BACKGROUND: Rapid urease tests for Helicobacter pylori have a sensitivity of 80% to 90%. Therefore histologic examination of gastric biopsies is recommended as a "backup" diagnostic test in rapid urease test-negative patients. However, noninvasive tests (urea breath test, serology, whole blood antibody tests) may provide a more rapid diagnosis and be less expensive but offer similar accuracy. METHODS: Sixty-seven patients (no prior treatment for H pylori, no proton pump inhibitors, antibiotics, or bismuth within 4 weeks) undergoing endoscopy for evaluation of dyspepsia symptoms and testing rapid urease test-negative by antral biopsy were enrolled. All had the following tests: gastric biopsies (2 antral, 1 fundus; H&E and Alcian Yellow stain) examined for gastritis and H pylori; (13)C-UBT; capillary blood for whole blood rapid antibody tests: FlexSure HP, QuickVue, AccuStat, and Stat-Simple Pylori; serum for FlexSure HP; HM-CAP enzyme-linked immunoassay. H pylori infection was diagnosed (reference standard) if chronic gastritis was present on histology and at least 2 of the 3 following tests were positive: urea breath test, H pylori organisms unequivocally demonstrated in biopsies on special stain, and/or enzyme-linked immunoassay. The test and treatment costs per patient were calculated. RESULTS: Of 67 patients with a negative rapid urease test, 4 were positive for H pylori. None had active peptic ulcer disease. Histology only identified 1 patient with organisms visible on special stain. Using chronic active gastritis (neutrophilic and mononuclear infiltrate) as a diagnostic criterion for H pylori, 6 patients would have been judged positive. However, only 2 of these were truly positive by the reference standard (positive predictive value 33%). Negative predictive value for presence of organisms and chronic active gastritis was 95% and 97%, respectively. All of the noninvasive tests identified all 4 truly positive patients correctly. Urea breath test and FlexSure whole blood assay yielded a substantial number of false-positive results (positive predictive value 31% and 36%, respectively); positive predictive value for the other tests ranged from 50% to 80%. All tests except histology had a negative predictive value of 100%. Histology was the most costly test (p < 0. 001 compared with all other tests), followed by urea breath test and HM-CAP serology (p < 0.001 compared with all rapid antibody tests). CONCLUSIONS: Whole blood or serum antibody testing is a rapid, accurate, and cost-effective means for establishing H pylori status in rapid urease test-negative patients. Whole blood or serology rapid antibody testing should substitute for histology when the patient has not been previously treated for H pylori.

Adult↗

PubMed2000

EUS in cirrhotic patients with and without prior variceal hemorrhage in comparison with noncirrhotic control subjects.

BACKGROUND: Endoscopic ultrasound (EUS) was used to evaluate cirrhotic patients with and without prior variceal hemorrhage. The findings were compared with those of EUS in noncirrhotic control subjects to determine EUS features indicative of cirrhosis and of a risk for variceal hemorrhage. METHODS: Patients with cirrhosis undergoing indicated endoscopic screening for varices or surveillance after endoscopic therapy for variceal hemorrhage were studied and compared with healthy noncirrhotic control patients undergoing EUS for benign conditions. RESULTS: Sixty-six cirrhotic patients (31 with prior hemorrhage) and 32 control patients were studied. Nonhemorrhage cirrhotic patients had more severe liver disease by Child's class (p = 0.02) and less beta-adrenergic blocker usage (p < 0.0001). Paraesophageal varices were detected in 97% of cirrhotic patients and 3% of control patients (p < 0.001) and were a more sensitive predictor of cirrhosis than varices at endoscopy (74%, p < 0.0001). Azygos vein and thoracic duct diameters, and gastric mucosa and submucosa thickness were greater for cirrhotic than control patients (p < 0.001). More hemorrhage patients had large (5 mm or greater) paraesophageal varices (odds ratio 3.1: 95% CI [1.1, 8.3]; p < 0.05) and paragastric varices (odds ratio 3.7: 95% CI [1.3, 10.2]; p = 0.01). Paraesophageal varix size correlated with ascites (p = 0.03) and, for nonhemorrhage patients, with Child's class (p < 0.01). CONCLUSIONS: Paraesophageal and paragastric varices correlate with the presence and severity of liver disease and portal hypertension. These data support the hypothesis that large paraesophageal and paragastric varices (5 mm or greater) may be risk factors for variceal hemorrhage, an observation that merits further prospective study. Cirrhosis causes dilation of the azygos vein and thoracic duct and thickening of gastric mucosa and submucosa.

Azygos Vein↗

PubMed2000

Evaluation of rapid antibody tests for the diagnosis of Helicobacter pylori infection.

OBJECTIVE: The aim of this study was to compare the performance characteristics of one serum and four whole blood rapid antibody tests for Helicobacter pylori infection. METHODS: A total of 97 outpatients referred for endoscopic evaluation of dyspepsia were included. Antral biopsies were obtained for histology and rapid urease test. Serum was tested with an enzyme-linked immunoassay (HM-CAP) and a rapid serology test (FlexSure HP). A commercially available 13C-urea breath test was performed. Capillary blood obtained by fingerstick was tested with FlexSure HP, QuickVue, Accustat, and StatSimple pylori tests. Sensitivity, specificity, and accuracy of each rapid test was calculated relative to a criterion standard of histological gastritis and at least two of the four following tests positive: identifiable organisms on specially stained slides, rapid urease test, urea breath test, or serum immunoassay. RESULTS: A total of 30 patients (31%) were infected. The FlexSure HP Serum, and FlexSure HP, QuickVue, Accustat, and StatSimple pylori whole blood tests had sensitivities of 90%, 87%, 83%, 76%, and 90%; specificities of 94%, 90%, 96%, 96%, and 98%, and accuracies of 93%, 88%, 92%, 87%, and 96%, respectively. Sensitivities were not statistically different. StatSimple pylori was more specific than FlexSure HP whole blood (p<0.03), and more accurate than FlexSure whole blood (p<0.024) and Accustat (p< 0.01). Serum immunoassay was significantly more sensitive (97%) than FlexSure whole blood, QuickVue, and Accustat (p<0.01), but its specificity (95%) was not statistically different from the rapid tests. CONCLUSION: Rapid antibody testing provides an accurate diagnosis of H. pylori infection. In general, these tests are less sensitive than, but as specific as, standard serology.

Adult↗

PubMed2000

Esophageal dilation for endosonographic evaluation of malignant esophageal strictures is safe and effective.

OBJECTIVE: Endoscopic ultrasound (EUS) is accepted as the most accurate modality for T- and N-staging of esophageal cancer, but some malignant strictures prevent passage of the echoendoscope beyond the level of the tumor. This incomplete evaluation may decrease staging accuracy. Previous studies have yielded conflicting results regarding the safety and efficacy of esophageal dilation for EUS. METHODS: We prospectively evaluated 267 consecutive patients undergoing EUS for esophageal carcinoma staging at our institution over a 66-month period to determine the number of patients requiring dilation for EUS examination, the success of dilation, safety of dilation, and clinical importance. RESULTS: Among 267 endosonographic examinations of the esophagus, 81 (30.3%) required dilation to advance the echoendoscope beyond the level of the stricture. After dilation was performed, the echoendoscope could be passed through the stricture in 69 patients (85.2%), and in 63 of 67 of the patients dilated to > or = 14 mm (94.0%). No complications have occurred secondary to the dilations performed to permit completion of the endosonographic examination. Tumor staging by EUS after dilation was T2 (14.8%), T3 (56.8%), and T4 (21.0%), nodal staging N0 (14.6%) and N1 (75.3%); and M1 (9.9%). CONCLUSIONS: We conclude that incremental, stepwise dilation of malignant strictures to 14 mm is safe and effective in permitting echoendoscope passage beyond the stenosis. The presence of a malignant stricture does not seem to diminish the utility of EUS staging of esophageal cancer.

Catheterization↗

PubMed1999

Effectiveness of Helicobacter pylori therapies in a clinical practice setting.

BACKGROUND: Whether eradication rates for Helicobacter pylori treatment regimens obtained in controlled clinical trials (efficacy) can also be obtained in clinical practice (effectiveness) is unknown because no such trials have been reported in the United States. OBJECTIVES: To determine the eradication rates of H pylori in a community practice setting and the effects of practice variation in the choice of treatment regimen on patient outcome (H pylori infection cure) and cost. METHODS: Between February 1 and December 30, 1996, 38 community-based gastroenterologists in the Portland, Ore, metropolitan area enrolled a total of 250 patients infected with H pylori, as determined by endoscopic or noninvasive methods. Various therapeutic regimens aimed at eradicating H pylori were used by the gastroenterologists, and a posttreatment urea breath test was used to determine H pylori infection cure. Compliance and incidental effects were also measured and decision analysis was used to estimate the cost of treatment. RESULTS: The regimens used varied considerably. Patients receiving a 2- or 3-times-a-day treatment regimen were significantly more compliant (P=.01) than those receiving a 4-times-a-day regimen. Proton pump inhibitor-based triple-therapy regimens were significantly more effective than all other treatment regimens combined (87% vs 70%; P = .001) in eradicating H pylori. These proton pump inhibitor-based triple-therapy regimens were also more cost-effective by decision analysis for a hypothetical cohort of patients with duodenal ulcer disease. CONCLUSIONS: The considerable variation in the choice of treatment regimens affects the clinical and economic outcomes of patients undergoing therapy for H pylori infection. Whether these data reflect the outcome in other communities is unknown but should be determined. It will be necessary to determine if the dissemination of these data results in a reduction of practice variation and improvement in clinical and economic outcomes of patients being treated for H pylori infection in clinical practice.

Anti-Bacterial Agents↗

PubMed1999