Sergio Sartori

Evaluation of a new enzyme immunoassay for detecting Helicobacter pylori in feces : a prospective pilot study

OBJECTIVES:There is an increasing interest in noninvasive tests for detecting Helicobacter pylori (H. pylori) infection. Unlike serological and urea breath tests, the possibility of searching for H. pylori in feces has been scarcely investigated. The aim of this prospective pilot study was to evaluate the usefulness of a new enzyme immunoassay for detecting H. pylori antigens in feces, as a predictor of H. pylori status in the pre- and posttreatment settings.METHODS:One hundred and fifty-four symptomatic, anti-H. pylori untreated patients (Group A) and 116 anti-H. pylori treated patients (Group B) underwent gastroscopy with biopsies of the antrum and corpus for histology (H) and rapid urease test (RUT). In the anti-H. pylori treated group, a 13C-urea breath test (UBT) was also performed. In Group A, H. pylori status was defined as positive or negative when both H and RUT gave concordant positive or negative results. In Group B, the patients were considered eradicated if all three tests were negative. A stool specimen was collected from all patients the day after gastroscopy, and tested by using an enzyme immunoassay commercial kit for detecting H. pylori antigens in feces (HpSAT).RESULTS:Eighty-five patients in Group A (55%) and 44 in Group B (38%) were H. pylori infected. On the whole, HpSAT showed a sensitivity of 94% and specificity of 86%. In Group A and Group B, sensitivity and specificity were 94%versus 93%, and 90%versus 82%, respectively (p < 0.05).CONCLUSIONS:HpSAT seems to be a reliable method for predicting H. pylori status in anti-H. pylori untreated patients. Conversely, the test appears less suitable to evaluate the outcome of the eradicating treatment. Consequently, it is likely to be accepted for the primary diagnosis of H. pylori status, particularly in dyspeptic young patients.

Accuracy of transthoracic sonography in detection of pneumothorax after sonographically guided lung biopsy: prospective comparison with chest radiography.

OBJECTIVE The purpose of this study was to prospectively evaluate the accuracy of transthoracic sonography in the detection of pneumothorax after transthoracic sonographically guided lung biopsy. SUBJECTS AND METHODS Transthoracic sonography was performed on 285 patients after transthoracic sonographically guided lung biopsy. Disappearance of the sliding lung and comettail artifacts and appearance of reverberation artifacts were considered evidence of pneumothorax. Upright chest radiography was performed within 30 minutes of transthoracic sonography. If a discrepancy between transthoracic sonographic and chest radiographic findings occurred, CT was performed. When it was diagnosed, pneumothorax was sonographically monitored. After visualization of resolution of pneumothorax, chest radiography was performed to confirm the resolution. RESULTS Pneumothorax occurred in eight (2.8%) of the patients. Transthoracic sonography depicted all cases of pneumothorax and excluded pneumothorax in the other cases. Chest radiography did not depict one case of pneumothorax, which was confirmed on CT. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were all 100% for transthoracic sonography and 87.5%, 100%, 100%, 99.6%, and 99.6%, respectively, for chest radiography. The 95% confidence intervals (CI) of the differences in sensitivity, negative predictive value, and overall accuracy were -10% to 35%, -0.1 to 0.9%, and -0.1 to 0.9%. Transthoracic sonographic visualization of resolution of pneumothorax was always confirmed with chest radiography. CONCLUSION These preliminary results suggest that transthoracic sonography is as effective as chest radiography in the detection of pneumothorax after transthoracic sonographically guided lung biopsy and may become the method of choice for excluding, diagnosing, and monitoring pneumothorax after transthoracic sonographically guided biopsy. Chest radiography may be needed only for assessment of the extent of pulmonary collapse after transthoracic sonographic diagnosis of pneumothorax or in the presence of discrepancy between transthoracic sonographic findings and clinical presentation.

Prospective Randomized Trial of Intrapleural Bleomycin Versus Interferon Alfa-2b via Ultrasound-Guided Small-Bore Chest Tube in the Palliative Treatment of Malignant Pleural Effusions

PURPOSE To compare bleomycin pleurodesis and immunotherapy with intrapleural interferon alfa-2b (IFN) in the palliation of malignant pleural effusions. PATIENTS AND METHODS One hundred sixty patients with rapidly recurrent malignant pleural effusion were randomly assigned to intrapleural bleomycin (83 patients) or IFN (77 patients). A 9-French intrapleural catheter was placed under sonographic guidance, and pleural effusion was completely drained before starting the treatment. Bleomycin 0.75 mg/kg was administered as a single dose. An additional dose was given if daily fluid output did not drop to less than 100 mL/d within 3 days. IFN 1 million units/10 kg was administered for six courses at 4-day intervals. Thirty-day and long-term responses were evaluated under the intention-to-treat principle. RESULTS Thirty-day response was 84.3% in the bleomycin arm and 62.3% in IFN arm (P =.002). Median time to progression was 93 days (range, 12 to 395 days) in bleomycin group, and 59 days (range, 7 to 292 days) in the IFN group (P <.001). Median survival was 96 days (range, 15 to 395) and 85 days (range, 16 to 292) in the bleomycin and IFN groups, respectively. Twenty-three patients received two doses of bleomycin, as their daily fluid output remained higher than 100 mL after the first dose. Thirteen of them had complete response, which lasted until death. CONCLUSION Intrapleural bleomycin is more effective than IFN and is a valid option for the palliative treatment of massive, rapidly recurrent malignant pleural effusions. The administration of a second dose of bleomycin to patients not responding to the first one can remarkably improve the overall outcome of the treatment.

Barrett Esophagus after Chemotherapy with Cyclophosphamide, Methotrexate, and 5-Fluorouracil (CMF): An Iatrogenic Injury?

In Barrett esophagus, the squamous mucosa of the lower esophagus is replaced by columnar epithelium (1). This metaplastic disorder can result from a congenital abnormality, but more frequently resu...

Subcapsular Liver Tumors Treated with Percutaneous Radiofrequency Ablation: A Prospective Comparison with Nonsubcapsular Liver Tumors for Safety and Effectiveness

PURPOSE To assess the safety and effectiveness of percutaneous radiofrequency (RF) ablation of subcapsular liver tumors. MATERIALS AND METHODS The study protocol was approved by the institutional review board, and all patients gave written informed consent. One hundred eighty-one patients (79 men, 102 women; age range, 36-85 years) underwent ultrasonographically (US) guided percutaneous RF ablation of 361 primary or secondary (metastatic) liver tumors. Forty-four patients had one or more subcapsular nodules (group 1), and 137 had nonsubcapsular nodules only (group 2). Overall, 80 nodules were subcapsular and 281 were nonsubcapsular. The completeness of the ablation was assessed with contrast material-enhanced computed tomography (CT) 1 month after RF ablation. If residual tumor was documented, RF ablation was repeated. All patients in whom the ablation was complete after the first or second ablation session were monitored with CT or contrast-enhanced US every 3 months. Major complication, complete ablation, and local tumor progression rates were compared by using the chi(2) test or Fisher exact test. RESULTS Three (7%) major complications (intraperitoneal bleeding, skin burn, and tumor seeding) occurred in group 1, and two (1.5%) cases of tumor seeding occurred in group 2 (P = .093). No RF ablation-related deaths occurred. The complete ablation rate was 98% (43 of 44 patients) in group 1 and 98.5% (135 of 137 patients) in group 2 (P = .756). The local tumor progression rate after a median follow-up of 25 months (range, 13-54 months) was 16% (seven of 43 patients) in group 1 and 9.6% (13 of 135 patients) in group 2 (P = .355). CONCLUSION The difference in major complication rate between the subcapsular and nonsubcapsular liver tumors was not significant. The safety of RF ablation of subcapsular tumors seems acceptable, and the effectiveness is comparable to that of RF ablation of nonsubcapsular tumors.

Randomized Trial of Omeprazole or Ranitidine Versus Placebo in the Prevention of Chemotherapy-Induced Gastroduodenal Injury

PURPOSE Anticancer drugs may induce acute mucosal injury to stomach and duodenum. This study was planned to evaluate the efficacy of omeprazole or ranitidine in preventing such an injury. PATIENTS AND METHODS Two hundred twenty-eight cancer patients with normal stomach and duodenum or with less than three erosions, who were selected to be treated with cyclophosphamide, methotrexate, and fluorouracil (90 breast carcinoma patients) or fluorouracil alone (138 colon carcinoma patients), were randomly assigned to treatment with omeprazole 20 mg, ranitidine 300 mg, or one placebo tablet a day. Seven days after the second course of chemotherapy (CT), the patients underwent a further esophagogastroduodenoscopy to evaluate the mucosal injury. Endoscopic findings were quantified on the basis of an arbitrary score, and the occurrence of epigastric pain or heartburn was assessed weekly. RESULTS A significant difference was found among the three groups (P =.0032), as well as between pre- and postCT endoscopic findings (P =.00001). Endoscopic scores after CT were significantly higher than pretreatment scores in the placebo (P =.003) and ranitidine (P =.003) groups but not in the omeprazole group (P =.354). Acute ulcers were significantly less frequent in patients receiving omeprazole or ranitidine than in those receiving placebo (P =.0001 and P =.0315, respectively). Epigastric pain and/or heartburn were significantly less frequent in patients receiving omeprazole (P =.00124) or ranitidine (P =.038) than in those receiving placebo. CONCLUSION Omeprazole is effective in preventing chemotherapy-induced gastroduodenal injury. Ranitidine is effective in reducing the frequency of ulcers and upper gastrointestinal symptoms but is not effective in preventing the global endoscopic worsening caused by chemotherapy. The different efficacy of omeprazole and ranitidine can be explained by their different pharmacodynamics.

Helicobacter pylori and chronic bronchitis.

BACKGROUND Chronic infections such as those caused by Helicobacter pylori, Chlamydia pneumoniae, and cytomegalovirus have been epidemiologically related to coronary heart disease (CHD). Other studies place H. pylori in relation to other extradigestive diseases. We carried out an epidemiologic pilot study to evaluate the prevalence of H. pylori in patients with chronic bronchitis, a respiratory disease characterized by persistent chronic inflammation, in comparison with a matched control group. METHODS An enzyme-linked immunosorbent assay IgG test for H. pylori diagnosis was performed in 60 consecutive patients with chronic bronchitis (15 women and 45 men; age range, 50-89 years; mean age, 70.38 years) and in 69 control subjects, well matched for age and social status (19 women and 50 men: age range, 52-90 years; mean age, 71.3 years). RESULTS Foty-nine of 60 patients with chronic bronchitis (81.6%) and 40 of 69 subjects in the control group (57.9%) were H. pylori-positive (P = 0.0079). The odds ratio, calculated by simple analysis (3.2) and confirmed by logistic regression analysis (3.399), indicated that H. pylori infection greatly increases the risk of chronic bronchitis. CONCLUSIONS To date, CHD is the only convincing association between H. pylori infection and an extradigestive disease. The main conclusion of this pilot study is that H. pylori infection seems to increase the risk of developing of chronic bronchitis. An important step in this field will be to evaluate the possible change in the clinical conditions after successful eradication therapy in H. pylori-positive patients with chronic bronchitis.

Short-term low-dose triple therapy with azithromycin, metronidazole and lansoprazole appears highly effective for the eradication of Helicobacter pylori

Background: Although the OCN (omeprazole, clarithromycin and nitroimidazoles) shortterm low‐dose regimens are regarded as ‘the standard’ in the treatment of Helicobacter pylori infection, azithromycin is a new‐generation, acid‐stable macrolide which may prove particularly useful for a new short‐term low‐dose triple therapy regimen. Objective: To further improve OCN eradication treatments by reducing both the number of pills and the total cost. Methods: A new short‐term low‐dose triple therapy (LAM) using lansoprazole 30mg once a day for 1 week, azithromycin 500 mg once a day for 3 days, and metronidazole 250mg twice a day for the same 3 days, was administrated to 60 patients presenting with H. pylori‐positive gastritis with or without peptic ulcer, and compared with the classic ‘Bazzoli regimen’ (OCT: omeprazole, clarithromycin, tinidazole) in 60 matched patients. H. pylori infection before and after therapy was evaluated by a rapid urease test, conventional histology and toluidine‐stained semi‐thin sections. Three biopsies from the corpus and three from the antrum were taken during endoscopical examination before and 7‐8 weeks after discontinuation of the treatment. Patient compliance, drug tolerance and drug costs were also taken into consideration. Results: H. pylori infection was eradicated 7‐8 weeks after treatment in 56 of the 60 patients in the LAM group (93.3%), and in 52 of the 57 patients in the OCT group who completed the treatment (91.2%), with no statistical difference. When gastric or duodenal ulceration was present, ulcer healing was observed in all cases. Conclusion: The new proposed short‐term low‐dose triple therapy (LAM) appears to be as effective as the OCT for the eradication of H. pylori infection. The new treatment, however, seems to have advantages in terms of drug tolerance, patient compliance and therapy cost.

Helicobacter pylori stool antigen test: clinical evaluation and cost analysis of a new enzyme immunoassay.

Noninvasive tests for Helicobacter pylori areincreasingly used. Recently, an enzyme immunoassay forH. pylori detection in feces has been put on the market.Aim of this multicenter study was to evaluate the usefulness of this novel test as apredictor of H. pylori status in the pretreatmentsetting. Three hundred consecutive patients wereenrolled. None of the patients had received anyeradicating treatment in the last 12 months, and all underwentgastroscopy with biopsies of the antrum and body forhistology (H) and rapid urease test (RUT). H. pyloristatus was defined positive (or negative) if both H and RUT were positive (or negative). When H and RUTgave conflicting results, the patients were classifiedas H. pylori indeterminate. A stool specimen wascollected for each patient and tested by using a novel enzyme immunoassay for H. pylori detection(HpSAT). Sensitivity, specificity, and diagnosticaccuracy of the test were calculated, as was the cost ofeach assay. H. pylori status was positive in 159patients, negative in 131, and indeterminate in 10. HpSATgave evaluable results (positive or negative) in 293patients, and doubtful results in 7 (2.3%). Sensitivity,specificity, and diagnostic accuracy of HpSAT were 96.8%, 89.7%, and 93.6% respectively.Considering the H. pylori-indeterminate patients aspositive, the percentages were 95.8%, 98.7%, and 93.2%respectively. The cost for each assay was about US

Evaluation of a Standardized Protocol of Intracavitary Recombinant Interferon Alpha-2b in the Palliative Treatment of Malignant Peritoneal Effusions

27. These results suggest that HpSAT is anoninvasive, simple, reliable, fast, and cheap methodfor evaluating H. pylori status in the pretreatmentsetting.