Upper gastrointestinal endoscopy (UGE) is currently recommended in cirrhotic patients to detect the presence of esophageal varices (EV). Spleen stiffness measurement (SSM) with FibroScan has been used for this purpose, showing variable sensitivity (S) and specificity (Sp). The aim of this study was to evaluate the capability of SSM to detect the presence and size of EV in cirrhotic patients in comparison to other noninvasive modalities. Patients and methods : Sixty-six patients with cirrhosis who had undergone UGE in the previous 6 months underwent SSM and liver stiffness measurement (LSM) using FibroScan. Biochemical parameters and ultrasonography data were also collected to calculate other noninvasive indexes. Results : Valid spleen stiffness measurements were obtained for 60 of the 66 patients initially included in the study (90.1%). In the multivariate analysis only splenomegaly and SSM were predictive of esophageal varices. SSM was the most accurate diagnostic tool, obtaining an area under the ROC curve of 0.8 for values below 48 KPascals, with S = 87%, Sp = 69%, and 76.7% of successfully diagnosed patients. Conclusions : SSM with FibroScan was significantly higher for cirrhotic patients with EV. Our study suggests that spleen stiffness may be useful to identify cirrhotic patients at risk of having EV, although further studies are needed.

Introduction: the elevated risk of complications and technical complexity of endoscopic submucosal dissection (ESD) has limited its implementation in our medical system.Objective: to design and evaluate a training program for learning the ESD technique.Methods: four endoscopists with no experience with ESD underwent a 4-step training program: 1) review of the existing literature, didactic material, and theoretical aspects of ESD; 2) ESD training in an ex-vivo animal model; 3) ESD training in an in-vivo animal model (supervised by ESD expert); and 4) ESD performance in a patient. A standard gastroscope and an ESD knife (IT, Flex or Hook-knife Olympus') were employed. The classical ESD technique was performed: rising of the lesion, circumferential incision, and submucosal dissection.Results: ex-vivo animal model: 6 x swine stomach/esophagus -cost < 100 euro; 6 x ESD: antrum (n = 2), body (n = 3) and fundus/cardia (n = 1)-, size of resected specimen: 4-10 cm; ESD duration: 105-240 minutes: therapeutic success: 100% complications: perforation (1/6: 16%) sealed with clips. In-vivo animal model: 6 ESD (antrum/body of stomach: 4: esophagus: 2); size: 2-5 cm; duration: 40-165 minutes; success: 100%; complications: 0%. Patient: ESD of a gastric lesion located in the antrum/body; size: 3 cm: duration 210 minutes; a complete resection was achieved; no complications.Conclusions: the results of the present study support the usefulness of this model for learning ESD in our system.

Introduction: the elevated risk of complications and technical complexity of endoscopic submucosal dissection (ESD) has limited its implementation in our medical system. Objective: to design and evaluate a training program for learning the ESD technique. Methods: four endoscopists with no experience with ESD underwent a 4-step training program: 1) review of the existing literature, didactic material, and theoretical aspects of ESD; 2) ESD training in an ex-vivo animal model; 3) ESD training in an in-vivo animal model(supervised by ESD expert); and 4) ESD performance in a patient. A standard gastroscope and an ESD knife (IT, Flex or Hook-knife Olympus®) were employed. The classical ESD technique was performed: rising of the lesion, circumferential incision, and submucosal dissection. Results: ex-vivo animal model: 6 x swine stomach/esophagus -cost < 100 euro; 6 x ESD: antrum (n = 2), body (n = 3) and fundus/cardia (n = 1)-; size of resected specimen: 4-10 cm; ESD duration: 105-240 minutes; therapeutic success: 100%; complications: perforation (1/6: 16%) sealed with clips. In-vivo animal model: 6 ESD (antrum/body of stomach: 4; esophagus: 2); size: 2-5 cm; duration: 40-165 minutes; success: 100%; complications: 0%. Patient: ESD of a gastric lesion located in the antrum/body; size: 3 cm; duration 210 minutes; a complete resection was achieved; no complications. Conclusions: the results of the present study support the usefulness of this model for learning ESD in our system.

La prevalencia de ERGE (Enfermedad por Reflujo GastroEsofágico) es alta y su estimación en la población adulta está alrededor del 20 al 40%. Tanto la ERGE erosiva, como la no erosiva, presentan síntomas típicos como el reflujo y la reurgitación que han demostrado disminuir la calidad de vida de dichos pacientes. Los AINEs (Anti-Inflamatorios No Esteroideos) son los fármacos más utilizados en todo el mundo, a pesar de que su uso se relaciona con erosiones esofágicas y estenosis. Sin embargo, la incidencia de ERGE en pacientes tratados con AINEs no ha sido aún bien estudiada. Evaluar la incidencia de síntomas de ERGE en pacientes bajo tratamiento agudo (entre 15 y 30 días) con AINEs. Estudio observacional, multicéntrico, y retrospectivo. El número de investigadores fue proporcional para cada una de las 17 comunidades autónomas españolas. El estudio comenzó en abril de 2007, finalizando en julio del mismo año. Un total de 2.379 pacientes completaron el estudio, de los cuales 2.259 fueron evaluables. En nuestro estudio, los pacientes que estuvieron tratados con AAS (ácido acetil-salicílico) se analizaron por separado de los que estuvieron en tratamiento con otro AINE diferente. Por consiguiente, el 21% de los participantes estuvo tratado con AAS, mientras que el resto de los pacientes (79%) estuvo tratado con otro AINE distinto a la aspirina. Curiosamente, el 44,1% de los pacientes tratados con AAS, también estaba recibiendo otro AINE concomitantemente. Un total de 944 (41,8%) pacientes reportaron tener síntomas de ERGE después del tratamiento antiinflamatorio, comenzando éstos 4,9 días (IC 95%=4,67; 5,10) después del inicio del tratamiento con AINEs/AAS. Nuestros resultados preliminares parecen indicar que los síntomas atípicos de la ERGE son más frecuentes en los pacientes que recibían AAS frente a otros AINEs (duración media del tratamiento de 21,1 días). El asma se manifestó 4 veces más en pacientes tratados con aspirina que con el resto de AINEs (4,4% AAS frente al 1,1% AINEs). Además, tanto la tos persistente (24,5% frente a 12,7% respectivamente) como la afonía/disfonía (13,1% AAS frente a 6,2% AINEs), parecen se reportaron con mayor frecuencia con aspirina. También se hallaron diferencias, en otros síntomas atípicos de la ERGE, como por ejemplo la disfagia (12,5% AINEs vs 17,9% AAS), el hipo (6,7% AINEs vs 8,0% AAS), y el dolor torácico (11,7% AINEs vs 16,7% AAS). La pirosis fue el síntoma descrito con más frecuencia, manifestándose en un 66,6% (n=1704) de los pacientes tratados con AINEs/AAS de forma aguda. No es necesario un tratamiento crónico o a largo plazo con AINEs/AAS para provocar síntomas de ERGE. Una terapia aguda con estos antiinflamatorios parece ser capaz de inducir síntomas de ERGE, tanto típicos como atípicos, pudiendo ser la aspirina en varios síntomas el AINE que lo causa con mayor frecuencia.

OBJECTIVE To study histologic gastric mucosa lesions in patients with gastric ulcer disease and to assess their evolution in the year after Helicobacter pylori eradication. METHODS Seventy-three patients with gastric ulcer were prospectively studied. On endoscopy, biopsy specimens were taken from the antrum and gastric body for hematoxylin and eosin staining and urease testing. Serology and 13C-urea breath test were carried out. Fifty-six patients treated for H. pylori infection were monitored with histologic study at months 1, 6 and 12 after therapy to eradicate H. pylori infection. RESULTS In patients with gastric ulcer, the prevalence of H. pylori was 86.3% (95% CI: 76-92%). Similar percentages in patients with chronic gastritis (CG) and in those with active chronic gastritis (ACG) were noted in the antrum and gastric body. However, severe active chronic gastritis was more prevalent in the antrum (p < 0.01). In patients with H. pylori infection who were not treated with non-steroidal anti-inflammatory drugs (NSAIDs), the percentages of both CG and ACG were higher than those observed in patients with both risk factors (p < 0.01) and in those treated with NSAIDs and with no infection (p < 0.0001). The prevalence of glandular atrophy (17.8%; 11-28%) and of intestinal metaplasia (68.5%; 57-78%) was higher in the antrum than in the gastric body (4.1%; 1-11% and 16.4%; 10-26%, respectively) (p < 0.01). In the antrum of patients with successful treatment, the percentages of CG:ACG before treatment and 1, 6, and 12 months after treatment completion were: 100%:97%, 74%:14%, 44%:11% and 11%:2%, respectively. In the gastric body these rates were: 88%:86%, 51%:14%, 23%:4% and 4%:0%. Improvement of CG was observed at month 1 after treatment completion, which was then confirmed at months 6 and 12 (p < 0.01) whereas improvement of ACG was most often achieved at month 1 after treatment completion (p > 0.001). No changes in atrophy and intestinal metaplasia were observed after H. pylori eradication. CONCLUSIONS Histologic gastritis associated with gastric ulcer disease involves both the antrum and gastric body, although prevalence of severe ACG, atrophy and intestinal metaplasia were higher in the antrum. Histologic gastritis were closely related to H. pylori infection but is unrelated to NSAIDs. H. pylori eradication results in progressive CG improvement over the first year, as well as in early ACG improvement (as soon as 1 month after treatment completion); however, atrophy and intestinal metaplasia remain unchanged.

SummaryAim : To study the efficacy of a 7‐day quadruple regimen combining pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection after failure of standard triple therapy.Methods : A prospective study was made of 140 patients infected with H. pylori and diagnosed with peptic ulcer or non‐ulcer dyspepsia in whom triple therapy with proton pump inhibitor, clarithromycin and amoxicillin had failed. The patients were treated with quadruple therapy including pantoprazole, 40 mg twice daily, colloidal bismuth subcitrate, 120 mg four times daily, tetracycline, 500 mg four times daily, and metronidazole, 500 mg three times daily, for 7 days. Two months after completion of therapy, a 13C‐urea breath test was performed to confirm eradication.Results : With quadruple therapy, the H. pylori eradication rates were 82% (95% confidence interval (CI), 75–88%) by ‘intention‐to‐treat’ and 85% (95% CI, 79–91%) by ‘per protocol’. No major side‐effects were observed. No differences in eradication success were observed in relation to underlying disease (peptic ulcer: 85% (95% CI, 76–91%) vs. non‐ulcer dyspepsia: 83% (95% CI, 68–93%)) or smoking habits (smokers: 86% (95% CI, 75–93%) vs. non‐smokers: 83% (95% CI, 71–91%)).Conclusion : Quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole for 7 days is an effective H. pylori eradication treatment for patients in whom standard triple therapy has failed.

The aim of this research was to develop immediate release tablets comprising solid dispersion (IRSDTs) of tadalafil (Td) in a vinylpyrrolidone and vinyl acetate block copolymer (PVP-VA), characterized by improved dissolution profiles. The solid dispersion of Td in PVP-VA (Td/PVP-VA) in a weight ratio of 1:1 (w/w) was prepared using two different processes i.e. spray drying and ball milling. While the former process has been well established in the formulation of IRSDTs the latter has not been exploited in these systems yet. Regardless of the preparation method, both Td/PVP-VA solid dispersions were amorphous as confirmed by PXRD, DSC and FTIR. However, different morphology of particles (SEM) resulted in differences in water apparent solubility and disk intrinsic dissolution rate (DIDR). Both solid dispersions and crystalline Td were successfully made into directly compressible tablets at three doses of Td, i.e. 2.5 mg, 10 mg and 20 mg, yielding nine different formulations (D1–D9). Each of the lots met the requirements set by Ph.Eur. and was evaluated with respect to appearance, diameter, thickness, mass, hardness, friability, disintegration time and content of Td. IRSDTs performed as supersaturable formulations and had significantly improved water dissolution profiles in comparison with equivalent tablets containing crystalline Td and the marketed formulations. Tablets with both spray dried and ball milled Td/PVP-VA revealed the greatest improvement in dissolution depending on the investigated doses, i.e. 2.5 mg and 20 mg, respectively. Also, dissolution of Td from Td/PVP-VA delivered in different forms occurred in the following order: powders > tablets > capsules.

AIM:To study the influence of Helicobacter pylori eradication on basal gastrin and pepsinogen I and II levels in patients with gastric ulcer over a 1-year follow-up period, and to assess the usefulness of these values in confirming H. pylori eradication after treatment.METHODS:Fifty-six patients with gastric ulcer and H. pylori infection were prospectively studied. At the beginning of the study, endoscopy with biopsies for histologic examination and urease testing was carried out, as were 13C-urea breath test and blood samples for determination of gastrin and pepsinogen I and II values by radioimmunoassay and serology. Histologic study, 13C-urea breath test and laboratory determinations were repeated at months 1, 6 and 12 after completion of eradication treatment.RESULTS:H. pylori infection was eradicated in 82.1% of patients. In patients with successful H. pylori eradication, the initial mean gastrin value was 75.5 +/- 39.1 pg/ml, while at 1 month after treatment this value decreased to 49.2 +/- 21 pg/ml (p < 0.0001). No further reductions were noted. Initial pepsinogen I and II values were 104 +/- 58 and 15.8 +/- 10 ng/ml, respectively, whereas at month 1 after treatment these values were 77 +/- 42 and 7.3 +/- 4 ng/ml, respectively (p < 0.0001) and were 72 +/- 41 and 6.7 +/- 3 ng/ml respectively at month 6 (p < 0.01); no further variations were observed thereafter. The area under the ROC curve which reveals eradication through reductions in hormonal values was 0.70 for gastrin, 0.78 for pepsinogen I, 0.93 for pepsinogen II and 0.92 for the pepsinogen I/II ratio. At months 6 and 12 after treatment completion, differences in mean gastrin and pepsinogen I and II values between the patients with normal histologic findings and those with chronic gastritis were significant (p < 0.05).CONCLUSIONS:a) H. pylori eradication is associated with an early fall in basal gastrin values and a progressive decrease in basal pepsinogen I and II values. b) In patients with gastric ulcer, determination of the decrease in basal pepsinogen II levels is a useful and early non-invasive method for confirming eradication. c) Determination of gastrin and pepsinogen I and II values may be useful for assessing improvement in gastritis 6 months after treatment completion.

We present the case of a female patient with atypical gastrointestinal stromal tumor. The young woman presented asymptomatic colonic perforation and showed atypical immunohistochemical findings. The various clinicopathologic characteristics and diagnostic tests, as well as treatment and distinct behavior of these tumors, are discussed.

We present the case of a female patient with atypical gastrointestinal stromal tumor. The young woman presented asymptomatic colonic perforation and showed atypical immunohistochemical findings. The various clinicopathologic characteristics and diagnostic tests, as well as treatment and distinct behavior of these tumors, are discussed.

Aims Helicobacter pylori infection in cirrhotic patients has been associated with episodes of hepatic encephalopathy (HE), although conclusive data are still lacking. This prospective study has evaluated the prevalence of H. pylori infection in 37 patients with advanced cirrhosis of the liver and subclinical hepatic encephalopathy (SHE), diagnosed by changes in psychometric tests and/or electrophysiological tests, as well as the repercussion of H. pylori eradication on ammonaemia and the evolution of this disorder. Results A positive result for H. pylori infection was obtained in 22/37 (59%) patients. Initial fasting blood levels of ammonia were high in both groups. Infected and non-infected patients showed similar levels (62.05 mmol/l v. 62.5 mmol/l), which were lowered by the standard diet, although statistical significance was only reached in the infected patient group (53.05 ± 26 mmol/l;P < 0.05). Infection was eradicated in 19 patients, but no reduction of blood levels of ammonia was observed after H. pylori eradication among infected patients (52.37 ± 29 mmol/l). No change has been found in either group after the administration of diet or antimicrobials with regard to psychometric and/or electrophysiological tests. Conclusions H. pylori infection does not contribute significantly to high blood levels of ammonia in patients with advanced cirrhosis and SHE. Likewise, H. pylori eradication does not induce any improvement in the psychometric and/or electrophysiological tests used to define SHE.

To study the influence of Helicobacter pylori eradication on basal gastrin and pepsinogen I and II levels in patients with gastric ulcer over a 1-year follow-up period, and to assess the usefulness of these values in confirming H. pylori eradication after treatment.Fifty-six patients with gastric ulcer and H. pylori infection were prospectively studied. At the beginning of the study, endoscopy with biopsies for histologic examination and urease testing was carried out, as were 13C-urea breath test and blood samples for determination of gastrin and pepsinogen I and II values by radioimmunoassay and serology. Histologic study, 13C-urea breath test and laboratory determinations were repeated at months 1, 6 and 12 after completion of eradication treatment.H. pylori infection was eradicated in 82.1% of patients. In patients with successful H. pylori eradication, the initial mean gastrin value was 75.5 +/- 39.1 pg/ml, while at 1 month after treatment this value decreased to 49.2 +/- 21 pg/ml (p < 0.0001). No further reductions were noted. Initial pepsinogen I and II values were 104 +/- 58 and 15.8 +/- 10 ng/ml, respectively, whereas at month 1 after treatment these values were 77 +/- 42 and 7.3 +/- 4 ng/ml, respectively (p < 0.0001) and were 72 +/- 41 and 6.7 +/- 3 ng/ml respectively at month 6 (p < 0.01); no further variations were observed thereafter. The area under the ROC curve which reveals eradication through reductions in hormonal values was 0.70 for gastrin, 0.78 for pepsinogen I, 0.93 for pepsinogen II and 0.92 for the pepsinogen I/II ratio. At months 6 and 12 after treatment completion, differences in mean gastrin and pepsinogen I and II values between the patients with normal histologic findings and those with chronic gastritis were significant (p < 0.05).a) H. pylori eradication is associated with an early fall in basal gastrin values and a progressive decrease in basal pepsinogen I and II values. b) In patients with gastric ulcer, determination of the decrease in basal pepsinogen II levels is a useful and early non-invasive method for confirming eradication. c) Determination of gastrin and pepsinogen I and II values may be useful for assessing improvement in gastritis 6 months after treatment completion.

BACKGROUND:To study the influence of Helicobacter pylori eradication on the incidence of ulcer recurrence during 12 months of follow-up in gastric ulcer patients.PATIENTS AND METHOD:Seventy-three patients with gastric ulcer were prospectively studied. At endoscopy two biopsies from both antrum and body for haematoxylin-eosin staining and one for rapid urease test were obtained. Likewise, serology and 13C-urea breath test were carried out. Fifty-six H. pylori infected patients were monitored after giving an eradication therapy with omeprazole, clarithromycin and amoxicillin. A first control endoscopy was performed immediately after completing treatment to confirm ulcer healing. A second control endoscopy (with histologic study) and a breath test were performed one month after completing therapy (eradication was defined as the absence of H. pylori by both methods). Finally, an endoscopy was repeated at 6 and 12 months to study ulcer recurrences.RESULTS:Mean age was 54 +/- 13 years (69% males). Cumulative ulcer recurrence rate for 12 months, respectively for patients with eradication success and failure, was 2.3% (95% CI, 0-12%) and 70% (34-93%) (chi 2: 23.9; p < 0.0001). Comparison between Kaplan-Meier curves for ulcer recurrence depending on H. pylori eradication showed significant differences (log-rank test; chi 2: 33.8; p < 0.0001). A patient successfully treated underwent ulcer recurrence while receiving treatment with acetylsalicylic acid, without recurrence of the infection.CONCLUSIONS:H. pylori eradication is associated with a dramatic reduction on the recurrence of gastric ulcer, with a cumulative recurrence rate during 12 months of only 2.3%, which suggests that definitive cure of gastric ulcer disease is possible by means of microorganism eradication.

Our aim was to determine concordance between 13C-urea breath test and serology in detecting Helicobacter pylori and to study their potential use for monitoring eradication in patients with gastric ulcer. We prospectively studied 73 gastric ulcer patients. On endoscopy, biopsies were taken for hematoxylineosin staining and rapid urease testing. Blood samples were drawn for immunoglobulin G antibody determination by enzyme-linked immunosorbent assay (ELISA). A 13C-urea breath test was performed as well. Histology, serology, and urea breath tests were all repeated 1, 6, and 12 months after therapy completion in 56 infected patients. A proportion of positive agreement between serology and breath test results as high as 0.95 was found. McNemar statistic was 3 (p = 0.08), whereas kappa statistic was 0.83 (p < 0.0001). At month 6, significant differences in patients successfully treated relative to baseline serologic values were observed (chi2 = 11.7; p < 0.001). The area under the receiver operating characteristic (ROC) curve for diagnostic efficiency was 0.76, sensitivity was 74%, and specificity was 90% (for H. pylori eradication) when the fall of at least one category in serologic levels was considered as cut-off point. No further decreases in serologic levels were noted over the next 6 months, and 48.8% of patients remained seropositive 1 year after completion of successful treatment. A high concordance between serology and 13C-urea breath test results is observed when the two procedures are used for H. pylori infection diagnosis in patients with gastric ulcer. Also, serology can be successfully used for monitoring H. pylori eradication 6 months after therapy completion.