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A series of anamnestic, clinical, endoscopic and histologic parameters was evaluated in 64 patients with ulcerative colitis in remission to assess whether any of these had predictive value of relapse. All patients with quiescent disease were followed for at least 6 months. The statistical analysis was carried out by means of likelihood chi 2 test, receiver operating characteristic curve, Youden index and stepwise logistic regression. Eighteen patients out of 64 (28%) had a relapse, in a mean period of 9 months after the beginning of the study. The findings of our study suggest that only three factors were useful in selecting a subpopulation with a higher risk of recurrence: (a) a fiber-poor diet; (b) a number of previous episodes of relapse higher than 10, and (c) the presence of extraintestinal manifestations.

In order to verify the role of CEA in the differential diagnosis of pancreatic cancer and to evaluate some influencing factors like age, tumor spread and liver dysfunction, this antigen was measured in the sera of 60 control subjects, 45 patients with pancreatic cancer, 37 with chronic pancreatitis, 67 with benign, and 28 with malignant extra-pancreatic diseases. CEA was found to be elevated in 23/45 pancreatic cancers, in 8/37 chronic pancreatitis, in 17/67 benign and in 9/28 malignant extra-pancreatic diseases. Significant correlations were documented between CEA and age in all the subjects; between CEA and immunoglobulins G in liver cirrhosis and between CEA and alkaline phosphatase in gastrointestinal extra-pancreatic malignancies. In pancreatic cancer higher CEA levels were detected in patients with metastases. We can conclude that CEA is of limited value in the differential diagnosis of pancreatic cancer; it does not seem to be able to detect early pancreatic tumors. Age and liver dysfunction may contribute towards elevating this marker in serum.

In our study of the effect of acute cimetidine administration on acetaminophen metabolism, 10 healthy subjects were given an oral dose of acetaminophen (1 g) before and after administration of cimetidine (800 mg, po). In another experiment, 10 patients with duodenal ulcer received acetaminophen (1 g, po) before and after 2 months of cimetidine treatment (400 mg twice a day, po). Acetaminophen metabolism in blood and urine was studied for 9 h in each experiment. The half-life of acetaminophen was similar either in the absence or presence of both acute and chronic cimetidine administration. Although acute cimetidine ingestion did not affect acetaminophen urinary excretion, prolonged cimetidine treatment resulted in a slight but significant decrease of acetaminophen mercapturate urinary excretion. These findings suggest that, unlike acute cimetidine, prolonged histamine H2 antagonist therapy inhibits acetaminophen oxidation to its reactive metabolite. The clinical relevance of such an interaction remains to be explored.

Eight cases of early gastric cancer (EGC) (histological diagnosis on the resected specimens) were detected Type III (excavated; seven out of eight cases). In three endoscopies. They constituted 3.3% of the gastric cancers observed (239 cases). The most frequent type of EGC was Type III (excavated: seven out of eight cases). In three patients the diagnosis was made only at a second examination, since the first had been negative for malignancy; at the follow-up examination in these cases, the lesion seemed to have healed. The operation was therefore carried out only on the basis of the histological interpretation of endoscopic biopsies.

In order to assess the value of serum markers and simple clinical data in the differential diagnosis of pancreatic cancer, we studied 32 control subjects and 28 patients with pancreatic cancer, 26 with chronic pancreatitis, and 37 with extra-pancreatic diseases. CA 19-9 was found to be the best marker in detecting pancreatic cancer. Among the clinical data, presence and onset of pain attacks, age, and weight loss were selected as the most informative in assessing chronic pancreatic disease. Clinical data correctly classified 88.5% of chronic pancreatitis and 75.0% of pancreatic cancer; serum markers identified pancreatic tumor in 67.9% of the patients. The adjunct of serum markers to clinical data did not improve accuracy in diagnosing chronic pancreatic disease. Since clinical data and serum markers generally become positive at an advanced stage of the disease, early diagnosis of pancreatic cancer is a goal still to be attained.

Peptic ulcer has been reported with increased frequency in patients with liver cirrhosis, its prevalence ranging form 5% to 20%. The aim of the present study is twofold: 1) to define the frequency of peptic ulcer in chronic liver disease in a large sample of cirrhotic patients, 2) to investigate the epidemiological and clinical features of a group of subjects affected by both peptic ulcer and liver cirrhosis. Two years of admission have been retrospectively investigated to define the frequency of peptic ulcer in chronic liver disease. In 237 subjects affected by both cirrhosis and peptic ulcer, epidemiological and clinical data were collected. Peptic ulcer was present in 16% of cirrhotic patients. There were no differences between ulcer subjects who drank and those did not. A linear positive correlation between smoking habit and frequency of ulcer disease has been found in the words. A positive history for peptic ulcer was described in a little subgroup of the studied sample, suggesting a low importance of the genetic factor in the pathophysiological pattern of ulcer disease in chronic hepatitis.

To identify the independent predictors of hepatic fibrosis in 69 children with nonalcoholic steatohepatitis (NASH) due to nonalcoholic fatty liver disease (NAFLD).All patients with clinically suspected NASH underwent liver biopsy as a confirmatory test. The following clinical and biochemical variables at baseline were examined as likely predictors of fibrosis at histology: age, body mass index (BMI), systolic blood pressure (SBP), dyastolic blood pressure (DBP), fasting glucose, fasting insulin, homeostatic model assessment for insulin resistence (HOMA-IR), cholesterol, tryglicerides, alanine aminotransferase (ALT), aspartate aminotransferase (AST), AST/ALT ratio, gamma glutamil transferase (GT), platelet count, prothrombin time (PT).At histology 28 (40.6%) patients had no fibrosis and 41 (59.4%) had mild to bridging fibrosis. At multivariate analysis, BMI26.3 was the only independent predictor of fibrosis (OR = 5.85, 95% CI = 1.6-21).BMI helps identify children with NASH who might have fibrotic deposition in the liver.

Background: The identification of therapeutic agents that can prevent the pancreatic injury after endoscopic retrograde cholangiopancreatography (ERCP) is of considerable importance. Methods: We performed a meta-analysis including 28 clinical trials on the use of somatostatin (12 studies), octreotide (10 studies), and gabexate mesilate (6 studies) after ERCP. Outcome measures evaluated were the incidence of acute pancreatitis, hyperamylasemia, and pancreatic pain. Three analyses were run separately: for all available studies, for randomized trials only, and for only those studies published as complete reports. Results: When all available studies were analyzed, somatostatin and gabexate mesilate were significantly associated with improvements in all three outcomes. Odds ratios (OR) for gabexate mesilate were 0.27 (95% CI [0.13, 0.57], p = 0.001) for acute pancreatitis, 0.66 (95% CI [0.48, –0.89], p = 0.007) for hyperamylasemia, and 0.33 (95% CI [0.18, 0.58], p = 0.0005) for post-procedural pain. Somatostatin reduced acute pancreatitis (OR 0.38: 95% CI [0.22, 0.65], p p p = 0.008). Octreotide was associated only with a reduced risk of post-ERCP hyperamylasemia (OR 0.51: 95% CI [0.31, 0.83], p = 0.007) but had no effect on acute pancreatitis and pain. The statistical significance of data did not change after analyzing randomized trials only or studies published as complete reports. For each considered outcome, the publication bias assessment and the number of patients that need to be treated to prevent one adverse effect were, respectively, higher and lower for somatostatin than for gabexate mesilate. Conclusions: The pancreatic injury after ERCP can be prevented with the administration of either somatostatin or gabexate mesilate, but the former agent is more cost-effective. Additional studies comparing the efficacy of short-term infusion of somatostatin versus gabexate mesilate in patients at high risk for post-ERCP complications seem warranted. (Gastrointest Endosc 2000;51:1-7.)

There have been few trials comparing the efficacy of determinations of cholesterol, fibronectin and triglycerides for diagnosis of malignant ascites. In this study we measured these in 200 ascitic fluids from 93 cirrhotic patients (Group A), 47 hepatocellular-carcinoma patients (Group B), 60 extra-hepatic tumour patients (Group C), 44 of them with malignant cells (Group Cpos) and 16 without (Group Cneg). Anova one-way and the Bonferroni test for multiple comparisons showed that fibronectin and cholesterol were significantly higher in the ascitic fluids of patients of group C than of groups A and B (mean +/- ESM) (Cholesterol in A: 27.2 +/- 2.8; in B 23.5 +/- 1.5; in C: 68.6 +/- 5.3 mg/dl. Fibronectin in A: 32.7 +/- 2.8; in B 31.3 +/- 2.6; in C 127.7 +/- 11.1 mg/l). Both were significantly higher in Group Cpos than in Group Cneg (Cholesterol in Cneg: 41.2 +/- 6.7; in Cpos: 78.6 +/- 6.2 mg/dl. Fibronectin in Cneg: 55.0 +/- 11.2; in Cpos 154 +/- 12.3 mg/dl). We found no differences between cirrhotic ascites and malignant ascites due to primary liver hepatocellular-carcinoma. No difference at all in triglycerides were detected. With the Receiver-Operating Characteristic (ROC) curve, cholesterol had the best Youden Index (57%) at a cut-off of 32 mg/dl (sensitivity 78.3%, specificity 79.3% at this level); the best Youden Index (64%) for fibronectin had a cut-off of 60 mg/dl (sensitivity 65%, specificity 89.3%). Triglycerides appeared to be a great deal less effective as a diagnostic marker, with their best Youden Index (23%) at a cut-off 32 mg/dl (sensitivity 66.7%, specificity 56.4%).(ABSTRACT TRUNCATED AT 250 WORDS)

With a view to describing the natural history of duodenal ulcer, currently linked with powerful and widely used drugs, we retrospectively reviewed all patients followed-up at our unit between 1978 and 1989. All DU subjects with at least 5 years of clinical-endoscopic follow-up were admitted to the study. Concomitant gastric ulcer, previous gastrointestinal surgery and treatment other than with H2-blockers (where necessary) were considered exclusion criteria. Forty-four patients (35 males, 9 females, mean age 44.5) proved eligible for this study. At monthly intervals in the patients' history of ulcer disease (starting from a baseline month 0 when ulcer symptoms first appeared), we compared all cases in which the duration of disease coincided, i.e. for each month of the clinical course of the ulcer there was a certain number of patients at the same point in time; patients' histories coincided variously over a period ranging from 0 to 15 years. We considered endoscopically-diagnosed relapses (both symptomatic and asymptomatic) and hemorrhages as marker events for the activity of DU disease. A year-by-year duodenal ulcer activity rate was obtained for both treated and untreated subjects, as follows: No. of events/mean No. of patients followed-up per month x 100. Fisher's exact test and multivariate analysis (stepwise logistic regression) were used to investigate risk factors of poor outcome. We found that the years between the 1st and 5th and between the 10th and 15th from the onset of duodenal ulcer disease had higher peaks of activity, mostly in untreated subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

Hepatoblastoma (HB) is the most frequent malignant liver tumor in infancy, and both its biological features and its prognostic behavior are still under investigation. DNA content and proliferative activity of the tumor have been considered as biological parameters related to the tumor's aggressiveness. The present study attempts to investigate the possible association between histologic subtype, DNA content, and proliferative indices in HB. DNA content and the proportion of cells in the S-phase were assessed by flow cytometry in 34 cases of HB (14 prior to chemotherapy, 20 after chemotherapy), using formalin-fixed, paraffin-embedded archival samples. The proliferative cell nuclear antigen (PCNA) labeling index was also evaluated by immunohistochemistry, and both the flow cytometry (FC) and the immunohistochemical data were correlated with tumor pathology. A significant association was found between histological type, DNA content and the percentage of cells in the S-phase, with aneuploidy and the highest proportions of S-phase cells significantly associated with embryonal tumors. The PCNA labeling index was found to be significantly higher in embryonal than in fetal phenotype. The biological heterogeneity of HB is confirmed by the different nuclear content of the fetal (diploid) and embryonal (aneuploid) epithelial components of the tumor, also ruling out the likelihood of fetal (diploid) clones deriving from the embryonal (aneuploid) neoplastic cells. Since the highly proliferative neoplastic clones (i.e., embryonal) are thought to be more sensitive to antimitotic drugs, further studies are indicated to determine the relationship between ploidy, proliferative indices and chemoresponsiveness.

OBJECTIVES: Eradication rates with triple therapy (TT) for Helicobacter pylori infection have declined to unacceptable levels. Sequential therapy (ST) is a novel treatment that has shown promise in several controlled trials. Our aim was to assess the efficacy of ST in adults and children compared with that of TT by performing a systematic review and meta-analysis. METHODS: We performed an electronic search of the following: Cochrane Trial Register (until Issue 4, 2008), MEDLINE (1966 to 21 October 2008), EMBASE (1980 to 21 October 2008), and abstracts from the major US, European, and Asian gastroenterology conferences. Randomized controlled trials (RCTs) and controlled clinical trials with a parallel group design comparing the ST with a TT lasting at least 7 days were used. RESULTS: Ten RCTs enrolled 3,006 adult patients and the odds ratio (OR) for eradication of H. pylori with ST compared with TT was 2.99 (95% confidence interval (CI): 2.47-3.62), giving a number needed to treat (NNT) of 6 (95% CI: 5-7) favoring ST. There was no publication bias. The OR for eradication with ST compared with 10-day TT was 2.92 (95% CI: 1.95-4.38), yielding an NNT of 8 (95% CI: 6-12), favoring ST. In patients with clarithromycin resistance, the OR for eradication with ST was 10.21 (95% CI: 3.01-34.58) compared with TT, but the numbers studied are small. Three RCTs enrolled 260 children and adolescents, and the OR for eradication was 1.98 (95% CI: 0.96-4.07). There was no difference in the rate of side effects between the ST and the TT (OR, 1.01; 95% CI: 0.78-1.30). CONCLUSIONS: ST appears to be better than TT in the eradication of H. pylori. This is a promising therapy, but further trials are needed in other European countries and North America before it can be recommended as a first-line treatment.

In this paper the clinical usefulness of CEA and ferritin in the diagnosis of pancreatic cancer was pointed out. CEA was found to be increased in 51% of patients with pancreatic cancer; it was also abnormal in 22% of chronic pancreatitis and 31% of extra-pancreatic diseases. In patients with metastatic pancreatic cancer CEA was found to be more elevated than in those with localized tumor. CEA correlated with the age of the subjects in all material; in liver cirrhosis with IgG and in extra-pancreatic gastro-intestinal malignancies with alkaline-phosphatase. Ferritin was found to be increased in 73% of pancreatic cancer patients; it was also abnormal in 40% of chronic pancreatitis and in 38% of extra-pancreatic diseases. Patients with chronic pancreatitis studied during a relapsing phase all had elevated serum ferritin. We can conclude that neither CEA nor ferritin are useful indices of pancreatic malignancy, due to the lack of sensitivity or specificity. Both are influenced by several factors: CEA mainly by age and liver dysfunction, ferritin by the presence of an acute inflammation with cell necrosis.

AIM: To evaluate the gastric permeability after both acute and chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) and to assess the clinical usefulness of sucrose test in detecting and following NSAIDs- induced gastric damage mainly in asymptomatic patients and the efficacy of a single pantoprazole dose in chronic users. METHODS: Seventy-one consecutive patients on chronic therapy with NSAIDs were enrolled in the study and divided into groups A and B (group A receiving 40 mg pantoprazole daily, group B only receiving NSAIDs). Sucrose test was performed at baseline and after 2, 4 and 12 wk, respectively. The symptoms in the upper gastrointestinal tract were recorded. RESULTS: The patients treated with pantoprazole had sucrose excretion under the limit during the entire follow-up period. The patients without gastroprotection had sucrose excretion above the limit after 2 wk, with an increasing trend in the following weeks (P = 0.000). A number of patients in this group revealed a significantly altered gastric permeability although they were asymptomatic during the follow-up period. CONCLUSION: Sucrose test can be proposed as a valid tool for the clinical evaluation of NSAIDs- induced gastric damage in both acute and chronic therapy. This tecnique helps to identify patients with clinically silent gastric damages. Pantoprazole (40 mg daily) is effective and well tolerated in chronic NSAID users.

To evaluate the effect of Helicobacter pylori infection on the prevalence and severity of non-steroidal anti-inflammatory drug (NSAID)-related upper gastrointestinal lesions in the elderly.One hundred and twenty-eight symptomatic NSAID users (47 males, 81 females; mean age 79.5 years, range 67-95 years) were evaluated by endoscopy. NSAID use was evaluated at the time of endoscopy by interview and general practitioners' clinical records. Patients were separated by the following use patterns: (1) Occasional Users: patients who had taken NSAIDs sporadically, on an as-needed basis in the 7-day period before endoscopy; (2) Acute Users: patients who had taken NSAIDs regularly during the last month; and (3) Chronic Users: patients who had taken NSAIDs regularly for more than 1 month. H. pylori infection was diagnosed by gastric histology (modified Giemsa stain) and the rapid urease test. Statistical analysis was performed by means of the chi 2 test with standardized deviates.Of the 128 subjects, 107 (83.6%) presented with gastroduodenal damage: 3 patients (2.3%) had erosive oesophagitis; 38 patients (29.7%) had gastric ulcer (GU); 43 patients (33.6%) had duodenal ulcer (DU); 3 patients (2.3%) had both GU and DU and 20 patients (15.6%) had erosive gastritis. Seventy-four of the 128 patients (57.8%) were found to be H. pylori positive. In comparison to H. pylori-negative subjects, those who were H. pylori-positive had a significantly higher percentage of GU and DU (74.3% vs. 53.7%, P = 0.02) and a lower percentage of non-gastroduodenal lesions (10.8% vs. 24.0%, P = 0.05). No significant trend in H. pylori positivity was found in the 50/128 (39.06%) patients who presented with bleeding lesions (H. pylori positive 36.5%, H. pylori negative 42.6%, not significant). At endoscopy 78% of occasional NSAID users, 93.8% of acute users and 88.7% of chronic users presented with upper gastrointestinal lesions (not significant). No significant differences in NSAID use patterns were observed between H. pylori-positive and H. pylori-negative subjects.H. pylori infection in the elderly is associated with an increase in the NSAID-related GU and DU, but not with a higher prevalence of upper gastrointestinal bleeding.

Is it useful to have a statistician in a research group? Is it sufficient to rely on the statistician for the data analysis? These and other questions on this subject will be discussed and although the answers can seem obvious, reality is often different. This is not a complete treatise but only the beginning of a discussion.

A substantial number of duodenal ulcer (DU) patients relapse despite maintenance treatment with antisecretory drugs. The influence of certain risk factors and the heterogeneity of the disease could explain such behavior. The present prospective, open study compares the one-year clinical outcome (with upper GI endoscopy at the beginning of the study, at 6 and 12 months, and at every symptomatic relapse) of four groups of DU subjects, consecutively recruited from December 1987 to December 1988, separated in accordance with whether or not a bleeding DU episode had previously occurred, and whether or not an evaluation of gastric acid secretion had been made. Thus, Group I (17 patients; 12 males, 5 females) included heavy smokers and/or gastric acid hypersecretors; Group II (13 patients; 12 males, 1 female) non- or light smokers non-hypersecretors; Group III (34 patients; 22 males, 12 females) subjects with unknown gastric acid secretion; Group IV (33 patients; 30 males, 3 females) previously bleeding DU patients. All patients, except those in Group II (who were left untreated), were given ranitidine 150 mg at bedtime. The outcome of Groups I+II was compared with that of Group III (considered as "standard therapy") and Group IV patients, the latter presumably with a low risk of relapse because of the low prevalence of smokers.Chi-square test, Fisher's exact test, analysis of variance and the logrank test. During the year of follow-up, 27/97 patients withdrew from the study, while 18 had a DU relapse (remission rates 82.1% +/- 7.4% in Groups I+II, 70.5% +/- 8.4% in Group III, 87.5% +/- 5.9% in Group IV).(ABSTRACT TRUNCATED AT 250 WORDS)

In humans, the role of liver cell dysplasia as a preneoplastic lesion is still debated. A prospective, long-term, multicenter study was performed to establish whether liver cell dysplasia in cirrhosis is associated with an increased risk for hepatocellular carcinoma (HCC).A cohort of 307 consecutive patients in whom liver cirrhosis was diagnosed by histology was investigated for development of HCC at 6-month intervals by ultrasonography and determination of alpha-fetoprotein levels.At enrollment, liver cell dysplasia was found in 75 patients (24%) and in 53% (P0.01) of those positive for hepatitis B surface antigen (HBsAg). After a mean follow-up of 46 months, HCC was detected in 45 cases, and it was significantly more frequent in patients with liver cell dysplasia (P0.01) and HBsAg-serum positivity (P0.01). Multivariate analysis showed that liver cell dysplasia was the most important risk factor correlated with HCC development. HBsAg positivity and age over 60 years were also independent risk factors for HCC.These results indicate that liver cell dysplasia is a major risk factor for HCC, and it should be looked for carefully by pathologists in liver biopsy specimens to identify patients requiring more intensive observation.

The aim of our work was to assess the performance of tissue polypeptide antigen in detecting hepatocellular carcinoma in cirrhotic patients, while also checking for any influence of liver dysfunction on the serum level of the marker. One hundred and twenty-five consecutive cirrhotic patients, 35 with and 90 without, hepatocellular carcinoma were studied. Tissue polypeptide antigen had a different distribution in the two groups and the best diagnostic accuracy with 48.6% sensitivity and 85.6% specificity was found at the cut-off value of 240 UL-1. In cirrhotic patients significant linear correlations were found between tissue polypeptide antigen and alanine-transaminase, aspartate-transaminase, G-glutamyl-transpeptidase and alkaline phosphatase; there was no correlation with bilirubin or pseudo-cholinesterase. In patients with hepatocellular carcinoma a significant linear correlation was found only with alanine and aspartate transaminase and G-glutamyl-transpeptidase. The analysis of covariance still showed a significant difference between mean tissue polypeptide antigen levels in the two groups also accounting for covariates. These results suggest that: a) the liver dysfunction may be involved in increasing tissue polypeptide antigen values; b) tissue polypeptide antigen has a different distribution in cirrhotic patients with and without hepatocellular carcinoma also accounting for covariates; these findings further support the specificity of tissue polypeptide antigen.

Changes in respiratory frequencies with hypoxic or hyperoxic exposure were studied in: 12 normoxic control rats (N) born and raised in normoxic environment at sea level; 12 rats (A) born and raised in normoxic environment at sea level exposed to normobaric hypoxia (10% O2 in N2) as adults; 12 rats of first generation (G1) raised in the above mentioned hypoxic environment since a few hours after birth; 12 rats of third generation (G3) conceived and born in the hypoxic environment of hypoxic parents of second generation and maintained continuously under hypoxic conditions until their utilization. The response of A rats to 10% O2 and 7% O2 breathing was elevated (57% and 86% over air breathing). The mean respiratory frequency of A rats exposed to 7% O2 rose to a greater extent than did that of N rats. The G1 and G3 rats were less responsive to 7% O2 (64% and 37% over air breathing, respectively) than N and A rats; however, in G1 rats the exposure to 7% O2 produced a greater rise of frequency than in G3 rats. Furthermore A rats, G1 rats and G3 rats were less responsive to 97% O2 breathing (19%, 19% and 11% below air breathing, respectively). Comparing these data with previous findings we suggest that, with chronic exposure to hypoxia, changes in ventilatory response to hypoxia and hyperoxia occur in the following manner: I) loss of response to hypoxia if chronic exposure is begun in the immediate postnatal period; 2) degree of response to hypoxia or hyperoxia influenced by duration of chronic exposure.

Experience in liver transplantation (OLT) in Italy over a ten-year period is reported. Data were obtained using a multiple-items form collected from Italian liver transplant centres (reference centres) and other Italian institutions actively involved both in the processes of evaluation of the candidates and the follow-up of liver transplant recipients (afference centres). During this period, a total of 1046 liver transplants were performed on 954 patients, with a cumulative proportional survival of 71%. The most common indication for liver transplantation was post-hepatitic cirrhosis due to either hepatitis B virus (+/-hepatitis Delta virus) or hepatitis C virus infection. Good survival rates were observed, particularly in controversial indications, such as alcoholic cirrhosis, post-hepatitic hepatitis B virus-related cirrhosis and hepatocellular carcinoma, most likely due to proper and careful selection of the patients. Cirrhosis, secondary to an autoimmunity-based liver disease, showed the highest rate of rejection episodes. Infections, in our study population, were the most common cause of death after transplantation.