Histopathological diagnosis of Barrett's mucosa and associated neoplasias. Results of a consensus conference of the Working Group for "Gastroenterological Pathology of the German Society for Pathology" on 22 September 2001

There are a number of difficulties regarding the diagnosis of Barrett's mucosa and the varying grades of neoplasia that may be associated with it. It was therefore the aim of a consensus conference of the "Working Group for Gastroenterological Pathology within the German Society of Pathology" to achieve standardization regarding the following issues: definition and diagnostic criteria for Barrett's mucosa and its discrimination from intestinal metaplasia of the cardia, diagnostic criteria for intraepithelial neoplasia, number of biopsies necessary to establish the diagnosis, significance of additional immunohistochemical and/or molecular biological methods as well as importance of a second opinion in the diagnosis of intraepithelial neoplasia.     

Clinicopathological characterization of so-called “cholangiocarcinoma with intraductal papillary growth” with respect to “intraductal papillary neoplasm of bile duct (IPNB)”

Cholangiocarcinoma (CC) of the biliary tract occasionally presents a predominant intraductal papillary growth in the bile ducts, called as biliary tract carcinoma (BTC) of papillary growth (PG) and intrahepatic CC (ICC) of intraductal growth (IG) type. Recently, intraductal papillary neoplasm of bile duct (IPNB) has been proposed as a pre-invasive biliary neoplasm. This study was performed to characterize pathologically BTC of PG type and ICC of IG type with respect to IPNB. It was found that 126 of such 154 CCs (81.8%) fulfilled the criteria of IPNB, while the remaining 28 cases showed different histologies, such as tubular adenocarcinoma and carcinosarcoma. These IPNBs occurred in old aged patients with a male predominance, and the left lobe was rather frequently affected in the liver. A majority of these cases were high grade IPNB (43 cases) and invasive IPNB (77 cases), while low grade IPNB was rare (6 cases). Pancreatobiliary type was predominant (48 cases) followed by gastric (30 cases), intestinal (29 cases) and oncocytic (19 cases) types. Mucus hypersecretion was found in 45 cases, and this was frequent in IPNB at the intrahepatic large bile duct and hilar bile ducts but rare at the extrahepatic bile ducts. Interestingly, 36 cases of high grade and invasive IPNBs contained foci of moderately differentiated adenocacinoma within the intraductal papillary tumor. In conclusion, a majority of ICC of IG type and BTC of PG type could be regarded as a IPNB lineage, and clinically detectable IPNBs were already a malignant papillary lesion.     

A Double-blind Trial of Synthetic Salmon Calcitonin in the Treatment of Acute Pancreatitis

A multicenter randomized double-blind trial on the use of synthetic salmon calcitonin (SCT) was carried out in 94 patients with acute pancreatitis. In addition to strict standard treatment—without aprotinin, atropine, or antacids—50 patients received daily 3 × 20 μg = 300 MRCU SCT intravenously and 44 patients received placebo for 6 days. Mortality rate was not influenced, overall mortality being 5.3%. The number of patients without pain and with normalized serum amylase on a given day was significantly higher in the group treated with SCT. Other parameters such as doses of analgesics, leukocyte count, and normalization of seven defined clinical and laboratory criteria within 6 days showed a positive trend without reaching significance.     

Epoetin delta,erythropoietin produced in a human cell line,in the management of anaemia in predialysis chronic kidney disease patients

ABSTRACT

Objective: To demonstrate safety and efficacy of epoetin delta for the management of anaemia in predialysis patients with chronic kidney disease (CKD).

Research design and methods: This was a multicentre, open-label, uncontrolled study with predialysis CKD patients who had previously received subcutaneous epoetin therapy. Patients were switched to epoetin delta from their previous therapy, at an identical dose. Dose was subsequently titrated to maintain haemoglobin at 10.0–12.0?g/dL. Study duration was 52 weeks.

Main outcome measures: The primary endpoint was average haemoglobin levels over Weeks 12, 16, 20 and 24. Secondary analyses were performed on the proportion of patients with haemoglobin and haematocrit levels over preset target levels, haemoglobin and haematocrit levels through to study end and dosing levels.

Results: Haemoglobin levels were maintained at 11.3 ± 1.2?g/dL over Weeks 12–24. Over 80% of the haemoglobin measurements and 95% of the haematocrit measurements were above the predefined target level (haemoglobin ≥ 10?g/dL; haematocrit ≥ 30%). Weekly dose levels did not change significantly over the course of the trial. Epoetin delta was well tolerated, with adverse events occurring at frequencies expected for this patient population; no patient developed neutralizing anti-erythropoietin antibodies.

Conclusions: Epoetin delta was an effective and well-tolerated agent for the management of anaemia in a subgroup of predialysis CKD patients.     

Once-weekly oral medication with alendronate does not prevent migration of knee prostheses

Background and purpose Early migration of joint replacements is an effect of poor fixation and can predict late loosening. By reducing the bone resorption after implantation of a joint replacement, it should be possible to enhance the initial fixation of the implant. We studied the effect of once-weekly treatment with alendronate after knee replacement.

Patients and methods We recruited 60 patients (60 knees) with gonarthrosis who were scheduled for a total knee replacement. They were operated on with identical implants and uncemented fixation. 30 patients were treated with a bisphosphonate (alendronate) and 30 patients underwent placebo treatment. The treatment started postoperatively and continued on a weekly basis for 6 months. The fixation of the implants was measured with repeated radiostereometry for 2 years.

Results There was no difference in migration of implants between the two groups.

Conclusion With uncemented fixation of knee implants, no benefit of once-weekly treatment with alendronate, starting postoperatively, could be seen during a 2-year follow-up period.     

Nutrient and Fiber Intake and Risk of Renal Cell Carcinoma

This study examines the association between nutrient and fiber intake and the risk of renal cell carcinoma (RCC). Between 1994 and 1997 in 8 Canadian provinces, mailed questionnaires were completed by 1,138 incident, histologically confirmed cases of RCC and 5,039 population controls. Measurement included information on socioeconomic status, lifestyle habits, and diet. A 69-item food frequency questionnaire provided data on eating habits 2 yr before data collection. Odds ratios (ORs) and 95% confidence intervals were derived through unconditional logistic regression. Intakes of total fat, saturated fat, monounsaturated fat, trans-fat, and cholesterol were associated with the risk of RCC; the ORs for the highest vs. the lowest quartile were 1.67, 1.53 and 1.46, 1.31, and 1.48, respectively. The positive association was apparently stronger in women, overweight or obese, and never smokers. Sucrose was related to the risk of RCC. High fiber intake was inversely associated with RCC risk. No association was found with intake of total protein and polyunsaturated fat, n-3 and n-6 polyunsaturated fatty acids, and total carbohydrates. The results were consistent across strata of sex, tobacco, and BMI. The findings suggest that a diet low in fats and cholesterol and rich in fiber could favorably affect the risk of RCC.     

Risk factors associated with the dramatic increase in the prevalence of diabetes in the adult Chinese population in Qingdao,China

Objective To investigate the major risk factors and their association with the dramatic increase in the prevalence of diabetes from 2001–2002 to 2006 in Qingdao, China. Methods Population‐based cross‐sectional studies on diabetes were performed in 4598 men and 7026 women aged 35–74 years. The 2006 World Health Organization diagnostic criteria for diabetes were used. Results The crude prevalence of diabetes was 11.3% in both men and women in urban areas and 5.3% and 8.9% in rural areas in 2001–2002. This increased to 19.2% and 16.1% in urban areas and 14.2% and 13.8% in rural areas in 2006 for men and women, respectively. The increase in diabetes prevalence from 2001–2002 to 2006 was paralleled by an increased body mass index in rural areas but not in urban areas. The major risk factors associated with diabetes were age, family history of diabetes, obesity, hypertension and high triglycerides. The multivariate adjusted odds ratio and 95% confidence interval for diabetes corresponding to a one standard deviation increase in waist circumference was 1.81 (1.47, 2.23) in urban men, 1.64 (1.26, 2.13) in rural men, 1.98 (1.66, 2.37) in urban women and 2.02 (1.63, 2.51) in rural women. Low socio‐economic classes had a higher risk for diabetes in urban areas but a lower risk in rural areas, both associated with increased waist circumference. Conclusion Established risk factors are of great importance for the prevalence of diabetes in the urban and rural Chinese populations and changes in these factors could explain the recent dramatic increase in diabetes prevalence, particularly in rural areas. Considering the high prevalence of obesity and physical inactivity, intervention is urgently required in China.     

Grading quality of evidence and strength of recommendations in clinical practice guidelines: Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies

The GRADE approach to grading the quality of evidence and strength of recommendations provides a comprehensive and transparent approach for developing clinical recommendations about using diagnostic tests or diagnostic strategies. Although grading the quality of evidence and strength of recommendations about using tests shares the logic of grading recommendations for treatment, it presents unique challenges. Guideline panels and clinicians should be alert to these special challenges when using the evidence about the accuracy of tests as the basis for clinical decisions. In the GRADE system, valid diagnostic accuracy studies can provide high quality evidence of test accuracy. However, such studies often provide only low quality evidence for the development of recommendations about diagnostic testing, as test accuracy is a surrogate for patient-important outcomes at best. Inferring from data on accuracy that using a test improves outcomes that are important to patients requires availability of an effective treatment, improved patients' wellbeing through prognostic information, or – by excluding an ominous diagnosis – reduction of anxiety and the opportunity for earlier search for an alternative diagnosis for which beneficial treatment can be available. Assessing the directness of evidence supporting the use of a diagnostic test requires judgments about the relationship between test results and patient-important consequences. Well-designed and conducted studies of allergy tests in parallel with efforts to evaluate allergy treatments critically will encourage improved guideline development for allergic diseases.