Lack of interference between small bowel capsule endoscopy and implantable cardiac defibrillators: an 'in vivo' electrophysiological study.

BACKGROUND: Capsule endoscopy is a widely performed procedure for small bowel investigation. Once swallowed by the patient, the capsule transmits images to an external recorder over a digital radiofrequency communication channel. Potential electromagnetic interferences with implantable cardiac devices have been postulated. Clinical studies on the safety of capsule endoscopy in patients with cardiac defibrillators are lacking. OBJECTIVE: The aim of this study was to assess potential mutual electromagnetic interferences between capsule and defibrillators. METHODS: This study used the Given M2A video capsule system. Ten different types of defibrillators were tested in a clinical setting. Before capsule ingestion, defibrillator electrical therapies were switched off. During capsule endoscopy patients were monitored with cardiac telemetry. At the end of capsule endoscopy the following defibrillator's parameters were analysed: change in device settings; inappropriate shocks; inappropriate anti-tachycardia therapy; inappropriate sensing or pacing; noise detection; device reset; programming changes; permanent electrical damages. Any technical problem related to capsule image transmission was recorded. RESULTS: Neither defibrillator malfunction nor interference in sensing or pacing was recorded; conversely, no capsule malfunction potentially caused by defibrillators was registered. CONCLUSION: Our results suggest that capsule endoscopy can be safely performed in patients with cardiac defibrillators.

Intestinal metaplasia in Barrett's oesophagus: An essential factor to predict the risk of dysplasia and cancer development.

BACKGROUND: To date, there is still uncertainty on the role of specialized intestinal metaplasia in the carcinogenic process of Barrett's oesophagus (BE); this fact seems of importance for planning adequate surveillance programs. AIMS: To predict the risk of progression towards dysplasia/cancer based on typical morphological features by evaluating the importance of intestinal metaplasia in BE patients. METHODS: 647 cases with a histological diagnosis of BE, referred to the Endoscopy Unit of a tertiary centre between 2000 and 2012 were retrospectively identified, and divided into two groups according to the presence/absence of intestinal metaplasia. For each patient, all histological reports performed during a follow-up of 4-8 years were analyzed. RESULTS: Overall, 537 cases (83%) with intestinal metaplasia and 110 cases (17%) without intestinal metaplasia were included. During the follow-up period, none of the patients without intestinal metaplasia developed dysplasia/cancer nor progressed to metaplasia, whereas 72 patients with intestinal metaplasia (13.4%) showed histological progression of the disease. CONCLUSION: The histological identification of intestinal metaplasia seems to be an essential factor for the progression towards dysplasia and cancer in BE patients.

Classification of adults suffering from typical gastroesophageal reflux disease symptoms: contribution of latent class analysis in a European observational study.

BACKGROUND: As illustrated by the Montreal classification, gastroesophageal reflux disease (GERD) is much more than heartburn and patients constitute a heterogeneous group. Understanding if links exist between patients' characteristics and GERD symptoms, and classify subjects based on symptom-profile could help to better understand, diagnose, and treat GERD. The aim of this study was to identify distinct classes of GERD patients according to symptom profiles, using a specific statistical tool: Latent class analysis. METHODS: An observational single-visit study was conducted in 5 European countries in 7700 adults with typical symptoms. A latent class analysis was performed to identify "latent classes" and was applied to 12 indicator symptoms. RESULTS: On 7434 subjects with non-missing indicators, latent class analysis yielded 5 latent classes. Class 1 grouped the highest severity of typical GERD symptoms during day and night, more digestive and non-digestive GERD symptoms, and bad sleep quality. Class 3 represented less frequent and less severe digestive and non-digestive GERD symptoms, and better sleep quality than in class 1. In class 2, only typical GERD symptoms at night occurred. Classes 4 and 5 represented daytime and nighttime regurgitation. In class 4, heartburn was also identified and more atypical digestive symptoms. Multinomial logistic regression showed that country, age, sex, smoking, alcohol use, low-fat diet, waist circumference, recent weight gain (>5 kg), elevated triglycerides, metabolic syndrome, and medical GERD treatment had a significant effect on latent classes. CONCLUSION: Latent class analysis classified GERD patients based on symptom profiles which related to patients' characteristics. Although further studies considering these proposed classes have to be conducted to determine the reproducibility of this classification, this new tool might contribute in better management and follow-up of patients with GERD.

ALK-positive inflammatory myofibroblastic tumor of the abdomen with widespread microscopic multifocality.

Inflammatory myofibroblastic tumor (IMT) is a locally aggressive neoplasm, most frequently occurring in the abdominal cavity as multiple recurrent nodules. We report a case of IMT in a 24-year-old male presenting as multiple nodules involving the omentum, the liver, and the colon. Spindle tumor cells expressed ALK with a cytoplasmic granular distribution, the CLTC-ALK fusion gene was demonstrated by reverse-transcriptase polymerase chain reaction analysis, and break-apart fluorescence in situ hybridization (FISH) probes for the ALK gene showed a pathological pattern (single red signal associated with 1/2 normal fused signals) highly suggestive for combined gene fusion and deletion. To reduce the surgically unresectable liver mass, the patient was treated with crizotinib, and after 4 months of treatment the disease was defined stable according to RECIST criteria. Interestingly, ALK and FISH/FICTION analysis revealed that tumor cells were widely dispersed as multiple microscopic foci or as single cells beneath the omental mesothelium. These findings indicate that IMT multifocality might result either from dissemination from the main tumor mass or development of multiple independent neoplastic foci; furthermore, they underline the need of omentectomy in abdominal IMT to obtain surgical radicality.

Is it possible to clinically differentiate erosive from nonerosive reflux disease patients? A study using an artificial neural networks-assisted algorithm.

BACKGROUND: The use of either symptom questionnaires or artificial neural networks (ANNs) has proven to improve the accuracy in diagnosing gastroesophageal reflux disease (GERD). However, the differentiation between the erosive and nonerosive reflux disease based upon symptoms at presentation still remains inconclusive. AIM: To assess the capability of a combined approach, that is, the use of a novel GERD questionnaire - the QUestionario Italiano Diagnostico (QUID) questionnaire - and of an ANNs-assisted algorithm, to discriminate between nonerosive gastroesophageal reflux disease (NERD) and erosive esophagitis (EE) patients. METHODS: Five hundred and fifty-seven adult outpatients with typical GERD symptoms and 94 asymptomatic adult patients, were submitted to the QUID questionnaire. GERD patients were then submitted to upper gastrointestinal endoscopy to differentiate them between EE and NERD patients. RESULTS: The QUID score resulted significantly (P<0.001) higher in GERD patients versus controls, but it was not statistically significantly different between EE and NERD patients. ANNs assisted diagnosis had greater specificity, sensitivity and accuracy compared with the linear discriminant analysis only to differentiate GERD patients from controls. However, no single technique was able to satisfactorily discriminate between EE and NERD patients. CONCLUSION: Our study suggests that the combination between QUID questionnaire and an ANNs-assisted algorithm is useful only to differentiate GERD patients from healthy individuals but fails to further discriminate erosive from nonerosive patients.

TOPOIIalpha and HER-2/neu overexpression/amplification in Barrett's oesophagus, dysplasia and adenocarcinoma.

AIMS: Topoisomerase IIalpha (TOPOIIalpha) and HER-2/neu are chromosome 17q genes coamplified in various cancers; no data exist for Barrett's oesophagus (BO) and BO adenocarcinoma (ADC). The aim was to investigate gene amplification and protein overexpression of TopoIIalpha and Her-2/neu in non-dysplastic BO, dysplastic BO, Barrett ADC, and chromosome 17 aneusomy. METHODS AND RESULTS: Forty-four patients [18 BO, 13 BO with dysplasia (five low-grade dysplasia, eight high-grade dysplasia) and 13 ADC in BO] were evaluated by immunohistochemistry and fluorescence in situ hybridization (FISH). Genes (HER-2/neu and TOPOIIalpha) and chromosome 17 were evaluated by FISH. Patients with BO, dysplasia and ADC were compared. A significant association was found between TOPOIIalpha protein overexpression and TopoIIalpha gene amplification, chromosome 17 aneusomy, HER-2/neu gene amplification and HER-2 protein overexpression as well as between HER-2 protein and HER-2/neu gene, TopoIIalpha gene and aneusomy for chromosome17, and between the genes TOPOIIalpha and HER-2/neu. Gene amplification (HER-2/neu, TOPOIIalpha), protein overexpression (HER-2/TOPOIIalpha), and chromosome 17 aneusomy were associated with dysplasia or ADC. Most BO patients showed no amplification/overexpression/aneusomy for the above genes, proteins and chromosome, with no differences between dysplasia and ADC. CONCLUSIONS: HER-2/neu and TOPOIIalpha amplification/overexpression might discriminate between BO and dysplasia/ADC. Chromosome 17 aneusomy is associated with dysplasia or ADC in BO.

[GerdQ: tool for the diagnosis and management of gastroesophageal reflux disease in primary care]. / GerdQ: uno strumento per la diagnosi e la gestione della malattia da reflusso gastroesofageo nella medicina generale.

Diagnosis and effective management of gastroesophageal reflux (GERD) need a new approach. The 2009 Montreal Consensus recommended that the clinical diagnosis of GERD should be made on the presence of troublesome symptoms. GerdQ, a patient centered-self assessment questionnaire, is made to assist health care professionals. Also, it is easy to use, no diagnostic test required, for example without previous specialist referral or endoscopy. GerdQ is a well documented questionnaire, developed on the basis of evidence. GerdQ has three potential uses in clinical practice: (1) to diagnose gastroesophagel reflux disease with an accuracy similar to that of the gastroenterological evaluation; (2) to assess the relative impact of the disease on patient's lives and to assist in choice of treatment; (3) to measure response to treatment over the time.

Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED Score and Prospective Comparison with the Rockall Score.

OBJECTIVES: We sought (i) to validate a new prediction rule of mortality (Progetto Nazionale Emorragia Digestiva (PNED) score) on an independent population with non-variceal upper gastrointestinal bleeding (UGIB) and (ii) to compare the accuracy of the Italian PNED score vs. the Rockall score in predicting the risk of death. METHODS: We conducted prospective validation of analysis of consecutive patients with UGIB at 21 hospitals from 2007 to 2008. Outcome measure was 30-day mortality. All the variables used to calculate the Rockall score as well as those identified in the Italian predictive model were considered. Calibration of the model was tested using the chi2 goodness-of-fit and performance characteristics with receiver operating characteristic (ROC) analysis. The area under the ROC curve (AUC) was used to quantify the diagnostic accuracy of the two predictive models. RESULTS: Over a 16-month period, data on 1,360 patients were entered in a national database and analyzed. Peptic ulcer bleeding was recorded in 60.7% of cases. One or more comorbidities were present in 66% of patients. Endoscopic treatment was delivered in all high-risk patients followed by high-dose intravenous proton pump inhibitor in 95% of them. Sixty-six patients died (mortality 4.85%; 3.54-5.75). The PNED score showed a high discriminant capability and was significantly superior to the Rockall score in predicting the risk of death (AUC 0.81 (0.72-0.90) vs. 0.66 (0.60-0.72), P<0.000). Positive likelihood ratio for mortality in patients with a PNED risk score >8 was 16.05. CONCLUSIONS: The Italian 10-point score for the prediction of death was successfully validated in this independent population of patients with non-variceal gastrointestinal bleeding. The PNED score is accurate and superior to the Rockall score. Further external validation at the international level is needed.

HER-2 overexpression/amplification in Barrett's oesophagus predicts early transition from dysplasia to adenocarcinoma: a clinico-pathologic study.

Barrett's oesophagus (BO) is the primary precursor lesion for oesophageal adenocarcinoma (ADC). The natural history of metaplasia-dysplasia-carcinoma sequence remains largely unknown. HER2/neu oncogene results overexpressed/amplified in preneoplastic lesions and in ADC of the oesophagus and it has been associated with poor prognosis. Our aim was to evaluate the role of HER2 overexpression/amplification in predicting the conversion from precursor lesions to ADC. We retrospectively evaluated by univariate analysis of single variables clinical records and histological specimens of 21 patients with a confirmed diagnosis of BO and/or oesophageal dysplasia. Clinical variables included age, gender, alcohol and smoking intake, presence of symptoms (pyrosis, disphagia) and endoscopic features (length). HER2 status was studied by immunohistochemistry and fluorescence in situ hybridization (FISH) on paraffin-embedded tissue. The end-points were the occurrence of progression and the time-to-progression (TTP) from the initial histologic lesion to the worst pathological pattern. Median age at diagnosis was 63 years (range 37-84). BO median length was 4.5 cm. Progression occurred in 11 of 21 patients and median TTP was 24 months. HER2 was overexpressed/amplified in 8 of 21 (38%) patients. HER2 overexpression/ amplification and the presence of dysplasia were statistically associated with progression (P= 0.038). This study provides evidence for a possible role of HER2 in the transition from dysplasia to ADC of the oesophagus. This fact could help in identifying patients at high risk of malignant transformation.

Immunocytochemical assessment of p53 protein to detect malignancy in increased cell-yield brush cytology from the biliopancreatic tree.

BACKGROUND: Malignancies arising from the biliopancreatic tree are often diagnostic challenges for the gastroenterologist and the pathologist, especially when strictures without masses are present. AIM: To evaluate the diagnostic yield of p53 immunocytology for the detection of malignancies in material obtained by biliopancreatic tree brushing by means of an increased cell-yield procedure. PATIENTS AND METHODS: Cytologic specimens obtained from biliary and pancreatic tree brushing in 24 patients with biliary strictures suspected for malignancy were assessed by conventional Papanicolau staining and p53 immunocytochemistry. RESULTS: Papanicolau staining detected 67% and p53 87% of the malignancies in the study group. p53 immunocytology displayed excellent sensitivity, specificity, and diagnostic accuracy. CONCLUSIONS: p53 immunocytology may represent a useful diagnostic tool in the detection of malignancies from biliary and pancreatic tree brushing, especially when using an increasing cell-yield procedure.

The role of nonacid reflux in NERD: lessons learned from impedance-pH monitoring in 150 patients off therapy.

INTRODUCTION: Nonerosive reflux disease (NERD) is the most common form of gastroesophageal reflux disease. While the role of acid reflux has been established, the relevance of nonacid reflux in generating symptoms in NERD is unknown. AIM: To evaluate the diagnostic utility of impedance-pH monitoring in NERD patients. METHODS: Patients with typical reflux symptoms (heartburn and/or regurgitation) and normal endoscopy (NERD) underwent a combined impedance-pH monitoring off proton pump inhibitor (PPI) therapy. Previously investigated 48 healthy volunteers served as controls. Distal esophageal acid exposure (% time pH < 4), number of acid and nonacid reflux episodes, 2-min window symptom index (SI; positive if > or = 50%), and symptom association probability (SAP; positive if > or = 95%) were calculated. RESULTS: Between June 2004 and June 2007, 150 NERD patients (82 women, mean age 48 yr, range 18-78 yr) reported symptoms during the impedance-pH monitoring. NERD patients had more reflux episodes (median [25th-75th percentile]) compared with healthy volunteers (total: 46 [26-65] vs 32 [18-43], P < 0.05; acid: 29 [14-43] vs 17 [8.5-31.0], P < 0.05; and nonacid: 20 [15-27] vs 18 [13.5-26.0], P = NS). Sixty-three (42%) patients had abnormal % time pH < 4. Among 87 patients with normal % time pH < 4., 22 (15%) had a positive SAP for acid, 19 (12%) for nonacid reflux, and 7 (5%) for both. Classifying patients with symptomatic nonacid reflux as having a hypersensitive esophagus reduced the number of patients with functional heartburn from 65 (43%) to 39 (26%). CONCLUSION: Monitoring for nonacid reflux in NERD patients reduces the proportion of patients classified as having "functional heartburn." Studies assessing the clinical implications of these findings are warranted.

Predictive factors of mortality from nonvariceal upper gastrointestinal hemorrhage: a multicenter study.

OBJECTIVES: From an Italian Registry of patients with upper gastrointestinal hemorrhage (UGIH), we assessed the clinical outcomes and explored the roles of clinical, endoscopic, and therapeutic factors on 30-day mortality in a real life setting. METHODS: Prospective analysis of consecutive patients endoscoped for UGIH at 23 community and tertiary care institutions from 2003 to 2004. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression analysis identified predictors of mortality. RESULTS: One thousand and twenty patients were included. A total of 46 patients died for an overall 4.5% mortality rate. In all, 85% of deaths were associated with one or more major comorbidity. Sixteen of 46 patients (35%) died within the first 24 h of the onset of bleeding. Of these, eight had been categorized as ASA class 1 or 2 and none of them was operated upon, despite a failure of endoscopic intention to treatment in four. Regression analysis showed advanced age, presence of severe comorbidity, low hemoglobin levels at presentation, and worsening health status as the only independent predictors of 30-day mortality (P < 0.001). The acute use of a PPI exerted a protective effect (OR 0.23, 95% CI 0.09-0.73). Recurrent bleeding was low (3.2%). Rebleeders accounted for only 11% of the total patients deceased (OR 3.27, 95% CI 1.5-11.2). CONCLUSIONS: These results indicate that 30-day mortality for nonvariceal bleeding is low. Deaths occurred predominantly in elderly patients with severe comorbidities or those with failure of endoscopic intention to treatment.

The pathology of gastric cardia: a prospective, endoscopic, and morphologic study.

"Carditis" (inflammation of the gastric cardiac mucosa) may be associated with gastroesophageal reflux disease (GERD), whereas other studies argue that Helicobacter pylori could play a significant role in the chronic cardiac damage. We examined prospectively histologic features of gastric cardia, esophagitis, and H. pylori status in 204 consecutive subjects with GERD symptoms (57.3% male, 42.7% female mean age 49.2 y) undergoing upper gastrointestinal endoscopy with multiple biopsies in the distal esophagus, cardiac region, and stomach. These were assessed for esophagitis landmarks [Ismail Beigi grading (g0-3)], gastritis, and H. pylori infection (Sydney classification). The average symptom duration was 10.8 months. Endoscopy showed no erosive disease in 54.5% patients, grade "A" esophagitis in 37.6%, "B" in 8%, and "C" in 1 case. Histologic examination disclosed g0 in 8.3% patients, g1 in 78.4%, g2 in 12.8%, and g3 in 1; analysis of the cardia showed oxyntic mucosa in 27.9% patients and chronic cardiac mucosa inflammation in 72.1%. Carditis was significantly related to macroscopic esophagitis (P=0.044) and heartburn score (P=0.001). H. pylori cardiac infection was present in 27.4% cases (73.2% associated with cardiac mucosa). Gastric H. pylori infection was demonstrated in 35% patients. H. pylori in the cardiac region was associated with gastric H. pylori infection (P=0.001) and with paucity of GERD symptoms (P=0.05). A good correlation between carditis and GERD, concerning symptoms and macroscopic esophagitis was found in this study. H. pylori-related carditis is likely to be differently compared with the GERD-related type.

Fluorescence in situ hybridization to evaluate dysplasia in Barrett's esophagus: a pilot study.

BACKGROUND: Histological disagreement is frequent in the diagnosis and grading of dysplasia in Barrett's esophagus (BE). AIMS: To identify selective markers for dysplasia in BE and to improve the differentiation between low-grade dysplasia (LGD) and high-grade dysplasia (HGD). METHODS: Eight BE esophageal mucosectomies (7 males) were analyzed by conventional histology and immunohistochemistry for p53 and Fluorescence In situ Hybridization (FISH) for chromosomes X, Y, 4, 8, 17, 18. The female mucosectomy was considered as a control for the XY probe. RESULTS: p53 confirmed multifocal dysplasia in all cases. All patients displayed increased aneusomy for chromosomes 4, 8, 17 and 18 along the sequence of cancer progression. There was also a trend for chromosome 8 to be below the FISH cutoff; 50% of cases showed aneusomy for chromosome 18 in areas with differing grades of dysplasia. Aneusomy was increased for chromosomes 4 and 17, to a similar extent in LGD and HGD. In male specimens, the presence of chromosome Y was revealed in Barrett's mucosa and LGD, but not in HGD and intramucosal carcinoma. CONCLUSIONS: FISH in BE may be useful diagnostic to confirm the diagnosis of HGD. Loss of chromosome Y might be a selective marker of HGD in male patients.

Her-2/neu in barrett esophagus: a comparative study between histology, immunohistochemistry, and fluorescence in situ hybridization.

Her-2/neu is a protooncogene frequently overexpressed in breast cancer, recently found to be also overexpressed in carcinoma arising on Barrett esophagus (BE). Immunohistochemistry and fluorescence in situ hybridization (FISH) are conventionally used for Her-2 testing in carcinomas, but a single assay is not yet accepted as a "gold standard" in BE. To evaluate the correlation between histopathology variables and gene expression/amplification in the sequence BE-low grade dysplasia-high grade dysplasia-adenocarcinoma, fifty esophageal specimens from patients with a diagnosis of BE (21 BE, 4 low-grade dysplasia, 12 high-grade dysplasia, and 13 adenocarcinomas) were evaluated. Histopathologic evaluation was carried out using hematoxylin and eosin staining. Paraffin-embedded tissues were investigated for Her-2 by immunohistochemistry (HercepTest) and FISH. HercepTest was scored 0, 1+, 2+, and 3+ depending on the percentage (cut off 10%) of membrane staining, whereas gene assessment evaluated by FISH was based on the ratio between Her-2/neu and the 17 chromosome copy number. There was a positive correlation between gene amplification and protein overexpression. No case with HercepTest scoring 0 or 1+ displayed gene amplification, but this was present in 20% of cases scoring 2+ and in all cases scoring 3+. Her-2/neu amplification or overexpression was never observed in BE. Gene amplification and overexpression was observed in more than 50% of dysplasias and adenocarcinomas. Her-2/neu amplification/overexpression might be considered as a marker of progression from BE to dysplasia. FISH may represent a useful diagnostic tool to integrate the result of HercepTest for selecting patients for more targeted therapeutic approaches.

Artificial neural networks are able to recognize gastro-oesophageal reflux disease patients solely on the basis of clinical data.

BACKGROUND: Artificial neural networks (ANN) are modelling mechanisms that are highly flexible and adaptive to solve the non-linearity inherent in the relationship between symptoms and underlying pathology. OBJECTIVES: To assess the efficacy of ANN in achieving a diagnosis of gastro-oesophageal reflux disease (GORD) using oesophagoscopy or pH-metry as a diagnostic gold standard and discriminant analysis as a statistical comparator technique in a group of patients with typical GORD symptoms and with or without GORD objective findings (e.g. a positive oesophagoscopy or a pathological oesophageal pH-metry). METHODS: The sample of 159 cases (88 men, 71 women) presenting with typical symptoms of GORD, were subdivided on the basis of endoscopy and pH-metry results into two groups: GORD patients with or without oesophagitis, group 1 (N=103), and pH and endoscopy-negative patients in whom both examinations were negative, group 2 (N=56). A total of 101 different independent variables were collected: demographic information, medical history, generic health state and lifestyle, intensity and frequency of typical and atypical symptoms based on the Italian version of the Gastroesophageal Reflux Questionnaire (Mayo Clinic). The diagnosis was used as a dependent variable. Different ANN models were assessed. RESULTS: Specific evolutionary algorithms selected 45 independent variables, concerning clinical and demographic features, as predictors of the diagnosis. The highest predictive performance was achieved by a 'back propagation' ANN, which was consistently 100% accurate in identifying the correct diagnosis compared with 78% obtained by traditional discriminant analysis. CONCLUSION: On the basis of this preliminary work, the use of ANN seems to be a promising approach for predicting diagnosis without the need for invasive diagnostic methods in patients suffering from GORD symptoms.

Oesophageal manometry in early and definite systemic sclerosis.

The objective of this study was to evaluate the oesophageal dysfunction in patients with "early" systemic sclerosis (SSc), as defined by LeRoy and Medsger, to compare it with that of patients with definite SSc, and to correlate it with other features of the disease. Oesophageal manometry results were retrospectively evaluated in 181 patients classified by the 2001 LeRoy and Medsger criteria and the 1980 American College of Rheumatology (ACR) criteria: group 1: limited SSc: Raynaud's phenomenon plus specific nailfold capillaroscopy abnormalities and/or autoantibodies; group 2: limited cutaneous SSc not satisfying the ACR criteria (lcSSc ACR-); group 3: lcSSc ACR+; group 4: diffuse cutaneous SSc. Peristaltic abnormalities in the oesophageal body were present in 73 of 125 patients with SSc ACR+ (groups 3 and 4) compared with 13 of 56 with SSc ACR- (groups 1 and 2) (p < 0.0001). They were more severe in patients with more advanced disease (1 vs 2; 1 vs 3; 1 vs 4; 2 vs 4; p < 0.05) and in patients anti-Scl-70+ than in patients anticentromere positive (p = 0.02). Abnormalities of the lower oesophageal sphincter (LES) were present in 35 of 125 patients with SSc ACR+ and 11 of 56 with SSc ACR- (not statistically different). They were correlated with forced vital capacity (FVC) (LES pressure: p = 0.0005; LES length: p = 0.0004). Abnormalities of the oesophageal body and of the LES were found in 21 and 16% of 46 patients without oesophageal symptoms. Oesophageal manometry can detect abnormalities in a sizeable proportion of patients with "early SSc" not fulfilling the ACR criteria, including asymptomatic patients. The correlation between LES abnormalities and FVC suggests a possible causal relationship between these disease manifestations.

Endoscopic mucosal resection for high-grade dysplasia and intramucosal carcinoma in Barrett's esophagus: an Italian experience.

AIM: To evaluate endoscopic mucosal resection (EMR) in patients with high-grade dysplasia (HGD) and/or intramucosal cancer (IMC) in Barrett's esophagus (BE). METHODS: Between June 2000 and December 2003, 39 consecutive patients with HGD (35) and/or IMC (4) underwent EMR. BE >30 mm was present in 27 patients. In three patients with short segment BE (25.0%), HGD was detected in a normal appearing BE. Lesions had a mean diameter of 14.8+/-10.3 mm. Mucosal resection was carried out using the cap method. RESULTS: The average size of resections was 19.7+/-9.4 x 14.6+/-8.2 mm. Histopathologic assessment post-resection revealed 5 low-grade dysplasia (LGD) (12.8%), 27 HGD (69.2%), 2 IMC (5.1%), and 5 SMC (-12.8%). EMR changed the pre-treatment diagnosis in 10 patients (25.6%). Three patients with SMC underwent surgery. Histology of the surgical specimen revealed 1 T0N0 and 2 T1N0 lesions. The remaining two patients were cancer free at 32.5 and 45.6 mo, respectively. A metachronous lesion was detected after 25 mo in one patient with HGD. Intra-procedural bleeding, controlled at endoscopy, occurred in four patients (10.3%). After a median follow-up of 34.9 mo, all patients remained in remission. CONCLUSION: In the medium term, EMR is effective and safe to treat HGD and/or IMC within BE and is a valuable staging method. It could become an alternative to surgery.

Training with a computer-based simulator achieves basic manual skills required for upper endoscopy: a randomized controlled trial.

BACKGROUND: Changes in medical practice have constrained the time available for education and the availability of patients for training. Computer-based simulators have been devised that can be used to achieve manual skills without patient contact. This study prospectively compared, in a clinical setting, the efficacy of a computer-based simulator for training in upper endoscopy. METHODS: Twenty-two fellows with no experience in endoscopy were randomly assigned to two groups: one group underwent 10 hours of preclinical training with a computer-based simulator, and the other did not. Each trainee performed upper endoscopy in 19 or 20 patients. Performance parameters evaluated included the following: esophageal intubation, procedure duration and completeness, and request for assistance. The performance of the trainees also was evaluated by the endoscopy instructor. RESULTS: A total of 420 upper endoscopies were performed; the computer pretrained group performed 212 and the non-pretrained group, 208. The pretrained group performed more complete procedures (87.8% vs. 70.0%; p < 0.0001), required less assistance (41.3% vs. 97.9%; p < 0.0001), and the instructor assessed performance as "positive" more often for this group (86.8% vs. 56.7%; p < 0.0001). The length of procedures was comparable for the two groups. CONCLUSIONS: The computer-based simulator is effective in providing novice trainees with the skills needed for identification of anatomical landmarks and basic endoscopic maneuvers, and in reducing the need for assistance by instructors.