Diagnostic accuracy of the Oakland score versus haemoglobin for predicting outcomes in lower gastrointestinal bleeding.

BACKGROUND: Acute lower gastrointestinal bleeding (ALGIB) is a common cause of hospitalization. Recent guidelines recommend the use of prognostic scales for risk stratification. However, it remains unclear whether risk scores are more accurate than some simpler prognostic variables. OBJECTIVE: To compare the predictive values of haemoglobin alone and the Oakland score for predicting outcomes in ALGIB patients. DESIGN: Single-centre, retrospective study at a University Hospital. Data were extracted from the hospital's clinical records. The Oakland score was calculated at admission. Study outcomes were defined according to the original article describing the Oakland score: safe discharge (the primary Oakland score outcome), transfusion, rebleeding, readmission, therapeutic intervention and death. Area under the receiver operating characteristics (AUROC) curve and accuracy using haemoglobin and the Oakland score were calculated for each outcome. RESULTS: Two hundred and fifty-eight patients were included. Eighty-four (32.6%) needed transfusion, 50 (19.4%) presented rebleeding, 31 (12.1%) required therapeutic intervention, 20 (7.8%) were readmitted and six (2.3%) died. There were no differences in the AUROC curve values for haemoglobin versus the Oakland score with regard to safe discharge (0.82 (0.77-0.88) vs 0.80 (0.74-0.86), respectively) or to therapeutic intervention and death. Haemoglobin was significantly better for predicting transfusion and rebleeding, and the Oakland score was significantly better for predicting readmission. CONCLUSION: In our study, the Oakland score did not perform better than haemoglobin alone for predicting the outcome of patients with ALGIB. The usefulness of risk scores for predicting outcomes in clinical practice remains uncertain.

Comparable quality of bowel preparation with single-day versus three-day low-residue diet: Randomized controlled trial.

BACKGROUND AND AIMS: There is controversy about the length of low-residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one-day vs. three-day LRD associated to standard laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy. METHODS: A non-inferiority, randomized, controlled, parallel-group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomized to receive 1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥ 2 in all colon segments. Analysis was performed for a non-inferiority margin of 5%, a 95% statistical power and one-sided 0.05 significance level. RESULTS: A total of 855 patients were randomized. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1-day LRD group vs 96.9% in the 3-day LRD group achieved the primary outcome (P-value for non-inferiority < 0.001). The percentage of patients with BBPS scores ≥ 8 was superior in the 1-day LRD group (254 vs 221 in the 3-day LRD group, P = 0.032). The 1-day regimen was better tolerated than the 3-day diet. 47.7% (vs 28.7%, P < 0.05) of patients rated the 1-day LRD as very easy to follow. CONCLUSION: The 1-day LRD is non-inferior to 3-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.

Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis.

BACKGROUND AND AIMS: TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. METHODS: This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. RESULTS: The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. CONCLUSION: TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.

Utility of histology for the diagnosis of portal hypertensive gastroenteropathy. Concordance between the endoscopic image and gastrointestinal biopsies. Role of the CD34 marker. / Utilidad de la histología para el diagnóstico de la gastroenteropatía por hipertensión portal. Concordancia entre la imagen endoscópica y las biopsias gastrointestinales. Papel del marcador CD34.

INTRODUCTION: Upper gastroscopy in patients with cirrhosis often reveals non-specific lesions, which are usually oriented as portal hypertensive gastropathy (PHG). However, the diagnosis of PHG can be difficult, both from an endoscopic and histological point of view. The study of CD34 expression, which enhances the endothelial cells of the microvasculature, could help the differential diagnosis. The objectives of this study were to evaluate the correlation between endoscopy and histology in the diagnosis of PHG and to assess the utility of CD34 in the diagnosis of PHG. MATERIAL AND METHODS: The results of immunostaining with CD34 gastric fundus biopsies from 100 cirrhotic patients and 20 controls were compared with the endoscopic images. RESULTS: The correlation between the histology and the endoscopic diagnosis of PHG was very low (kappa=0.15). In addition, the measurement of the diameter of the gastric vessels enhanced by the use of immunohistochemical staining (CD34) did not show good correlation with the endoscopic diagnosis (p=.26) and did not provide relevant information for the histological diagnosis of PHG either. DISCUSSION: The correlation between histology and endoscopy is low for the diagnosis of PHG. The use of immunostaining for CD34 does not seem to improve the diagnostic yield of the histological study.

Inter and intra-observer concordance for the diagnosis of portal hypertension gastropathy.

INTRODUCTION: At present there is no fully accepted endoscopic classification for the assessment of the severity of portal hypertensive gastropathy (PHG). Few studies have evaluated inter and intra-observer concordance or the degree of concordance between different endoscopic classifications. OBJECTIVES: To evaluate inter and intra-observer agreement for the presence of portal hypertensive gastropathy and enteropathy using different endoscopic classifications. METHODS: Patients with liver cirrhosis were included into the study. Enteroscopy was performed under sedation. The location of lesions and their severity was recorded. Images were videotaped and subsequently evaluated independently by three different endoscopists, one of whom was the initial endoscopist. The agreement between observations was assessed using the kappa index. RESULTS: Seventy-four patients (mean age 63.2 years, 53 males and 21 females) were included. The agreement between the three endoscopists regarding the presence or absence of PHG using the Tanoue and McCormack classifications was very low (kappa scores = 0.16 and 0.27, respectively). CONCLUSIONS: The current classifications of portal hypertensive gastropathy have a very low degree of intra and inter-observer agreement for the diagnosis and assessment of gastropathy severity.

Hemospray treatment is effective for lower gastrointestinal bleeding.

Acute lower gastrointestinal bleeding (LGIB) is diverse in origin and can be substantial, requiring urgent hemostasis. Hemospray is a promising novel hemostatic agent for upper gastrointestinal bleeding (UGIB). It has been claimed in a small series that the use of Hemospray is also feasible in LGIB. We aimed to expand our knowledge of the application of Hemospray for the treatment of LGIB in a wider range of conditions to further define the optimal patient population for this new therapeutic modality. We analyzed the outcomes of nine unselected consecutive patients with active LGIB treated with Hemospray in two major hospitals in Europe. Initial hemostasis was achieved after Hemospray application in all patients. Rebleeding occurred in two patients (22%) who were on acetyl salicylic acid and presented with spurting bleeds. These preliminary data show that Hemospray can be effective in the management of LGIB, but suggest cautious use for patients on antithrombotic therapy and spurting bleeds.

Hemospray application in nonvariceal upper gastrointestinal bleeding: results of the Survey to Evaluate the Application of Hemospray in the Luminal Tract.

BACKGROUND: Hemospray TM (TC-325) is a novel hemostatic agent licensed for use in nonvariceal upper gastrointestinal bleeding (NVUGIB) in Europe. GOALS: We present the operating characteristics and performance of TC-325 in the largest registry to date of patients presenting with NVUGIB in everyday clinical practice. METHODS: Prospective anonymized data of device performance and clinical outcomes were collected from 10 European centers using the multicentre SEAL survey (Survey to Evaluate the Application of Hemospray in the Luminal tract). TC-325 was used as a monotherapy or as second-line therapy in combination with other hemostatic modalities at the endoscopists' discretion. RESULTS: Sixty-three patients (44 men, 19 women), median age 69 (range, 21 to 98) years with NVUGIB requiring endoscopic hemostasis were treated with TC-325. There were 30 patients with bleeding ulcers and 33 with other NVUGIB pathology. Fifty-five (87%) were treated with TC-325 as monotherapy; 47 [85%; 95% confidence interval (CI), 76%-94%] of them achieved primary hemostasis, and rebleeding rate at 7 days was 15% (95% CI, 5%-25%). Primary hemostasis rate for TC-325 in patients with ulcer bleeds was 76% (95% CI, 59%-93%). Eight patients, who otherwise may have required either surgery or interventional radiology, were treated with TC-325 as second-line therapy after failure of other endoscopic treatments, all of whom achieved hemostasis following the adjunct of TC-325. CONCLUSIONS: This multicentre registry identifies potentially useful characteristics of Hemospray (TC-325) when used either as monotherapy or as a rescue therapy in a wide variety of ulcer and nonulcer NVUGIB.

[The Alliance for the Prevention of Colorectal Cancer in Spain. A civil commitment to society]. / Alianza para la Prevención del Cáncer de Colon en España: un compromiso cívico con la sociedad.

Colorectal cancer (CRC) is the most common malignant tumor in Spain, when men and women are considered together, and the second leading cause of cancer death. Every week in Spain over 500 cases of CRC are diagnosed, and nearly 260 people die from the disease. Epidemiologic estimations for the coming years show a significant increase in the number of annual cases. CRC is a perfectly preventable tumor and can be cured in 90% of cases if detected in the early stages. Population-based screening programs have been shown to reduce the incidence of CRC and mortality from the disease. Unless early detection programs are established in Spain, it is estimated that in the coming years, 1 out of 20 men and 1 out of 30 women will develop CRC before the age of 75. The Alliance for the Prevention of Colorectal Cancer in Spain is an independent and non-profit organization created in 2008 that integrates patients' associations, altruistic non-governmental organizations and scientific societies. Its main objective is to raise awareness and disseminate information on the social and healthcare importance of CRC in Spain and to promote screening measures, early detection and prevention programs. Health professionals, scientific societies, healthcare institutions and civil society should be sensitized to this highly important health problem that requires the participation of all sectors of society. The early detection of CRC is an issue that affects the whole of society and therefore it is imperative for all sectors to work together.

Self-expandable metal stents versus endoscopic balloon dilation for the treatment of strictures in Crohn's disease (ProtDilat study): an open-label, multicentre, randomised trial.

BACKGROUND: Endoscopic balloon dilation (EBD) is the established endoscopic treatment for short strictures in Crohn's disease. Fully covered self-expandable metal stents (FCSEMS) have been used for endoscopic treatment of patients for whom EBD was unsuccessful. We aimed to determine the efficacy and safety of the two endoscopic treatments in patients with Crohn's disease with stenosis and compare the mean cost of both treatments. METHODS: This multicentre, open-label, randomised trial was done in 19 tertiary and secondary hospitals in Spain. Patients with Crohn's disease with obstructive symptoms and predominantly fibrotic strictures of less than 10 cm in length were eligible for inclusion. We excluded patients with stenosis treated with SEMS or EBD in the previous year and stenosis not accessible to a colonoscope. Patients were randomly assigned (1:1) to receive either EBD (EBD group) or FCSEMS (FCSEMS group) using a digital en-block randomisation system (block size of four). In the EBD group, dilation was done with a CRE Boston Scientific (Marlborough, MA, USA) pneumatic balloon with the diameter set at the discretion of the endoscopist; a maximum of two sessions of dilation were allowed with a minimum interval of 15-30 days between them. In the FCSEMS group, a 20 mm diameter Taewoong (Gimpo-si, South Korea) fully covered metal stent was placed; stent length was set at the discretion of the endoscopist. The primary outcome was to assess the efficacy of the endoscopic treatment, defined by the proportion of patients free of a new therapeutic intervention (EBD, FCSEMS, or surgery) due to symptomatic recurrence at 1 year of follow-up. Patients were analysed according to the intention-to-treat principle. Adverse events were recorded for all the patients; events were considered associated to be with the procedure when a causal association was possible, probable, or definite. This trial is registered with ClinicalTrials.gov, NCT02395354. FINDINGS: From Aug 28, 2013, to Oct 9, 2017, we assessed the eligibility of 99 patients, of whom 19 (19%) patients were excluded. Thus, 80 (81%) patients were randomly assigned to treatment: 39 (49%) patients to the FCSEMS group and 41 (51%) patients to the EBD group. 33 (80%) of 41 patients in the EBD group and 20 (51%) of 39 patients in the FCSEMS group were free of a new therapeutic intervention at 1 year (odds ratio [OR] 3·9 [95% CI 1·4-10·6]; p=0·0061). Two (3%) of 80 patients had severe adverse events (one [2%] patient in the EBD group and one [3%] patient in the FCSEMS group); both patients had perforations. INTERPRETATION: EBD is more effective than FCSEMS for Crohn's disease strictures, with a good safety profile for both treatments. FUNDING: Spanish National Institute of Health, Foundation of Spanish Society of Digestive Endoscopy, Catalan Society of Gastroenterology, and Taweoong.

Has H. pylori prevalence in bleeding peptic ulcer been underestimated? A meta-regression.

OBJECTIVES: It has been suggested that prevalence of Helicobacter pylori (Hp) in peptic ulcer bleeding (PUB) is lower than that in non-complicated ulcers. As Hp infection is elusive in PUB, we hypothesized that this low prevalence could be related to an insufficiently intensive search for the bacteria. The aim of the study was to evaluate whether the prevalence of Hp in PUB depends on the diagnostic methods used in a given study. METHODS: A systematic review was performed of studies assessing the prevalence of Hp infection in patients with PUB. Data were extracted in duplicate. Univariate and multivariate random-effects meta-regression analyses were performed to determine the factors that explained the differences in Hp prevalence between studies. RESULTS: The review retrieved 71 articles, including 8,496 patients. The mean prevalence of Hp infection in PUB was 72%. The meta-regression analysis showed that the most significant variables associated with a high prevalence of Hp infection were the use of a diagnostic test delayed until at least 4 weeks after the PUB episode-odds ratio: 2.08, 95% confidence interval: 1.10-3.93, P=0.024-and a lower mean age of patients-odds ratio: 0.95 per additional year, 95% confidence interval: 0.92-0.99, P=0.008. CONCLUSIONS: Studies that performed a delayed test and those including younger patients found a higher prevalence of Hp, approaching that recorded in cases of non-bleeding ulcers. These results suggest that the low prevalence of Hp infection described in PUB may be related to the methodology of the studies and to patients' characteristics, and that the true prevalence of Hp in PUB is still to be determined. Our data also support the recent recommendations of the International Consensus on Non-Variceal Upper Gastrointestinal Bleeding regarding the performance of a delayed diagnostic test when Hp tests carried out during the acute PUB episode are negative.

[OVESCO: a promising system for endoscopic closure of gastrointestinal tract perforations]. / OVESCO: un sistema prometedor de cierre endoscópico de las perforaciones del tracto digestivo.

Perforations of the gastrointestinal tract are a significant source of morbidity in clinical practice. Surgery has been the standard of care. However, endoscopic treatment with clips can be used when perforations are small. The development of natural orifice transluminal endoscopic surgery (NOTES) has substantially contributed to research in this field, such as the over the scope clip (OVESCO or OTSC). This system is one of the most promising technologies for closure of perforations of the gastrointestinal tract because of its efficacy, safety and rapidity. Other indications include severe gastrointestinal bleeding, fistulae, anastomotic leaks, and bariatric surgery anastomosis remodelling. This article describes the OVESCO system from its initial design to its introduction in clinical practice.

Endoscopist's Judgment Is as Useful as Risk Scores for Predicting Outcome in Peptic Ulcer Bleeding: A Multicenter Study.

Background: Guidelines recommend using prognostic scales for risk stratification in patients with non-variceal upper gastrointestinal bleeding. It remains unclear whether risk scores offer greater accuracy than clinical evaluation. Objective: Compare the diagnostic accuracy of the endoscopist's judgment against different risk-scoring systems (Rockall, Glasgow-Blatchford, Baylor and the Cedars-Sinai scores) for predicting outcomes in peptic ulcer bleeding (PUB). Methods: Between February 2006 and April 2010 we prospectively recruited 401 patients with peptic ulcer bleeding; 225 received endoscopic treatment. The endoscopist recorded his/her subjective assessment ("endoscopist judgment") of the risk of rebleeding and death immediately after endoscopy for each patient. Independent evaluators calculated the different scores. Area under the receiver-operating-characteristics (ROC) curve, sensitivity, specificity, positive and negative predictive values were calculated for rebleeding and mortality. Results: The areas under ROC curve of the endoscopist's clinical judgment for rebleeding (0.67-0.75) and mortality (0.84-0.9) were similar or even superior to the different risk scores in both the whole group and in patients receiving endoscopic therapy. Conclusions: The accuracy of the currently available risk scores for predicting rebleeding and mortality in PUB patients was moderate and not superior to the endoscopist's judgment. More precise prognostic scales are needed.

Accuracy of diagnostic tests for Helicobacter pylori: a reappraisal.

BACKGROUND: Despite many changes, no large studies comparing the different diagnostic tests for Helicobacter pylori have been performed in the past 10 years. In this time, monoclonal stool antigen immunoassays and in-office 13C-urea breath tests (UBTs) have appeared. The aim of this study was to evaluate the accuracy of invasive and noninvasive tests in a large series of dyspeptic patients. METHODS: A total of 199 dyspeptic patients who had not previously been treated for H. pylori infection were prospectively enrolled. Noninvasive analyses included a commercial infrared-based UBT and a commercially available stool test. Biopsy-based tests included histological examination and a rapid urease test. A patient was considered to be infected when at least 2 test results were positive. Sensitivity, specificity, positive and negative predictive values, and 95% confidence intervals were calculated. The test results were compared using the McNemar test. RESULTS: Rates of positive test results were similar (54%) for the rapid urease test, histopathological examination, and the stool test. By contrast, 75% of UBT results were positive, and the UBT was associated with a very low specificity (60%). For this reason, the delta cutoff value for the UBT was recalculated as 8.5%. Sensitivities and specificities with this new cutoff value were 95% and 100%, respectively, for the rapid urease test; 94% and 99%, respectively, for histopathological examination; 90% and 93%, respectively, for the stool test; and 90% and 90%, respectively, for the UBT. CONCLUSIONS: Histological examination and rapid urease testing showed excellent diagnostic reliability. The stool test seems to be a good, noninvasive alternative to endoscopy-based tests. By contrast, the infrared-based UBT evaluated in our study showed a lower than expected performance, which was partially corrected when the cutoff value for the test was recalculated.

Diagnostic utility of nasogastric tube aspiration and the ratio of blood urea nitrogen to creatinine for distinguishing upper and lower gastrointestinal tract bleeding. / Eficacia diagnóstica de la sonda nasogástrica y de la relación nitrógeno ureico en sangre (BUN)/creatinina para distinguir el origen alto o bajo de la hemorragia digestiva.

OBJECTIVES: The American College of Gastroenterology's 2016 clinical guidelines for treating lower gastrointestinal (GI) tract bleeding recommends evaluating of nasogastric tube aspiration and the ratio of blood urea nitrogen (BUN) to creatinine to differentiate upper from lower GI bleeds. However, the evidence base to support recommending these 2 diagnostic variables is low. This study aimed to evaluate the diagnostic utility of nasogastric tube aspiration and the BUN-to-creatinine ratio for distinguishing between upper and lower GI bleeding. MATERIAL AND METHODS: We conducted a systematic review of the literature to find studies reporting the diagnostic precision of the BUN-to-creatinine ratio and nasogastric aspiration in patients with GI bleeding without hematemesis. RESULTS: The sensitivity of both methods is low for detecting upper GI bleeding. Both blood in the aspirate and an elevated BUN-to-creatinine ratio significantly increase the probability of finding an upper GI source. The positive likelihood ratio varies from positive 2 to 11. However, the sensitivity of both tests for a diagnosis of upper GI bleeding is very low (negative likelihood ratio of 0.6). CONCLUSION: A negative result on either of the 2 diagnostic tests provides little useful information and does not firmly rule out an upper GI bleed. Nasogastric tube aspiration cannot be recommended for distinguishing between upper and lower GI bleeding. If the diagnosis is in doubt, endoscopic exploration of the upper GI tract is necessary.

OBJETIVO: La guía clínica para el tratamiento de la hemorragia digestiva (HD) baja del American College of Gastroenterology publicada en el año 2016 defiende la valoración del aspirado por sonda nasogástrica (SNG) y la evaluación de la relación nitrógeno ureico en sangre (BUN)/creatinina para diferenciar el origen alto o bajo de la HD. Sin embargo, la recomendación de ambas se realiza con un grado de evidencia bajo. El objetivo de este estudio es evaluar la eficacia diagnóstica del aspirado por SNG y la relación BUN/creatinina para diferenciar el origen de una HD. METODO: Se realizó una revisión sistemática de la literatura para identificar los estudios que evalúan la precisión diagnóstica de la relación BUN/creatinina y el aspirado por SNG en pacientes con HD sin hematemesis. RESULTADOS: Ambos métodos tienen una baja sensibilidad para detectar un sangrado digestivo alto. Tanto el aspirado hemático como la relación BUN/creatinina elevada aumentan significativamente la probabilidad de una HD alta. La razón de verosimilitud positiva varía de 2 a 11. Sin embargo, la sensibilidad de ambas pruebas para la HD alta fue muy baja (razón de verosimilitud negativa alrededor de 0,6). CONCLUSIONES: Un resultado negativo en cualquiera de las dos pruebas proporciona poca información y no permite descartar con seguridad una HD alta. Por ello, no se puede recomendar el uso del aspirado por SNG para descartar un origen alto de la HD. Si existe duda diagnóstica es necesario la realización de una endoscopia digestiva alta.

Remission on thiopurinic immunomodulators normalizes quality of life and psychological status in patients with Crohn's disease.

BACKGROUND: Thiopurinic immunomodulators are effective for maintaining symptom remission in Crohn's disease. Little is known, however, about their effect on patients' quality of life or psychological well-being. The present study aimed to determine whether remission induced by thiopurinic immunomodulators returns levels of quality of life and psychological well-being to normal. MATERIALS AND METHODS: A case-control study was performed. Cases were 33 patients with Crohn's disease treated with azathioprine or 6-mercaptopurine and in stable remission for at least 6 months. Sixty-six healthy individuals matched 2:1 by age and sex and 14 patients with active Crohn's disease were included as control groups. Quality of life was evaluated with the Short Form (SF-36) questionnaire, and the respective Hamilton rating scales were used for anxiety and depression. ANOVA with Bonferroni's correction was used for multiple comparisons. RESULTS: SF-36 global scores were 85 in the study group, 85 in healthy controls (P = 1), and 58.6 in patients with active disease (P < 0.001 for the comparison with the other 2 groups). The differences between values were 0 (95% CI -4-4), 26.4 (95% CI 20-32), and 26.4 (95% CI 19-33), respectively. The respective anxiety and depression scores were 6.5, 5.5, and 16.2 and 3.7, 3.3, and 10.9. No significant differences were observed in any of the SF-36 domains between case and control groups, whereas in patients with active disease, all domains were significantly worse. CONCLUSIONS: Thiopurinic immunomodulator-induced remission restores normal levels of quality of life and psychological well-being in Crohn's disease patients.

Diagnostic accuracy of three monoclonal stool tests in a large series of untreated Helicobacter pylori infected patients.

OBJECTIVES: Immunochromatographic tests need to be improved in order to enhance their reliability. Recently, several new kits have appeared on the market. The objective was to evaluate the diagnostic accuracy of three monoclonal rapid stool tests - the new Uni-Gold™ H.pylori Antigen (Trinity Biotech, Ireland), the RAPID Hp StAR (Oxoid Ltd., UK) and the ImmunoCard STAT! HpSA (Meridian Diagnostics, USA) - for detecting H. pylori infection prior to eradication treatment. DESIGN AND METHODS: Diagnostic accuracy (sensitivity and specificity) and reliability (concordance between observers) were evaluated in 250 untreated consecutive dyspeptic patients. The gold standard for diagnosing H. pylori infection was defined as the concordance of two or more of rapid urease test (RUT), histopathology and urease breath test (UBT) or positive culture in isolation. Readings of immunochromatographic tests were performed by two different observers. Sensitivity, specificity, positive and negative predictive values and 95% confidence intervals were calculated. Sensitivity and specificity were compared using the McNemar test. RESULTS: The three tests showed a good correlation, with Kappa values>0.9. RAPID Hp StAR had a sensitivity of 91%-92% and a specificity ranging from 77% to 85%. Its sensitivity was higher than that of Uni-Gold™ H.pylori Antigen and ImmunoCard STAT! HpSA (p<0.01). Uni-Gold™ H.pylori Antigen kit showed a sensitivity of 83%, similar to ImmunoCard STAT! HpSA. Specificity of Uni-Gold™ H.pylori Antigen approached 90% (87-89%) and was superior to that of RAPID Hp StAR (p<0.01). CONCLUSIONS: Uni-Gold™ H.pylori Antigen and ImmunoCard STAT! HpSA present similar levels of diagnostic accuracy. RAPID Hp StAR was the most sensitive but less reliable of the three immunochromatographic stool tests. None are as accurate and reliable as UBT, RUT and histology.

Occult H. pylori infection partially explains 'false-positive' results of (13)C-urea breath test.

BACKGROUND: In a previous study, UBiT-100 mg, (Otsuka, Spain), a commercial (13)C-urea breath test omitting citric acid pre-treatment, had a high rate of false-positive results; however, it is possible that UBiT detected low-density 'occult' infection missed by other routine reference tests. We aimed to validate previous results in a new cohort and to rule out the possibility that false-positive UBiT were due to an 'occult' infection missed by reference tests. METHODS: Dyspeptic patients (n = 272) were prospectively enrolled and UBiT was performed, according to the manufacturer's recommendations. Helicobacter pylori infection was determined by combining culture, histology and rapid urease test results. We calculated UBiT sensitivity, specificity, positive and negative predictive values (with 95% CI). In addition, we evaluated 'occult' H. pylori infection using two previously-validated polymerase chain reaction (PCR) methods for urease A (UreA) and 16 S sequences in gastric biopsies. We included 44 patients with a false-positive UBiT, and two control groups of 25 patients each, that were positive and negative for all H. pylori tests. RESULTS: UBiT showed a false-positive rate of 17%, with a specificity of 83%. All the positive controls and 12 of 44 patients (27%) with false-positive UBiT were positive for all two PCR tests; by contrast, none of our negative controls had two positive PCR tests. CONCLUSIONS: UBiT suffers from a high rate of false-positive results and sub-optimal specificity, and the protocol skipping citric acid pre-treatment should be revised; however, low-density 'occult' H. pylori infection that was undetectable by conventional tests accounted for around 25% of the 'false-positive' results.

[Testing a new in-office test for determination of faecal Helicobacter pylori antigen]. / Evaluación de un nuevo test rápido para la detección de Helicobacter pylori en heces.

BACKGROUND: To date, the search for an in-office reliable test for Helicobacter pylori infection has been unsuccessful. The aim of the present study was to evaluate a new immunocromatographic in-office test using monoclonal antibodies to determine the presence of Helicobacter pylori antigen in faeces (Stick H. pyl, Operon S.A. Zaragoza). We compared its reliability and reproducibility to the currently available test (HpSA, EIA, Premier Platinum HpSA, Meridian Diagnosis Inc, Cincinnati, Ohio). PATIENTS AND METHOD: 71 consecutive dyspeptic patients were enrolled. Helicobacter pylori status was determined by rapid urease test and Giemsa stain of antral biopsy. Patients with a positive result in the two tests were considered as infected and those with a negative result in both tests were regarded as not infected. Faecal Helicobacter pylori antigen was tested twice by means of HpSA. Four consecutive determinations of Stick H. pyl were also performed. We calculated sensitivity, specificity and positive and negative predictive values of each determination. Concordance between determinations was estimated by the kappa statistics. RESULTS: Forty-eight of 68 patients were infected by Helicobacter pylori. Sensitivity, specificity and positive and negative predictive values were 89-96%, 60-70% 85-88% and 74-87%, respectively, for Stick H. pyl and 70-75%, 60-85%, 85-92% and 55-80%, respectively, for HpSA. Correlation coefficients were 0.82-0.93 for Stick H. pyl and 0.57 for HpSA. CONCLUSIONS: The new Stick H. pyl test shows excellent sensitivity and reproducibility for diagnosis of H. pylori infection. Its reliability appears to be far better than that of HpSA.