An open-label, non-comparative, non-interventional, multi-center, post-authorization safety study on the administration of rabeprazole to adults with gastro-esophageal reflux disease.

BACKGROUND: Rabeprazole produces a profound and long-lasting inhibition of gastric acid secretion. The aim of the study was to monitor the safety and efficacy of rabeprazole administered to patients with erosive or symptomatic non-erosive reflux disease, in real-life healthcare settings. METHODS: Male and female patients, aged ≥18 years, with endoscopy diagnosed GERD were included; patients received at least 8 weeks treatment with rabeprazole. Changes in severity of symptoms recorded on the Likert scale were analysed using marginal homogeneity tests. RESULTS: 186 patients were enrolled across 17 study sites; 127 patients (68.3%) completed the study. Almost 75% of patients had an initial diagnosis of GERD with Grade A or B esophagitis. The most commonly reported adverse events (AEs) were diarrhea, flatulence, dizziness, cough, abdominal pain, upper abdominal pain and somnolence. Over half of AEs were unrelated to study drug; 1 severe AE of diarrhea was possibly related to study drug. No new AEs were reported not included in the current version of Summary of Product Characteristics. Rabeprazole was effective in reducing the symptoms of GERD; the Likert scale scores of symptoms decreased significantly for all patients from 0-4 weeks and 4-8 weeks. CONCLUSIONS: In our study, rabeprazole was safe and effective in reducing the symptoms of GERD.

Frequency and predictors of no treatment in anti-hepatitis C virus-positive patients at tertiary liver centers in Greece.

BACKGROUND/AIMS: Despite the improving efficacy of antiviral therapy, a significant proportion of chronic hepatitis C patients never start treatment. We determined the magnitude and reasons for no treatment in anti-hepatitis C virus (HCV)-positive patients visiting tertiary liver centers in Greece. MATERIALS AND METHODS: We retrospectively enrolled 1146 consecutive anti-HCV-positive patients who visited four physicians at two tertiary liver centers between 2002 and 2010. RESULTS: Treatment was initiated in 628 (55%) of the 1146 patients. In particular, 309 (27%) patients were lost to follow-up before HCV RNA testing. Independent predictors of no HCV RNA testing were first visit before 2007, parenteral drug use, and the treating physician. Of the 837 patients tested for HCV RNA, 768 (92%) were eligible for antiviral therapy, had detectable serum HCV RNA, and no contraindication to treatment. Among them, 140 (18%) patients were lost to follow-up before the initiation of treatment or refused antiviral therapy. Independent predictors of no treatment were the treating physician, absence of liver biopsy or transient elastography (odds ratio: 3.5, 95% confidence interval: 2.3-5.4, P<0.001), and normal compared with elevated alanine transaminase levels (odds ratio: 1.7, 95% confidence interval: 1.1-2.8, P=0.027). CONCLUSION: A significant proportion (>40%) of anti-HCV-positive patients visiting Greek tertiary liver centers do not receive antiviral therapy. Most of them are lost during the initial evaluation process, whereas the majority (>80%) of eligible patients who complete the initial evaluation eventually start antiviral therapy. The probability of treatment seems to be significantly associated with the treating physician, the alanine transaminase levels, and whether liver biopsy or transient elastography was performed.

Long-term adefovir plus lamivudine therapy does not decrease creatinine clearance in HBeAg-negative chronic hepatitis B patients.

BACKGROUND/AIMS: As there are concerns about potential nephrotoxicity of nucleotide analogues, we evaluated renal function parameters during long-term adefovir and lamivudine combination therapy. METHODS: Forty-six HBeAg-negative patients with lamivudine-resistance treated with adefovir and lamivudine for up to 90 months were included. Renal function was assessed by estimated creatinine clearance (eC(CR) ) and compared with a matched control group of untreated inactive hepatitis B virus carriers. RESULTS: Serum HBV DNA became undetectable in 39 (85%) patients after a mean of 37 ± 21 months. Three (6.5%) patients developed virological breakthrough. Adefovir resistance was detected in two patients. At the end of follow up, there was a significant decrease in mean eC(CR) (95 ± 31-83 ± 30 ml/min, P = 0.003) in the treated patients with 16% presenting aeC(CR) decrease >30%. Similar changes in eC(CR) were observed in the control group (108 ± 28-96 ± 26 ml/min, P = 0.003). In multiple regression analysis, age and baseline eC(CR) were independent predictors of eC(CR) reduction. CONCLUSIONS: Adefovir and lamivudine combination therapy is not an independent factor for significant renal dysfunction in HBeAg-negative patients with lamivudine-resistance. Baseline age and creatinine clearance are the only independent predictors of worsening renal function.

Peginterferon/ribavirin treatment achieves a higher compliance rate than interferon/ribavirin combination in patients chronically infected with HCV on methadone maintenance.

INTRODUCTION: Chronic hepatitis C virus infection (HCV) is the most common infectious disease among intravenous drug users. AIMS: To determine and compare compliance rates between two groups of chronic HCV patients from the methadone substitution program of the National Greek Organization Against Drugs treated with either pegylated interferon alpha-2b/ribavirin or with interferon alpha-2b/ribavirin during 48 weeks of therapy and 24 weeks of follow-up. Furthermore, to evaluate the efficacy of each treatment modality. METHODS: Forty-five consecutive methadone maintenance (MM) patients (group A, 36 males, nine females) were treated with pegylated interferon alpha-2b (weight-based dosing 1.5 microg/kg/week) and ribavirin 1000-1200 mg/day orally. Sixty-five consecutive MM patients (group B, 52 males, 13 females) were treated with interferon alpha-2b (6 MIU, three times/week) and ribavirin with the doses reported above. During the study, all patients were followed up periodically by hepatologists, internists, and psychiatrists. RESULTS: Baseline characteristics were similar between the two groups. Thirty-four out of 45 patients (75.6%) from group A and 31 of 65 patients (47.7%) from group B completed therapy (P =0.006). Thirty-two (71.1%) patients from group A and 27 patients (41.5%) from group B were followed-up until the end of week 72 (P = 0.004). At the end of the follow-up, sustained virologic response was achieved in 23 of 45 (51.1%) patients from group A and 21 of 65 patients (32.3%) from group B (P =0.075). CONCLUSION: Pegylated interferon alpha-2b/ribavirin treatment achieved a significantly higher compliance rate than interferon alpha-2b/ribavirin in MM patients with chronic HCV infection. After 24 weeks of follow-up, response rates were similar for patients who were compliant to treatment for both groups.

Antiviral therapy reduces portal pressure in patients with cirrhosis due to HBeAg-negative chronic hepatitis B and significant portal hypertension.

BACKGROUND/AIMS: Lamivudine improves liver histology in patients with chronic hepatitis B (CHB), but its effects on portal pressure remain unknown. We evaluated the effect of lamivudine monotherapy on hepatic venous pressure gradient (HVPG) in CHB-related cirrhosis with significant portal hypertension. METHODS: We studied 19 patients with cirrhosis due to HBeAg-negative CHB and HVPG >or=10 mm Hg treated with oral lamivudine (100mg daily). Liver biochemistry, Child-Pugh and MELD score were determined every 3 months, alpha-fetoprotein and HBV DNA every 6 months and HVPG at baseline and at 12 months after lamivudine initiation. Diuretics, beta-blockers, antibiotics and/or endoscopic therapy were used for routine indications. RESULTS: At 12 months, a significant reduction was observed in ALT (p=0.001), HBV DNA (p=0.002), Child-Pugh (p=0.012) and MELD score (p=0.006). Four patients developed virological breakthrough during treatment. At 12 months, HVPG decreased in all but one patient [baseline: 14.4+/-3.9 and 12 months: 12.4+/-3.3 mm Hg (p=0.007)]. HVPG decreased >20% or below the 12 mm Hg threshold in 10 of 13 patients with baseline HVPG >or=12 mm Hg. HVPG increased in a patient with hepatic flare after virological breakthrough. CONCLUSION: In conclusion, in patients with cirrhosis due to HBeAg-negative CHB, lamivudine monotherapy reduces HVPG, especially when virological suppression and biochemical remission is achieved.

Is there a meaningful serum hepatitis B virus DNA cutoff level for therapeutic decisions in hepatitis B e antigen-negative chronic hepatitis B virus infection?

UNLABELLED: The diagnosis of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B indicating therapeutic intervention currently requires serum hepatitis B virus (HBV) DNA >or=2,000 IU/mL. We evaluated the severity of liver histology and the presence of histological indication for treatment in patients with HBeAg-negative chronic HBV infection focusing on those with low viremia and/or normal alanine aminotransferase (ALT). In total, 399 patients with increased ALT and detectable serum HBV DNA (chronic hepatitis B patients) and 35 cases with persistently normal ALT and HBV DNA >2,000 IU/mL (inactive carriers) were included. Histological indication for treatment (grading score >or=7 and/or stage >or=2 in Ishak's classification) was found in 91% (185/203), 82% (75/91), 75% (47/63), and 62% (26/42) of chronic hepatitis B patients with HBV DNA >or=200,000, 20,000-199,999, 2,000-19,999, and <2,000 IU/mL, respectively (P < 0.001). Histological indication for treatment was more frequent in chronic hepatitis B patients with persistently elevated ALT (86% or 275/321), but it was also found in 74% (58/78) of those with transiently normal ALT (P = 0.025). All inactive carriers had HBV DNA <20,000 IU/mL. Histological indication for treatment was present in 17% (6/35) of inactive carriers always due to moderate (stage 2) fibrosis without active necroinflammation. CONCLUSION: HBeAg-negative chronic HBV patients with persistently or transiently increased ALT and HBV DNA >or=20,000 IU/mL almost always require therapeutic intervention, but histological indications for treatment are also present in the majority of such cases with HBV DNA <20,000 and even <2,000 IU/mL. In contrast, minimal histological lesions are observed in the majority of HBeAg-negative patients with persistently normal ALT and HBV DNA >2,000 IU/mL, who may not require immediate liver biopsy and treatment but only close follow-up.

Does clinical response correlate with mucosal healing in patients with Crohn's disease of the small bowel? A prospective, case-series study using wireless capsule endoscopy.

BACKGROUND: There are no studies assessing mucosal healing of the small bowel in patients with Crohn's disease (CD). Our aim was to assess the correlation between clinical response and mucosal healing of the small bowel using wireless capsule endoscopy (WCE). METHODS: This was a prospective, multicenter, case-series study. Forty patients with known or suspected CD were included, recruited in 4 tertiary referral centers of Athens. They all had an acute flare-up of their disease (CD Activity Index [CDAI] >150), involvement of the small bowel, and the nonstricturing, nonpenetrating type of the disease. All patients underwent WCE prior to the initiation of any treatment. Treatment varied according to the treating physician. For the evaluation of mucosal healing, 3 endoscopic variables were collected: number of apthous ulcers, number of large ulcers, and period of time that any endoscopic lesion was visible (erythema, edema, ulcers). When patients achieved clinical response (after at least a month of treatment) they underwent a second WCE, with evaluation of the same parameters. RESULTS: The number of large ulcers was the only endoscopic variable that showed a significant improvement. The numbers of large ulcers before and after treatment were 8.3 +/- 1.4 and 5 +/- 0.8, respectively (mean +/- SEM) (mean difference 3.3 +/- 1.2, 95% confidence interval [CI] 0.8-5.9, P = 0.01). The other 2 variables did not improve significantly. CONCLUSIONS: Since only 1 out of 3 endoscopic variables improved significantly with treatment, we can conclude that clinical response does not seem to correlate with mucosal healing in patients with CD of the small bowel.

Fibrous ring formation in cirrhotics treated with band ligation.

BACKGROUND/AIMS: We observed that the formation of a fibrous ring following variceal eradication appeared to be associated with less variceal recurrence. We aimed to evaluate this formally. METHODOLOGY: Twenty-one cirrhotic patients with a fibrous ring formation in the esophagus after eradication of varices (FR group) were compared with 21 controls of similar age, gender and liver function but without ring formation after eradication in terms of variceal recurrence, portal hypertension related bleeding and survival. RESULTS: Both groups were similar with regard to baseline demographic and clinical data. During a mean follow-up period of 28.8+/-18.3 (SD) months, variceal recurrence occurred in 2 (9.5%) patients in the FR group compared to 10 (47.6%) in the control group (p=0.005). Cox regression model revealed a significant difference in probability of variceal recurrence between the two groups (p=0.006). In the FR group 1 patient bled and 3 died vs. 2 and 6 patients in the control group respectively. The differences between the groups in relation to bleeding and death were not statistically significant. CONCLUSIONS: In cirrhotic patients undergoing band ligation for eradication of esophageal varices, the formation of a fibrous ring is followed by a lower variceal recurrence rate.

Biliary tract malignancy and abnormal pancreaticobiliary junction in a Western population.

BACKGROUND AND AIM: Abnormal pancreaticobiliary junction is a rare congenital disorder in which the junction of biliary and pancreatic duct is located outside the duodenal wall and forms a long common channel. The disorder has been associated with a high incidence of gallbladder cancer in Japanese studies. The aim of this study was to assess the frequency of abnormal pancreaticobiliary junction in a Western population and its association with biliary tract malignancies. METHODS: All endoscopic retrograde cholangiopancreatography examinations of 82 consecutive patients with gallbladder carcinoma or biliary duct cancer treated at Baylor University during a period of 10 years were analyzed. A further 220 consecutive patients with normal films or non-malignant pancreaticobiliary disease acted as controls. RESULTS: Fifty-eight (70.7%) patients were found to have adequate imaging of junction and were included in the analysis. These included 37 patients with common bile duct carcinoma and 21 with gallbladder carcinoma. Abnormal pancreaticobiliary junction (common channel > or =8 mm) was observed in 44.8% patients with biliary tract carcinoma compared to 6.2% of controls (P < 0.01). Eighteen had type I abnormality and eight type II. Seven patients had a cystic dilatation of the common bile duct, all with type I abnormality. Mean overall survival was 9.5 months. Survival did not differ significantly between patients with normal and abnormal junctions (P = 0.1). CONCLUSIONS: The results suggest a close association between the anatomy of the distal ends of the common bile duct and main pancreatic duct and development of biliary tract carcinoma in Western populations.

An assessment of serum leptin levels in patients with chronic viral hepatitis: a prospective study.

BACKGROUND: The role of leptin in the course of liver disease due to chronic viral hepatitis (CVH) remains controversial. Our aims were to investigate the relationship between serum leptin concentrations and the severity of liver disease in a cohort of subjects with HBeAg negative chronic hepatitis B (CHB) and C (CHC) and to analyze the effect of body composition, the leptin system and insulin resistance together with viral factors on virologic response to antiviral treatment. METHODS: We studied 50 (36 men) consecutive patients suffering from biopsy-proven CVH due to HBV (n = 25) or HCV (n = 25) infection. Thirty-two (17 men) healthy volunteers served as controls. Levels of serum leptin and insulin were determined by immunoassays at baseline and at the end of the treatment. RESULTS: A significant association between serum leptin levels and the stage of hepatic fibrosis was noted; patients with cirrhosis presented higher serum leptin levels compared to those with lower fibrosis stage [CHB patients (17436 pg/ml vs 6028.5 pg/ml, p = 0.03), CHC patients (18014 pg/ml vs 4385 pg/ml, p = 0.05]. An inverse correlation between lower leptin levels and response to lamivudine monotherapy was noted in patients with CHB; those with a virologic response presented lower serum leptin levels (5334 vs 13111.5 pg/ml; p-value = 0.003) than non-responders. In genotype 1 CHC patients, insulin resistance played a significant role in the response to antiviral therapy. CONCLUSION: Our data clearly suggest that cirrhosis due to CHB or CHC is associated with higher leptin levels. Increased serum leptin levels represent a negative prognostic factor for response to lamivudine monotherapy in patients with CHB. In CHC patients insulin resistance strongly influences the response to antiviral treatment in patients infected with genotype 1.

Ultrasound-guided liver biopsy in real life: comparison of same-day prebiopsy versus real-time ultrasound approach.

BACKGROUND AND AIM: Currently, an increasing number of liver biopsies are performed by radiologists under real-time ultrasound control. A routine ultrasound assessment of a puncture site before performing percutaneous biopsy is reported to increase diagnostic yield and decrease complication rates. It is not clear if real-time ultrasound is superior to marking the puncture site before biopsy as regards reducing biopsy size and avoiding fragmentation and complications. The aim of this study was to compare ultrasound assessment of the puncture site before performing percutaneous liver biopsy with real-time ultrasound liver biopsy for suspected diffuse liver disease. METHODS: Consecutive percutaneous liver biopsies (n = 631) for diffuse liver disease were evaluated. Group A consisted of patients who had real-time guided-ultrasound biopsy performed by radiologists (241 patients; M/F, 35/106; median age 48 year [range, 17-76]; needle 18 G). Group B patients were assessed by radiologists using ultrasound of the puncture site on the same day that biopsies were performed by experienced gastroenterologists/hepatologists on the ward using the marked site (390 patients; M/F, 276/114; median age 43 year [range, 15-75]; needle 16 G). RESULTS: There were no differences in severity of liver disease, establishing a diagnosis (OR, 1.92 [95% CI, 0.84-4.34]; P = 0.12), length of liver biopsy specimens, number of fragments or complications. Two independent variables were significantly associated with a histological diagnosis: longer biopsy length (P < 0001) and fragment number of two or less (P < 0.001). CONCLUSION: Real-time ultrasound did not improve diagnostic yield or result in fewer complications. Marking the puncture site seems adequate and has the practical advantage that it takes up less of the radiologists' time.

A single alcohol ingestion does not affect serum hepatitis C virus RNA in patients with chronic hepatitis C.

BACKGROUND AND AIM: The safe level of alcohol ingestion in sporadic drinkers with hepatitis C is unknown. Our aim was to evaluate the effect of a single moderate alcohol intake on serum HCV RNA concentrations and hepatic function in patients with chronic HCV infection. METHODS: Twenty-one patients with chronic hepatitis C were randomly assigned to consume 50 g alcohol (group 1) or a non-alcoholic beverage (group 2). In both groups, serum ethanol, serum HCV RNA, transaminase and gamma-glutamyltranspeptidase (gamma-GT) levels were measured just before alcohol intake and after 1, 2, 8, 24 h and 1 week's time. RESULTS: The maximum concentration of ethanol in the blood was observed at the first hour after alcohol intake. No significant changes were observed in serum HCV RNA after alcohol intake. Repeated measurements of HCV RNA among the two groups revealed no difference (P = 0.215). Similarly, no difference was observed in transaminase and gamma-GT levels at different time points in each group or among the groups [(ALT (P = 0.082), AST (P = 0.33), gamma-GT (P = 0.538)]. CONCLUSIONS: In patients with chronic hepatitis C, a single intake of 50 g alcohol does not affect liver biochemistry and HCV RNA concentrations. Therefore, it is a matter of further research whether sporadic drinking of light or moderate amounts of alcohol should be avoided in patients with chronic hepatitis C.

Interferon-alpha plus lamivudine vs lamivudine reduces breakthroughs, but does not affect sustained response in HBeAg negative chronic hepatitis B.

AIM: The HBeAg negative form of chronic hepatitis B (CHB) predominates in the Mediterranean area and has a rising frequency in Europe and North America. At present there are three approved therapies for patients with CHB: interferon-alpha (IFN-alpha), lamivudine and adefovir dipivoxil. Unfortunately, none of these drugs are effective in achieving a sustained response in patients with HBeAg negative CHB. Therefore, new therapeutic approaches have been examined. Our aim was to investigate the efficacy of combination treatment of IFN-alpha and lamivudine compared to lamivudine monotherapy, after 24 mo of administration in HBeAg-negative hepatitis B patients. METHODS: Fifty consecutive patients were randomly assigned to receive IFN-alpha-2b (5 MU thrice per week, n = 24) plus lamivudine (100 mg daily) or lamivudine only (n = 26) for 24 mo. Patients were followed up for further 6 mo. The primary outcome was the proportion with sustained virological response (undetectable serum HBV DNA concentrations) and or sustained biochemical response (transaminase levels within normal range) at 30 mo (6 mo after the end of therapy). Secondary end-points were timed from initial virological (biochemical) response to VBR (BBR, respectively) and the emergence of YMDD mutants across the two arms. RESULTS: Five of twenty-four (21%) patients in the combination arm vs 3/26 (12%) in the lamivudine arm had sustained response (i.e., normal serum transaminase levels and undetectable HBV DNA by PCR assay) 6 mo after treatment discontinuation. A reduction in the emergence of YMDD mutants and in the development of virological breakthroughs was observed in patients receiving combination treatment (10% vs 46%, P = 0.01 and 14% vs 46%, P = 0.03, respectively). Time from initial virologic response to virologic breakthrough (VBR) was greater among initial responders receiving combination treatment compared to those receiving lamivudine (22.9 mo vs 15.9 mo, respectively; P = 0.005). CONCLUSION: Our results demonstrate that IFN-alpha plus lamivudine combination therapy did not increase the sustained response, compared to lamivudine. However, combination therapy reduces the likelihood of VBR due to YMDD mutants and prolongs the time period until the breakthrough development.

Outcome of hepatitis B e antigen-negative chronic hepatitis B on long-term nucleos(t)ide analog therapy starting with lamivudine.

We determined the clinical outcome of hepatitis e antigen (HBeAg)-negative chronic hepatitis B patients treated with long-term nucleos(t)ide analog therapy starting with lamivudine. We evaluated 201 such patients treated for 3.8 +/- 1.4 years and 2 historical similar cohorts: 1 treated with interferon-alfa (n = 209) and 1 untreated (n = 195). Virological or biochemical remission rate at 48 months under lamivudine was 34% or 36%, respectively, whereas adefovir was administered in 79 patients with virological-biochemical breakthroughs or no response. Of the lamivudine-treated patients, 4 died, 1 underwent a transplantation, and another 8 developed major events, all having advanced fibrosis at baseline and all but 1 having experienced breakthroughs or no response. At 5 years, survival was 96%, and major event-free survival was 93%. The major event-free survival was significantly better in patients with than in those without virological remission under lamivudine. At the end of follow-up, both survival and major event-free survival were independently associated with type of and response to treatment, being significantly better in patients under long-term antiviral therapy or interferon sustained responders than in interferon non-sustained responders or untreated cases (5-year survival: 96% or 98% vs. 88% or 90%, respectively). In conclusion, in HBeAg-negative chronic hepatitis B, long-term nucleos(t)ide analog therapy starting with lamivudine significantly improves survival and reduces the risk of major complications, compared with interferon non-sustained responders or untreated patients. In such patients with advanced fibrosis, close follow-up for lamivudine resistance and prompt onset of additional antiviral therapy is required or the ab initio use of agent(s) with low resistance rates should be considered.

Clinical course of lamivudine monotherapy in patients with decompensated cirrhosis due to HBeAg negative chronic HBV infection.

OBJECTIVES: We have evaluated the efficacy of long-term lamivudine monotherapy in patients with decompensated HBeAg-negative/HBV-DNA positive cirrhosis. METHODS: We analyzed the clinical course and outcome of lamivudine treatment in 30 consecutive cirrhotics and compared with 30 HBV untreated historical HBeAg-negative controls matched for age and gender. RESULTS: Significant clinical improvement, defined as a reduction of at least two points in Child-Pugh score was observed in 23 of the 30 treated patients (76.6%) versus none of the 30 patients in the control group (p < 0.0001) after a mean follow-up of 20.6 +/- 12.1(+/-SD) months. There were 10 deaths in the treated group versus 24 in the control group (p= 0.07). Liver-related deaths occurred in five of the eight patients soon after the development of biochemical breakthrough. Patients with clinical improvement had better survival than patients with no improvement (p= 0.04) or those who developed biochemical breakthrough due to YMDD mutants (p= 0.001). CONCLUSIONS: Lamivudine significantly improves liver function in HBeAg-negative decompensated cirrhosis. However, the development of the biochemical breakthrough due to YMDD mutants is associated with fatal outcome.

Increased fasting serum levels of growth hormone and gastrin in patients with gastric and large bowel cancer.

BACKGROUND: Growth hormone (GH), Insulin-like growth factor-I (somatomedine, IGF-I) and gastrin seem to play a significant role in cell proliferation in mammalian and rat cells. The role of these factors in the etiology of gastric and large bowel cancer has not been completely elucidated. The aim of this study was to concurrently estimate the levels of GH, IGF-I and gastrin in a group of patients with gastric and colorectal cancer and to compare the results with those of a group of normal controls. PATIENTS AND METHODS: In 33 consecutive patients with gastric (16 patients) and large bowel (17 patients) cancer, the serum levels of GH, IGF-I and gastrin were measured by radioimmunoassay. Fifty-four normal people were served as controls. RESULTS: Significantly higher levels of serum GH (3.16 +/- 3.12 ng/ml in gastric cancer patients vs. 3.01 +/- 2.91 ng/ml in colorectal cancer patients vs. 0.69 +/- 1.60 ng/ml in normal controls, adjusted P<0.001) and gastrin (98.2 +/- 87.9 pg/ml in gastric cancer patients vs. 95.3 +/- 85.4 pg/ml in colorectal cancer patients, vs. 47.5 +/- 32.4 pg/ml in normal controls, adjusted P<0.035 and <0.05 respectively) were found in both groups of patients compared with normal controls. The levels of IGF-I in patients with gastric and colorectal cancer although higher compared to normal controls did not reach statistical significance. (98.2 +/- 87.9 pg/ml vs. 95.3 +/- 85.4 vs. 47.5 +/- 32.4 respectively) (adjusted P=0.070). CONCLUSION: It is concluded that in patients with gastric and colorectal cancer a significant increase of serum GH and gastrin can be found. This increase is likely to play a role in gastric and colorectal carcinogenesis.

Serum gastrin levels in patients with inflammatory bowel disease.

The aim of this study was to estimate the levels of serum gastrin in a group of patients with either ulcerative colitis or Crohn's disease and to compare the results with those of a group of normal controls. In 108 consecutive patients with IBD (66 with ulcerative colitis, 32 with Crohn's disease and 10 with indetermined colitis) serum levels of gastrin were measured by radioimmunoassay. One hundred and eight normal people were served as controls. The levels of serum gastrin were significantly elevated in patients with Crohn's disease compared to normal controls (74.4 +/- 43.9 pg/ml vs. 47.5 +/- 32.4 pg/ml, P<0.05), irrespectively of the activity of the disease. On the contrary, patients with ulcerative colitis exhibited no significant differences compared to normal controls. Differences between Crohn's disease and ulcerative colitis patients were statistically significant (P<0.001). The rate of infection by Helicobacter pylori in patients with inflammatory bowel disease was statistically significantly lower as compared with normal controls (31.7% vs. 55.1%, P<0.001). It is concluded that patients with active or inactive Crohn's disease have increased levels of serum gastrin. This may have implications concerning the high incidence of upper GI lesions found in patients with Crohn's disease despite the very low incidence of Helicobacter pylori infection.

Octreotide versus hydrocortisone versus placebo in the prevention of post-ERCP pancreatitis: a multicenter randomized controlled trial.

BACKGROUND: Octreotide is a potent inhibitor of pancreatic secretion, and corticosteroids suppress humoral and cellular activity. Both agents may reduce the frequency of post-ERCP pancreatitis. The aim of this study was to determine the effectiveness of octreotide and hydrocortisone in preventing post-ERCP pancreatitis. METHODS: Three hundred fifty-four patients were entered in to a multicenter randomized controlled trial of 100 microg subcutaneous octreotide (Group 1) versus 100 mg intravenous hydrocortisone (Group 2) versus normal saline solution as placebo (Group 3). All medications were administered approximately 30 minutes before the procedure. Patients were assessed clinically and serum amylase was also measured before the procedure and 3, 12, and 24 hours after the procedure. RESULTS: Three hundred forty patients were included in the analysis. Pancreatitis was observed in 11 of 112 patients (9.8%) in Group 1, 8 of 113 (7.1%) patients in Group 2, and in 15 of 115 (13.0%) patients in Group 3 (p = 0.32). The mean length of hospitalization in days was similar in all 3 groups: mean (SD) for Groups 1, 2, and 3 were, respectively, 3.6 (1.6) versus 2.9 (0.6) versus 4.3 (1.8) (p = 0.13). Multivariate logistic regression analysis showed that number of pancreatic injections, suspicion of sphincter dysfunction, therapeutic procedure, and age were risk factors for pancreatitis. CONCLUSIONS: The results of this trial indicate that octreotide and hydrocortisone do not prevent ERCP-induced pancreatitis.