Fernando Borda

Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-steroidal anti-inflammatory drugs, aspirin and combinations

Background: The risks and benefits of coxibs, non-steroidal anti-inflammatory drugs (NSAIDs), and aspirin treatment are under intense debate. Objective: To determine the risk of peptic ulcer upper gastrointestinal bleeding (UGIB) associated with the use of coxibs, traditional NSAIDs, aspirin or combinations of these drugs in clinical practice. Methods: A hospital-based, case–control study in the general community of patients from the National Health System in Spain. The study included 2777 consecutive patients with endoscopy-proved major UGIB because of the peptic lesions and 5532 controls matched by age, hospital and month of admission. Adjusted relative risk (adj RR) of UGIB determined by conditional logistic regression analysis is provided. Results: Use of non-aspirin-NSAIDs increased the risk of UGIB (adj RR 5.3; 95% confidence interval (CI) 4.5 to 6.2). Among non-aspirin-NSAIDs, aceclofenac (adj RR 3.1; 95% CI 2.3 to 4.2) had the lowest RR, whereas ketorolac (adj RR 14.4; 95% CI 5.2 to 39.9) had the highest. Rofecoxib treatment increased the risk of UGIB (adj RR 2.1; 95% CI 1.1 to 4.0), whereas celecoxib, paracetamol or concomitant use of a proton pump inhibitor with an NSAID presented no increased risk. Non-aspirin antiplatelet treatment (clopidogrel/ticlopidine) had a similar risk of UGIB (adj RR 2.8; 95% CI 1.9 to 4.2) to cardioprotective aspirin at a dose of 100 mg/day (adj RR 2.7; 95% CI 2.0 to 3.6) or anticoagulants (adj RR 2.8; 95% CI 2.1 to 3.7). An apparent interaction was found between low-dose aspirin and use of non-aspirin-NSAIDs, coxibs or thienopyridines, which increased further the risk of UGIB in a similar way. Conclusions: Coxib use presents a lower RR of UGIB than non-selective NSAIDs. However, when combined with low-dose aspirin, the differences between non-selective NSAIDs and coxibs tend to disappear. Treatment with either non-aspirin antiplatelet or cardioprotective aspirin has a similar risk of UGIB.

Clinical patterns and outcomes of ischaemic colitis: results of the Working Group for the Study of Ischaemic Colitis in Spain (CIE study).

Abstract Background. There is a lack of prospective studies evaluating the natural history of colonic ischaemia (CI). We performed such a study to evaluate the clinical presentation, outcome, and mortality as well as clinical variables associated with poor prognosis. Methods. An open, prospective, and multicentre study was conducted in 24 Spanish hospitals serving a population of 3.5 million people. The study included only patients who met criteria for definitive or probable CI. A website (www.colitisisquemica.org) provided logistical support. Results. A total of 364 patients met criteria for inclusion. CI was suspected clinically in only 24.2% of cases. The distribution of clinical patterns was as follows: reversible colopathy (26.1%), transient colitis (43.7%), gangrenous colitis (9.9%), fulminant pancolitis (2.5%), and chronic segmental colitis (17.9%). A total of 47 patients (12.9%) had an unfavorable outcome as defined by mortality and/or the need for surgery. Multivariate analysis identified the following signs as independent risk factors for an unfavorable outcome: abdominal pain without rectal bleeding [odds ratio (OR) 3.9; 95% confidence interval (CI) = 1.6–9.3], non-bloody diarrhoea (OR 10; 95% CI = 3.7–27.4), and peritoneal signs (OR 7.3; 95% CI = 2.7–19.6). Unfavorable outcomes also were more frequent in isolated right colon ischaemia (IRCI) compared with non-IRCI (40.9 vs. 10.3%, respectively; p < 0.0001). The overall mortality rate was 7.7%. Conclusions. The clinical presentation of CI is very heterogeneous, perhaps explaining why clinical suspicion of this disease is so low. The presence of IRCI, and occurrence of peritoneal signs or onset of CI as severe abdominal pain without bleeding, should alert the physician to a potentially unfavorable course.

Long-Term Follow-Up of 1,000 Patients Cured of Helicobacter pylori Infection Following an Episode of Peptic Ulcer Bleeding

OBJECTIVES:To evaluate the effect of Helicobacter pylori (H. pylori) eradication on ulcer bleeding recurrence in a prospective, long-term study including 1,000 patients.METHODS:Patients with peptic ulcer bleeding were prospectively included. Prior non-steroidal anti-inflammatory drug (NSAID) use was not considered exclusion criteria. H. pylori infection was confirmed by rapid urease test, histology, or 13C-urea breath test. Several eradication therapies were used. Subsequently, ranitidine 150 mg o.d. was administered until eradication was confirmed by 13C-urea breath test 8 weeks after completing therapy. Patients with therapy failure received a second, third, or fourth course of eradication therapy. Patients with eradication success did not receive maintenance anti-ulcer therapy and were controlled yearly with a repeat breath test. NSAID use was not permitted during follow-up.RESULTS:Thousand patients were followed up for at least 12 months, with a total of 3,253 patient-years of follow-up. Mean age 56 years, 75% males, 41% previous NSAID users. In all, 69% had duodenal ulcer, 27% gastric ulcer, and 4% pyloric ulcer. Recurrence of bleeding was demonstrated in three patients at 1 year (which occurred after NSAID use in two cases, and after H. pylori reinfection in another one), and in two more patients at 2 years (one after NSAID use and another after H. pylori reinfection). The cumulative incidence of rebleeding was 0.5% (95% confidence interval, 0.16–1.16%), and the incidence rate of rebleeding was 0.15% (0.05–0.36%) per patient-year of follow up.CONCLUSION:Peptic ulcer rebleeding virtually does not occur in patients with complicated ulcers after H. pylori eradication. Maintenance anti-ulcer (antisecretory) therapy is not necessary if eradication is achieved. However, NSAID intake or H. pylori reinfection may exceptionally cause rebleeding in H. pylori-eradicated patients.

Eradication of Helicobacter pylori for the Prevention of Peptic Ulcer Rebleeding

Aim:  To evaluate the effect of Helicobacter pylori eradication on ulcer bleeding recurrence in a prospective, long‐term study including more than 400 patients.

Endoscopic localization of colorectal cancer: Study of its accuracy and possible error factors

INTRODUCTION accurate preoperative localization of colorectal cancer (CRC) is very important, with a wide range of published error rates. AIMS to determine accuracy of endoscopic localization of CRC in comparison with preoperative computed tomography (CT). To analyse variables that could be associated with a wrong endoscopic localization. PATIENTS AND METHODS endoscopic and CT localization of a series of CRC without previous surgery were reviewed. We studied the concordance between endoscopic and radiologic localization against operative findings comparing accuracy of endoscopy and CT. We analysed the frequency of wrong endoscopic diagnoses with regard to a series of patient, endoscopy and tumor variables. RESULTS two hundred thirty seven CRC in 223 patients were studied. Concordance with surgical localization was: colonoscopy = 0.87 and CT = 0.69. Endoscopic localization accuracy was:91.1%; CT: 76.2%: p = 0.00001; OR = 3.22 (1.82-5.72). Obstructive cancer presented a higher rate of wrong localization: 18 vs. 5.7% in non-obstructive tumors (p = 0.0034; OR = 3.65 (1.35-9.96). Endoscopic localization mistakes varied depending on tumor location, being more frequent in descending colon: 36.3%, p = 0.014; OR = 6.23 (1.38-26.87) and cecum: 23.1%, p = 0.007; OR = 3.92 (1.20-12.43). CONCLUSIONS endoscopic accuracy for CRC localization was very high and significantly better than CT accuracy. Obstructive tumor and those located in the descending colon or cecum wereassociated with a significant increase of the error risk of CRC endoscopic localization.

Comparación entre dos pruebas del aliento con 13C-urea para el diagnóstico de la infección por Helicobacter pylori: espectrometría de masas frente a infrarrojos

Objetivos Comparar la exactitud de la prueba del aliento empleando un espectrometro de masas de relaciones isotopicas (isotope ratio mass spectrometer [IRMS]) frente a un espectrofotometro de infrarrojos no dispersivo (nondispersive isotope-selective infrared spectrometer [NDIRS]) para el diagnostico de la infeccion por Helicobacter pylori . Metodo Estudio multicentrico en 4 hospitales espanoles. Se incluyeron un grupo de pacientes dispepticos a quienes no se habia administrado tratamiento erradicador previo y otro grupo con ulcera gastrica o hemorragia digestiva por ulcera gastroduodenal en el que se confirmaba la erradicacion de H. pylori . Se utilizo un patron de referencia basado en la histologia y el test rapido de la ureasa. Se realizo la prueba del aliento (TAU-KITR, Isomed S.L., Madrid) con acido citrico y 100 mg de 13C-urea. Se recogieron muestras de aire espirado en tubos y en bolsas para su lectura con el IRMS (ABCA, PDZ, Crewe, Manchester, Reino Unido) y el NDIRS (UBiTIR200, Otsuka Electronics, Co, Osaka, Japon), respectivamente. El endoscopista, el patologo y la persona responsable de la lectura del test de la ureasa y de ambas pruebas del aliento desconocian el estado de infeccion por los demas metodos diagnosticos. Resultados Se incluyo a 41 pacientes. La prevalencia de H. pylori fue del 26%. No se demostraron diferencias al comparar los valores medios (desviacion estandar) obtenidos con el Irms y el ndirs 13 (24) y 14 (25) unidades δ, respectivamente. El area bajo la curva ROC para el IRMS y el NDIRS fue de 0,96. La exactitud diagnostica para el mejor punto de corte con el IRMS y el NDIRS fue, respectivamente: sensibilidad del 90 y el 100%; especificidad del 96 y el 89%; valor predictivo positivo del 90 y el 77%; valor predictivo negativo del 96 y el 100%; cociente de probabilidades positivo de 25 y 9,3, y negativo de 0,1 y 0. Se demostro una elevada correlacion entre los valores del IRMS y del NDIRS (ecuacion de regresion lineal, Y = 1,1 + 1,004. X; r = 0,97). Conclusion Los dos equipos que se han utilizado para evaluar la prueba del aliento, IRMS y NDIRS, poseen una similar y elevada exactitud para el diagnostico de la infeccion por H. pylori .

Prevalence of severe esophagitis in Spain. Results of the PRESS study (Prevalence and Risk factors for Esophagitis in Spain: A cross-sectional study)

Background *N.P. and M.P. contributed equally to this study. The current prevalence of esophagitis in southern Europe is unknown. In addition, the risk factors for reflux esophagitis are not fully understood. Objective The objective of this article is to assess the prevalence and risk factors for esophagitis in Spain. Methods A prospective, observational, cross-sectional, multicenter study (PRESS study) was conducted among 31 gastrointestinal endoscopy units throughout Spain. A total of 1361 patients undergoing upper gastrointestinal endoscopy were enrolled. Sociodemographic, clinical and treatment data were recorded. Results A total of 95% of patients were Caucasian and 52% were male (mean age: 53 ± 17 years). The most frequent symptoms prompting endoscopy were heartburn (40%), regurgitation (26%) and dysphagia (15%). Fifty-four percent of patients undergoing endoscopy were receiving proton pump inhibitor (PPI) treatment. Esophagitis (mainly mild-moderate) was present in 154 (12.4%) patients. The severe form was recorded in only 11 (0.8%) patients. Multivariate analysis results indicated that the likelihood of esophagitis was higher in men (OR = 1.91, 95% CI = 1.31–2.78), in patients with high GERD-Q scores (OR = 1.256, 95% CI = 1.176–1.343), weight increase (OR = 1.014, 95% CI = 1.003–1.025) and high alcohol consumption (OR = 2.49, 95% CI = 1.16–5.36). Conclusion Severe esophagitis is a rare finding in the Spanish population. Male gender, high GERD-Q score, weight increase and high alcohol consumption are main risk factors for its appearance.

Prospective observational study of the incidental findings on endoscopic ultrasonography: Should a complete exploration always be performed?

Objectives. To quantify the additional non-suspected new diagnoses made on upper endosonography (EUS) which were unknown before the procedure, and to analyse their influence on the management of patients. A further objective was to evaluate the influence that previous radiological or endoscopic explorations have on the capacity of EUS to diagnose these unsuspected lesions. Material and methods. During a 2-year period every patient sent to our unit for upper EUS underwent a complete investigation, after signing an informed consent document. An upper EUS was considered as complete whenever the gut wall, pancreas, biliary tract, ampulla, large abdominal vessels, liver, spleen, left adrenal gland, posterior mediastinum and thyroid lobes had been explored. An additional diagnosis (AD) was defined as a diagnosis made on EUS that was previously unknown and not suspected. A significant additional diagnosis (SAD) was defined as an AD that required further study. The results of complementary explorations carried out before EUS were registered. Results. A total of 239 patients were included in the study. ADs were found in 92 patients (38.5%), which were considered to be SADs in 27 patients (11.3%). Those patients had previously undergone computed tomography (CT) and those who underwent more than one exploration had fewer incidences of ADs on EUS (p=0.03 and p=0.02, respectively). No exploration alone or in combination with others showed any influence on the capacity of EUS to find a SAD (p >0.05). Conclusions. In our series, an AD was found on upper endosonography in 38.5% of the patients studied, and a SAD in 11.3%. The probability of finding a SAD on EUS is not influenced by previous endoscopic or radiologic explorations.

Estudio de coste-efectividad del empleo de somatostatina para la disminución de pancreatitis agudas post-CPRE

Objetivos Estudios recientes demuestran que la inyeccion intravenosa de somatostatina previa a la practica de una CPRE se acompana de una significativa reduccion de la tasa de pancreatitis aguda post-CPRE. Ante la falta de datos en nuestro medio, hemos querido estudiar el posible beneficio economico de la administracion de somatostatina, obtenido a traves de la disminucion de los costes debidos a las pancreatitis agudas post-CPRE. Material y Metodo Estudio teorico de los costes directos de la pancreatitis aguda post-CPRE, mediante el metodo del “arbol de decisiones” de Markov. Se comparan los costes del grupo pretratado con administracion intravenosa de 3 mg de somatostatina con respecto al grupo control. Se aceptan unas tasas de pancreatitis post-CPRE del 10% en el grupo control y del 3% en grupo con somatostatina. Los costes de los distintos tipos de pancreatitis, sin y con complicaciones y con actuacion quirurgica, se han basado en los pesos por GDR aplicados por el Ministerio de Sanidad y en el Contrato-programa del Servicio Navarro de Salud para 1999. Se ha efectuado un analisis de sensibilidad para precisar a partir de que tasa de pancreatitis post-CPRE se obtendria un beneficio economico en el grupo pretratado con somatostatina. Resultados El coste medio teorico por exploracion fue de 121.640 pesetas para el grupo control y de 105.539 pesetas para los tratados con somatostatina, con un ahorro por caso del 13,26% (16.101 pesetas). El analisis de sensibilidad demuestra que con la premedicacion se obtiene un beneficio economico a partir de tasas de pancreatitis del 4,2% en el grupo control. Conclusiones Con independencia del beneficio clinico que significa la reduccion de pancreatitis post-CPRE, la administracion de somatostatina supone un ahorro de 16.101 pesetas por paciente. Aceptando que la tasa de pancreatitis en el grupo tratado se reduce de manera proporcional, el analisis de sensibilidad pone de manifiesto que con la premedicacion se obtiene un beneficio economico a partir de tasas de pancreatitis del 4,2% en el grupo control.

3351 Iatrogenic perforation in diagnostic colonoscopy related to the type of sedation.

INTRODUCTION: Diagnostic colonoscopy is a safe procedure, although a iatrogenic perforation rate ranging from 0.04% to 0.9% has been reported by different authors. The influence of deep sedation in the occurrence of this complication remains controversial as it eliminates pain due to excessive insuflation and endoscope loop formation, both potential causes of colonic perforation. The aim of this study is to evaluate the incidence of colonic perforation during diagnostic colonoscopy and the role of the type of sedation. MATERIAL AND METHOD: 7.286 consecutive diagnostic colonoscopies performed during a 3 year period were included in the study. Patients were randomized to undergo deep sedation with propofol I.V. (Group A; n=4.005) or conscious sedation with diazepan I.V. (Group B; n=3.281). Therapeutic colonoscopies were excluded from the protocol. Incidence of iatrogenic perforation was analyzed in both groups, evaluating patients characteristics and both endoscopist (senior/trainee) and endoscopy assistant experience. Fisher test was used for statistical analysis. RESULTS: 7 perforations took place in group A (0.17%) and 2 in group B (0.06%) (p=0.03). Among those perforations in group A, 6 of them (0.32%) occured during the first 18 months of the study, whereas only one (0.04%) occured during the following 18 months (p = 0.06). No significant differences were found concerning patient characteristics or experience of the endoscopy team. CONCLUSIONS: 1. Diagnostic colonoscopy performance under deep sedation has a higher rate of iatrogenic perforation although without statistical significance. 2. As this increment concentrates within the initial period of using deep sedation, extreme caution must be taken until experience is acquired in order to avoid this complication.