCLUSIONS: The results of our study indicate the presence of SID in Japan. Further studies should investigate whether more frequent physician-patient encounters provide clinical advantages to patients.

Factors associated with prolonged length of hospital stay of elderly patients in acute care hospitals in Japan: a multilevel analysis of patients with femoral neck fracture.

OBJECTIVE: To analyze possible factors associated with prolonged length of stay (LOS) in hip fracture patients in Japan, such as the availability of beds in medical and nursing care facilities at the community level, as well as patient factors, clinical factors and hospital structural characteristics. METHODS: The sample for analysis consisted of 8318 hip fracture cases from 199 hospitals throughout Japan. We conducted multilevel analyses to investigate whether LOS and the discharge destinations of patients are associated with the availability and utilization of medical and nursing care resources in the communities where each hospital is located. RESULTS: After adjusting for patient factors, clinical factors and hospital structural characteristics, a higher number of long-term care beds at the community level was observed to be significantly correlated with both shorter LOS and increased rate of discharge to other facilities. DISCUSSION AND CONCLUSION: Although the Japanese government is attempting to reduce acute care hospital LOS and the number of long-term care beds in order to reduce health care costs, the results of this study suggest that a reduction in the number of long-term care beds would not necessarily reduce the LOS of acute care hospitals, and may instead exacerbate the problem.

Effects of the per diem prospective payment system with DRG-like grouping system (DPC/PDPS) on resource usage and healthcare quality in Japan.

OBJECTIVES: In 2003, Japan introduced the prospective payment system (PPS) with diagnosis-related groups (DRG) rearranged grouping system called the diagnostic procedure combination/per-diem payment system (DPC/PDPS). Even after eight years, little is known about the effects of DPC/PDPS. The purpose of this study was to examine the effects of DPC/PDPS on resource usage and healthcare quality. METHODS: Using 2001-2009 (fiscal year) administrative data of acute myocardial infarction patients, four indices, including inpatient total accumulated medical charges, length of stay (LOS), mortality rate, and readmission rate, were compared between patients reimbursed by DPC/PDPS or by fee-for-service. RESULTS: DPC/PDPS significantly reduced total accumulated medical charges by $1061 (95% confidence interval [CI], -2007, -116) and LOS by 2.29 days (95% CI, -3.71, -0.88) after risk adjustment. However, mortality rate (Odds ratio [OR], 0.94; 95% CI, 0.73, 1.21) was unchanged. Furthermore, DPC/PDPS increased the readmission rate (OR, 1.37; 95% CI, 1.03, 1.82). CONCLUSIONS: This study showed that DPC/PDPS was associated with reduced resource usage, but not improved healthcare quality, as with DRG/PPSs in other countries. To achieve successful healthcare reform, further discussion on additional motives will be required.

Healthcare-associated infections in acute ischaemic stroke patients from 36 Japanese hospitals: risk-adjusted economic and clinical outcomes.

BACKGROUND: Healthcare-associated infections are a major cause for worsening in ischaemic stroke patients. In addition to increased morbidity and mortality, healthcare-associated infections also result in a potentially preventable increase in economic costs. AIMS: The aim of this study was to identify healthcare-associated infection incidence in ischaemic stroke patients in Japanese hospitals, and to conduct a risk-adjusted analysis of the associated economic and clinical outcomes. METHODS: Healthcare-associated infections were identified in 36 Japanese hospitals using an administrative database. Identification was carried out using a combination of International Classification of Diseases-10 codes and antibiotic utilisation patterns that indicated the presence of an infection. Risk-adjusted hospital charges and length of stay were calculated using multiple linear regression analyses correcting for patient and hospital factors. A logistic regression model was used to analyse the association between healthcare-associated infection infection and mortality. RESULTS: There was an overall healthcare-associated infection incidence of 16·4%, with an interhospital range of 4·7-28·3%. After risk-adjustment, infected cases paid an additional US$3,067 per admission (interhospital range US$434-US$7,151) and were hospitalised for an additional 16·3-days (interhospital range: 5·1-25·1-days) when compared with uninfected patients. Healthcare-associated infections also had a strongly significant association with increased mortality (odds ratio=23·2, 95% confidence intervals: 12·5-43·2). CONCLUSIONS: We observed a wide range of healthcare-associated infection incidence between the hospitals. Healthcare-associated infections were found to be significantly associated with increased hospital charges, length of stay, and mortality. Furthermore, the use of risk-adjusted multi-institutional comparisons allowed us to analyse individual performance levels in both infection and cost control.

Verification bias in assessment of the utility of MRI in the diagnosis of cruciate ligament tears.

OBJECTIVE: The purpose of this study was to investigate the extent to which verification bias affects the sensitivity and specificity of MRI in the diagnosis of cruciate ligament tears. MATERIALS AND METHODS: Consecutively registered outpatients who underwent MRI evaluation of the knee were included in the study. The sensitivity and specificity of MRI were calculated for patients whose diagnosis was verified with arthroscopy. For patients who did not undergo arthroscopy, the effect of verification bias was estimated with global sensitivity analysis, a technique of graphic representation of whether a particular combination of sensitivity and specificity estimates is compatible with the observed data. RESULTS: Among the 356 patients included in the study, 82 patients (23%) had the MRI findings verified at arthroscopy. The sensitivity and specificity of MRI among patients who underwent arthroscopy were 38% and 90%. For patients whose disease status was not verified with arthroscopy, the influence of verification bias was estimated with global sensitivity analysis. The sensitivity of MRI ranged from 3% to 73%, and the specificity from 63% to 98%. The region comprising all possible combinations of sensitivity and specificity had a butterfly shape. The sensitivity and specificity pair estimated from cases verified with arthroscopy was included in this region. CONCLUSION: Verification bias did not greatly affect assessment of the diagnostic utility of MRI in the evaluation of cruciate ligament tears. The high specificity previously reported for MRI can be considered valid, but the sensitivity may not be as reliable.

An outcome prediction model for adult intensive care.

OBJECTIVE: To develop a prediction model of 28-day mortality in adult intensive care units using administrative data. DESIGN, SETTING AND PARTICIPANTS: We obtained data from 33 ICUs in Japan on all adult patients discharged from ICUs in 2007. Three predictive models were developed using (i) the five variables of the Critical Care Outcome Prediction Equation (COPE) model (age, unplanned admission, mechanical ventilation, hospital category and primary diagnosis) (the C model); (ii) 11 variables, including the COPE variables and six additional variables (sex, reason for ICU entry, time between hospital admission and ICU entry, use of fresh frozen plasma or a platelet preparation, dialysis, and use of pressors/vasoconstrictors (the P+ model); and (iii) ten of the 11 variables, excluding primary diagnosis (the P- model). Data for 6758 patients were stratified at the hospital level and randomly divided into test and validation datasets. Using the test dataset, five, 10 or nine variables were subjected to multiple logistic regression analysis (sex was excluded [P > 0.05]). MAIN OUTCOME MEASURE: Mortality at 28 days after the first ICU day. RESULTS: Areas under the Receiver Operating Characteristic curve (AUROCs) for the test dataset in the C, P+ and P- models were 0.84, 0.89 and 0.87, respectively. Predicted mortality for the validation dataset gave Hosmer-Lemeshow chi2 values of 12.91 (P = 0.12), 10.76 (P = 0.22) and 13.52 (P = 0.1), respectively, and AUROCs of 0.84, 0.89 and 0.90, respectively. CONCLUSIONS: Our P- model is robust and does not depend on disease identification. This is an advantage, as errors can arise in coding of primary diagnoses. Our model may facilitate mortality prediction based on administrative data collected on ICU patients.

Risk-adjusted increases in medical resource utilization associated with health care-associated infections in gastrectomy patients.

RATIONALE, AIMS AND OBJECTIVES: Quantifying the impact of health care-associated infections (HAIs) on medical resource utilization is necessary for payers and providers to appropriately allocate limited resources for interventions. However, previous studies tend to involve single institutions and do not take into account patient and practice variations between several hospitals. The objective of this study was to conduct a multi-institutional risk-adjusted comparison of HAI-associated impact on medical resources in gastrectomy patients in Japan. METHODS: Health care-associated infections were identified using a combination of International Classification of Diseases-10 codes and antibiotic utilization patterns in 1058 gastrectomy patients from 10 Japanese hospitals. Multiple linear regression models and risk adjustment were used to analyse the impact of HAIs on: (1) total hospital costs; (2) antibiotic costs; and (3) post-surgical length of stay (LOS). RESULTS: Overall HAI incidence for the database was 20.3%, with a range of 8.8-29.6% among the 10 hospitals. Regression models showed that HAIs were significantly associated with increases in all three indicators. Risk-adjusted comparisons revealed that HAIs were associated with an increase of US$2767 (range: US$1035-6513) in overall hospital cost, US$202 (US$98.8-764.6) antibiotic costs and 10.6 (4.7-24 days) post-surgical LOS days. CONCLUSIONS: Even after adjusting for patient characteristics and other variables, there was still a high degree of variation observed in the impact of HAIs on total hospital costs and antibiotic costs from a third-party payer's perspective and post-surgical LOS among the 10 hospitals. This information can increase the efficiency of allocation of resources for interventions to reduce HAIs.

Cutting-edge information for the management of acute pancreatitis.

Considering that the Japanese (JPN) guidelines for the management of acute pancreatitis were published in Takada et al. (J HepatoBiliary Pancreat Surg 13:2-6, 2006), doubts will be cast as to the reason for publishing a revised edition of the Guidelines for the management of acute pancreatitis: the JPN guidelines 2010, at this time. The rationale for this is that new criteria for the severity assessment of acute pancreatitis were made public on the basis of a summary of activities and reports of shared studies that were conducted in 2008. The new severity classification is entirely different from that adopted in the 2006 guidelines. A drastic revision was made in the new criteria. For example, about half of the cases that have been assessed previously as being 'severe' are assessed as being 'mild' in the new criteria. The JPN guidelines 2010 are published so that consistency between the criteria for severity assessment in the first edition and the new criteria will be maintained. In the new criteria, severity assessment can be made only by calculating the 9 scored prognostic factors. Severity assessment according to the contrast-enhanced computed tomography (CT) grade was made by scoring the poorly visualized pancreatic area in addition to determining the degree of extrapancreatic progress of inflammation and its extent. Changes made in accordance with the new criteria are seen in various parts of the guidelines. In the present revised edition, post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis is treated as an independent item. Furthermore, clinical indicators (pancreatitis bundles) are presented to improve the quality of the management of acute pancreatitis and to increase adherence to new guidelines.

Pancreatitis bundles.

Clinical indicators set forth in the guidelines have been found to contribute to the improvement in compliance with the guidelines. On the other hand, it has been shown that clinical indicators are more effective when individual indicators are presented in the form of a bundle than when they are given separately. Accordingly, in the JPN Guidelines 2010 for management of acute pancreatitis, those indicators that are judged to be important on the basis of a recommendation classification of "A or B" are presented as a pancreatitis bundle. Each item includes assessment of severity after a diagnosis of pancreatitis has been made, differentiation of pathogenesis, management of gallstone-induced pancreatitis, a sufficient dose of fluid replacement and monitoring, pain control, prophylactic administration of wide-spectrum antibiotics and cholecystectomy following resolution of pancreatic symptoms caused by cholecystolithiasis. Hereafter, the efficacy of these indicators and the significance of their achievement should be examined carefully. Then, the assessment of the compliance rate with the guidelines as well as the assessment of the guidelines and pancreatitis itself should become possible.

Post-ERCP pancreatitis.

Pancreatitis remains the most common severe complication of endoscopic retrograde cholangiopancreatography (ERCP). Detailed information about the findings of previous studies concerning post-ERCP pancreatitis has not been utilized sufficiently. The purpose of the present article was to present guidelines for the diagnostic criteria of post-ERCP pancreatitis, and its incidence, risk factors, and prophylactic procedures that are supported by evidence. To achieve this purpose, a critical examination was made of the articles on post-ERCP pancreatitis, based on the data obtained by research studies published up to 2009. At present, there are no standardized diagnostic criteria for post-ERCP pancreatitis. It is appropriate that post-ERCP pancreatitis is defined as acute pancreatitis that has developed following ERCP, and its diagnosis and severity assessment should be made according to the diagnostic criteria and severity assessment of the Japanese Ministry of Health, Labour and Welfare. The incidence of acute pancreatitis associated with diagnostic and therapeutic ERCP is 0.4-1.5 and 1.6-5.4%, respectively. Endoscopic papillary balloon dilation is associated with a high risk of acute pancreatitis compared with endoscopic sphincterotomy. It was made clear that important risk factors include dysfunction of the Oddi sphincter, being of the female sex, past history of post-ERCP pancreatitis, and performance of pancreaticography. Temporary prophylactic placement of pancreatic stents in the high-risk group is useful for the prevention of post-ERCP pancreatitis [odds ratio (OR) 3.2, 95% confidence interval (CI) 1.6-6.4, number needed to treat (NNT) 10]. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with a reduction in the development of post-ERCP pancreatitis (OR 0.46, 95% CI 0.32-0.65). Single rectal administration of NSAIDs is useful for the prevention of post-ERCP pancreatitis [relative risk (RR) 0.36, 95% CI 0.22-0.60, NNT 15] and decreases the development of pancreatitis in both the low-risk group (RR 0.29, 95% CI 0.12-0.71) and the high-risk group (RR 0.40, 95% CI 0.23-0.72) of post-ERCP pancreatitis. As for somatostatin, a bolus injection may be most useful compared with short- or long-term infusion (OR 0.271, 95% CI 0.138-0.536, risk difference 8.2%, 95% CI 4.4-12.0%). The usefulness of gabexate mesilate was not apparent in any of the following conditions: acute pancreatitis (control 5.7 vs. 4.8% for gabexate mesilate), hyperamylasemia (40.6 vs. 36.9%), and abdominal pain (1.7 vs. 8.9%). Formulation of diagnostic criteria for post-ERCP pancreatitis is needed. Temporary prophylactic placement of pancreatic stents in the high-risk group offers the most promise as a means of preventing post-ERCP pancreatitis. As for pharmacological attempts, there are high expectations concerning NSAIDs because they are excellent in terms of cost-effectiveness, ease of use, and safety. There was no evidence of effective prophylaxis with the use of protease inhibitors, especially gabexate mesilate.

Treatment strategy for acute pancreatitis.

When a diagnosis of acute pancreatitis (AP) is made, fundamental medical treatment consisting of fasting, intravenous (IV) fluid replacement, and analgesics with a close monitoring of vital signs should be immediately started. In parallel with fundamental medical treatment, assessment of severity based on clinical signs, blood test, urinalysis and imaging tests should be performed to determine the way of treatment for each patient. A repeat evaluation of severity is important since the condition is unstable especially in the early stage of AP. At the time of initial diagnosis, the etiology should be investigated by means of blood test, urinalysis and diagnostic imaging. If a biliary pancreatitis accompanied with acute cholangitis or biliary stasis is diagnosed or suspected, an early endoscopic retrograde cholangiopancreatography with or without endoscopic sphincterotomy (ERCP/ES) is recommended in addition to the fundamental medical treatment. In mild cases, the fundamental medical treatment should be continued until clinical symptom is subsided with normal laboratory data. In cases with severe acute pancreatitis (SAP) referral should be considered to medical centers experienced in the treatment of SAP, and intensive care is recommended for preventing both organ failures and infectious complications. Hemodynamic stabilization with vigorous fluid resuscitation, respiratory support and antibiotics are the major parts of intensive care in the early period of SAP. Continuous hemodiafiltration (CHDF) and continuous regional arterial infusion (CRAI) of protease inhibitor and/or antibiotics may be effective to improve pathophysiology of AP especially in the early stage of the disease. In the late stage of AP, infectious complications are critical. If an infectious complication is suspected based on clinical signs, blood test and imaging, a fine needle aspiration (FNA) is recommended to establish a diagnosis. The accuracy of FNA is reported to be 89 ~ 100%. For patients with sterile pancreatitis, non-surgical treatment should be indicated. For patients with infected pancreatic necrosis, therapeutic intervention either by percutaneous, endoscopic, laparoscopic or surgical approach are indicated. The most preferred surgical intervention is necrosectomy, however, non-surgical treatment with antibiotics is still the treatment of choice if the general condition is stable. Necrosectomy should be performed as late as possible. For patients with pancreatic abscess, drainage is recommended.

Health insurance and payment systems for severe acute pancreatitis.

The medical insurance system of Japan is based on the Universal Medical Care System guaranteed by the provision of the Article 25 of the Constitution of Japan, which states that "All the people shall have the right to live a healthy, cultural and minimum standard of life." The health insurance system of Japan comprises the medical insurance system and the health care system for the long-lived. Medical care insurance includes the employees' health insurance (Social Insurance) that covers employees of private companies and their families and community insurance (National Health Insurance) that covers the self-employed. Each medical insurance system has its own medical care system for the retired and their families. The health care system for the long-lived covers people of over 75 years of age (over 65 years in people with a certain handicap). There is also a system under which all or part of the medical expenses is reimbursed by public expenditure or the cost of medical care not covered by health insurance is paid by the government. This system is referred to collectively as the "the public payment system of medical expenses." To support the realization of the purpose of this system, there is a treatment research enterprise for specified diseases (intractable diseases). Because of the high mortality rate, acute pancreatitis is specified as an intractable disease for the purpose of reducing its mortality rate, and treatment expenses of patients are paid in full by the government dating back to the day when the application was made for a certificate verifying that he or she has severe acute pancreatitis.

New diagnostic criteria of acute pancreatitis.

Practical guidelines for the diagnosis of acute pancreatitis are presented so that a rapid and adequate diagnosis can be made. When acute pancreatitis is suspected in patients with acute onset of abdominal pain and tenderness mainly in the upper abdomen, the diagnosis of acute pancreatitis is made on the basis of elevated levels of pancreatic enzymes in the blood and/or urine. Furthermore, other acute abdominal diseases are ruled out if local findings associated with pancreatitis are confirmed by diagnostic imaging. According to the diagnostic criteria established in Japan, patients who present with two of the following three manifestations are diagnosed as having acute pancreatitis: characteristic upper abdominal pain, elevated levels of pancreatic enzymes, and findings of ultrasonography (US), CT or MRI suggesting acute pancreatitis. Detection of elevated levels of blood pancreatic enzymes is crucial in the diagnosis of acute pancreatitis. Measurement of blood lipase is recommended, because it is reported to be superior to all other pancreatic enzymes in terms of sensitivity and specificity. For measurements of the blood amylase level widely used in Japan, it should be cautioned that, because of its low specificity, abnormal high values are also often obtained in diseases other than pancreatitis. The cut-off level of blood pancreatic enzymes for the diagnosis of acute pancreatitis is not able to be set because of lack of sufficient evidence and consensus to date. CT study is the most appropriate procedure to confirm image findings of acute pancreatitis. Elucidation of the etiology of acute pancreatitis should be continued after a diagnosis of acute pancreatitis. In the process of the etiologic elucidation of acute pancreatitis, judgment whether it is gallstone-induced or not is most urgent and crucial for deciding treatment policy including the assessment of whether endoscopic papillary treatment should be conducted or not. The diagnosis of gallstone-induced acute pancreatitis can be made by combining detection of elevated levels of bilirubin, transamylase (ALT, AST) and ALP detected by hematological examination and the visualization of gallstones by US.

Gallstone-induced acute pancreatitis.

In the care of acute pancreatitis, a prompt search for the etiologic condition of the disease should be conducted. A differentiation of gallstone-induced acute pancreatitis should be given top priority in its etiologic diagnosis because it is related to the decision of treatment policy. Examinations necessary for diagnosing gallstone-induced acute pancreatitis include blood tests and ultrasonography. Early ERCP/ES should be performed in patients with gallstone-induced acute pancreatitis if a complication of cholangitis and a prolonged passage disorder of the biliary tract are suspected. The treatment for bile duct stones with the use of ERCP/ES alone is not recommended in cases of gallstone-induced pancreatitis with gallbladder stones. Cholecystectomy for gallstone-induced acute pancreatitis should be performed using a laparoscopic procedure as the first option as soon as the disease has subsided.

Assessment of severity of acute pancreatitis according to new prognostic factors and CT grading.

The assessment of severity at the initial medical examination plays an important role in introducing adequate early treatment and the transfer of patients to a medical facility that can cope with severe acute pancreatitis. Under these circumstances, "criteria for severity assessment" have been prepared in various countries, including Japan, and these criteria are now being evaluated. The criteria for severity assessment of acute pancreatitis in Japan were determined in 1990 (of which a partial revision was made in 1999). In 2008, an overall revision was made and the new Japanese criteria for severity assessment of acute pancreatitis were prepared. In the new criteria for severity assessment, the diagnosis of severe acute pancreatitis can be made according to 9 prognostic factors and/or the computed tomography (CT) grades based on contrast-enhanced CT. Patients with severe acute pancreatitis are expected to be transferred to a specialist medical center or to an intensive care unit to receive adequate treatment there. In Japan, severe acute pancreatitis is recognized as being a specified intractable disease on the basis of these criteria, so medical expenses associated with severe acute pancreatitis are covered by Government payment.