Santa Margherita di Belice, Italy
Santa Margherita di Belice, Italy

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Riccioni M.E.,Catholic University of Rome | Urgesi R.,Gastroenterology and Digestive Endoscopy Unit | Cianci R.,Catholic University of Rome | Rizzo G.,Catholic University of Rome | And 3 more authors.
World Journal of Gastroenterology | Year: 2013

AIM: To assess the rate of recurrent bleeding of the small bowel in patients with obscure bleeding already undergone capsule endoscopy (CE) with negative results. METHODS: We reviewed the medical records related to 696 consecutive CE performed from December 2002 to January 2011, focusing our attention on patients with recurrence of obscure bleeding and negative CE. Evaluating the patient follow-up, we analyzed the recurrence rate of obscure bleeding in patient with a negative CE. Actuarial rates of rebleeding during follow-up were calculated, and factors associated with rebleeding were assessed through an univariate and multivariate analysis. A P value of less than 0.05 was regarded as statistically significant. The sensitivity, specificity, and positive and negative predictive values (PPV and NPV) of negative CE were calculated. RESULTS: Two hundred and seven out of 696 (29.7%) CE studies resulted negative in patient with obscure/overt gastrointestinal bleeding. Overall, 489 CE (70.2%) were positive studies. The median follow-up was 24 mo (range 12-36 mo). During follow-up, recurrence of obscure bleeding was observed only in 34 out of 207 negative CE patients (16.4%); 26 out of 34 with obscure overt bleeding and 8 out of 34 with obscure occult bleeding. The younger age (< 65 years) and the onset of bleeding such as melena are independent risk factors of rebleeding after a negative CE (OR = 2.6703, 95%CI: 1.1651-6.1202, P = 0.0203; OR 4.7718, 95%CI: 1.9739-11.5350, P = 0.0005). The rebleeding rate (CE+ vs CE-) was 16.4% vs 45.1% (χ2 test, P = 0.00001). The sensitivity, specificity, and PPV and NPV were 93.8%, 100%, 100%, 80.1%, respectively. CONCLUSION: Patients with obscure gastrointestinal bleeding and negative CE had a significantly lower rebleeding rate, and further invasive investigations can be deferred. © 2013 Baishideng. All rights reserved.


Barbara G.,University of Bologna | Cremon C.,University of Bologna | Annese V.,University of Florence | Basilisco G.,Gastroenterology Unit | And 18 more authors.
Gut | Year: 2016

Objective: Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. Design: We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. Results: A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Conclusions: Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. Trial registration number: ClincialTrials.gov number, NCT00626288. © 2016, BMJ. All rights reserved.


Iacopini F.,Gastroenterology and Digestive Endoscopy Unit | Bella A.,Instituto Superiore Of Sanita | Costamagna G.,European University at Rome | Gotoda T.,Tokyo Medical University | And 5 more authors.
Gastrointestinal Endoscopy | Year: 2012

Background: Endoscopic submucosal dissection (ESD) has revolutionized the resection of GI superficial neoplasms, but adoption in Western countries is significantly delayed. Objective: To evaluate a stepwise colorectal endoscopic submucosal dissection (ESD) learning and operative training protocol. Design: Prospective study in the Western setting. Setting: This study took place in a nonacademic hospital with one endoscopist expert in therapeutic endoscopy but novice in ESD. Patients: Indications for ESD were superficial neoplasms 20 mm and larger without ulcerations or fibrosis. Intervention: Training consisted of 5 unsupervised ESDs on isolated stomach, an observation period at an ESD expert Japanese center, 1 supervised ESD on isolated stomach, and retraining on 1 rectal ESD under supervision. The operative training on patients was performed without supervision moving from the rectum to the colon according to the competence achieved. Main Outcome Measurements: Competence was defined as an 80% en bloc resection rate plus a statistically significant reduction in operating time per square centimeter. Learning curves were calculated based on consecutive blocks of 5 procedures. Results: From February 2009 to February 2012, 30 rectal and 30 colonic ESDs were performed. The rectal ESD learning curve showed that the en bloc resection rate was 80% after 5 procedures (P = not significant); the operating time per square centimeter significantly decreased after 20 procedures (P =.0079); perforation occurred in 1 patient. The colonic ESD learning curve showed that the en bloc resection rate was 80% after 20 procedures (P = not significant); the operating time per square centimeter significantly decreased after 20 procedures (P =.031); perforations occurred in 2 patients. Limitations: Single-center design. Conclusions: A minimal intensive training seems sufficient for endoscopists expert in therapeutic procedures to take up ESD in a not overly arduous incremental method with separate and sequential learning curves for the rectum and colon. © 2012 American Society for Gastrointestinal Endoscopy.


Repici A.,IRCCS Instituto Clinico Humanitas | Cestari R.,Presidio | Annese V.,Gastroenterology Unit | Biscaglia G.,IRCCS Casa Sollievo della Sofferenza | And 7 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2012

Background Low-volume bowel preparations with polyethylene glycol (PEG) have been shown to provide an equivalent cleansing with improved tolerability as compared with standard PEG bowel preparation for colonoscopy. A new iso-osmotic sulphate-free formulation of PEG-Citrate-Simethicone (PEG-CS) in combination with bisacodyl has been recently developed. Aim To compare the quality of bowel cleansing with PEG-CS with bisacodyl vs. PEG-Ascorbate (PEG-ASC) in adult out-patients undergoing colonoscopy. Methods Randomised, observer-blind, parallel group study in adult out-patients undergoing colonoscopy in five Italian centres. Both preparations were taken the evening before the procedure. Subjects were instructed to take 2-4 tablets of 5 mg bisacodyl at 16:00 hours and 2 L of PEG-CS at 20:00 hours or 2 L of PEG-ASC plus 1 L of additional water the day before colonoscopy. Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale (≥6 scores were considered as 'clinical success'), and mucosal visibility according to a 3-point scale. Tolerability, acceptability and compliance were also evaluated. Results Four hundred and eight patients were randomly allocated to PEG-CS and bisacodyl (n = 204, male patient 48%, mean age 59.1 years) or PEG-ASC (n = 204, male patient 51%, age 59.4 years). In the planned per-protocol analysis, the rate of successful preparation was 79.1% following PEG-CS with bisacodyl, and 70% following PEG-ASC (P < 0.05). Mucosal visibility was evaluated as optimal in 56.1% in the PEG-CS and bisacodyl and 46.3% in the PEG-ASC group (P < 0.05). There were no serious adverse events (AE) in each of the two experimental groups. Two subjects in the PEG-ASC group discontinued the study because of AE. Conclusions Polyethylene glycol-Citrate-Simethicone in combination with bisacodyl was more effective for bowel cleansing than PEG-ASC for out-patient colonoscopy. Tolerability, safety, acceptability and compliance of the two low-volume bowel preparations were similar. © 2012 Blackwell Publishing Ltd.


Tontini G.E.,Friedrich - Alexander - University, Erlangen - Nuremberg | Tontini G.E.,Gastroenterology and Digestive Endoscopy Unit | Bisschops R.,University Hospital Gasthuisberg | Neumann H.,Friedrich - Alexander - University, Erlangen - Nuremberg
Expert Review of Gastroenterology and Hepatology | Year: 2014

Endoscopy plays a pivotal role for diagnosis and assessment of disease activity and extent in patients with inflammatory bowel diseases. International guidelines recommend the use of endoscopic scoring systems for evaluation of the prognosis and efficacy of medical treatments. Ideal scoring systems are easy to use, reproducible, reliable, responsive to changes, and validated in different clinical settings in order to guide therapeutic strategies. However, currently available endoscopic scoring systems often appear as complex for routine endoscopy and suffer from insufficient interobserver agreement and lack of formal validation which often limit their use in clinical trials. Here, we describe the role of endoscopic scoring systems in inflammatory bowel diseases focusing on pros and cons in the era of advanced endoscopic imaging and mucosal healing. © 2014 Informa UK, Ltd.


Tontini G.E.,Gastroenterology and Digestive Endoscopy Unit | Rath T.,Friedrich - Alexander - University, Erlangen - Nuremberg | Neumann H.,Friedrich - Alexander - University, Erlangen - Nuremberg
World Journal of Gastroenterology | Year: 2016

Gastrointestinal luminal endoscopy is of paramount importance for diagnosis, monitoring and dysplasia surveillance in patients with both, Crohn's disease and ulcerative colitis. Moreover, with the recent recognition that mucosal healing is directly linked to the clinical outcome of patients with inflammatory bowel disorders, a growing demand exists for the precise, timely and detailed endoscopic assessment of superficial mucosal layer. Further, the novel field of molecular imaging has tremendously expanded the clinical utility and applications of modern endoscopy, now encompassing not only diagnosis, surveillance, and treatment but also the prediction of individual therapeutic responses. Within this review, we describe how novel endoscopic approaches and advanced endoscopic imaging methods such as high definition and high magnification endoscopy, dye-based and dye-less chromoendoscopy, confocal laser endomicroscopy, endocytoscopy and molecular imaging now allow for the precise and ultrastructural assessment of mucosal inflammation and describe the potential of these techniques for dysplasia detection.


Tontini G.E.,Friedrich - Alexander - University, Erlangen - Nuremberg | Vecchi M.,Gastroenterology and Digestive Endoscopy Unit | Neurath M.F.,Friedrich - Alexander - University, Erlangen - Nuremberg | Neumann H.,Friedrich - Alexander - University, Erlangen - Nuremberg | Neumann H.,University of Milan
Alimentary Pharmacology and Therapeutics | Year: 2013

Background Recent innovations in gastrointestinal endoscopy have changed our traditional approach to diagnosis and therapy in patients with inflammatory bowel diseases (IBD). While traditionally used dye-based chromoendoscopy (DBC) techniques suffer from several limitations that reduce their utility in daily routine practice, newer 'dye-less' chromoendoscopy (DLC) techniques offer a great potential to overcome most of these limitations. Aim To review available optical and digital chromoendoscopy techniques, by critically discussing their potential for diagnostic and surveillance colonoscopy in patients with IBD. Methods A literature search on the use of dye-less and dye-based chromoendoscopy in IBD patients was performed. Results In long-standing IBD, DBC improves detection of dysplasia (diagnostic odds ratio = 17.5, 95% CI = 1.2-247.1) as well as prediction of inflammatory disease activity and extent of disease compared with standard video-colonoscopy. Narrow band imaging (NBI) shows no improvement in dysplasia detection rates compared with white-light endoscopy and DBC (P = 0.6). Moreover, NBI results in a suboptimal differentiation of dysplastic from nondysplastic lesions. No data regarding digital DLC techniques (i.e. FICE, i-scan) for dysplasia detection in IBD are yet available. Both NBI and i-scan are superior to white-light endoscopy in assessing the activity and extent of colorectal IBD. Conclusions Although the potential benefits of newer optical and digital dye-less chromoendoscopy techniques over traditionally used DBC are substantial, only DBC can currently be recommended to improve dysplasia detection in long-standing IBD. In contrast, DLC has the potential to quantify disease activity and mucosal healing in IBD. © 2013 John Wiley & Sons Ltd.


Tontini G.E.,Friedrich - Alexander - University, Erlangen - Nuremberg | Tontini G.E.,Gastroenterology and Digestive Endoscopy Unit | Vecchi M.,Gastroenterology and Digestive Endoscopy Unit | Vecchi M.,University of Milan | And 2 more authors.
Journal of Crohn's and Colitis | Year: 2014

Background: Endoscopy is of pivotal importance in Crohn's disease (CD) patients for diagnosis, surveillance and assessment of disease activity and extent. Device-assisted enteroscopy (DAE) and small-bowel capsule endoscopy (SBCE) have recently changed our endoscopic approach to small-bowel imaging. Furthermore, new advanced endoscopic imaging techniques have been implemented into clinical practice to improve both characterization of mucosal inflammation and detection of dysplastic lesions. Aim: To provide readers with a review about the concept of advanced endoscopic imaging for the diagnosis and characterization of CD. Methods: A literature search on the use of advanced endoscopy techniques in IBD patients was performed. Results: DAE and SBCE allow for deep enteroscopy with high diagnostic yields and low complication's rate but their collocation in the diagnostic algorithm is still not clearly defined. Dye-based chromoendoscopy (DBC) and magnification chromoendoscopy improved dysplasia's detection in long standing colitis and prediction of inflammatory activity and extent. Dye-less chromoendoscopy (DLC) might offer the potential to replace conventional DBC for surveillance. However, both narrow band imaging and i-scan have already shown to significantly improve activity and extent assessment in comparison to white-light endoscopy. Confocal laser endomicroscopy (CLE) can detect more dysplastic lesions in surveillance colonoscopy and predict neoplastic and inflammatory changes with high accuracy compared to histology. Moreover, CLE-based molecular imaging may anticipate the therapeutic responses to biological therapy. Endocytoscopy can identify in vivo inflammatory mucosal cells harboring a new method to assess the mucosal activity. Conclusions: Recent progresses in small-bowel enteroscopy offer several potential benefits to improve both diagnosis and characterization of CD. New advanced endoscopic imaging techniques can improve detection of dysplasia and refine mucosal healing assessment, even looking beyond the morphological parameters revealed by conventional endoscopic imaging. © 2013 European Crohn's and Colitis Organisation.


Tontini G.E.,Gastroenterology and Digestive Endoscopy Unit | Tontini G.E.,Friedrich - Alexander - University, Erlangen - Nuremberg | Vecchi M.,Gastroenterology and Digestive Endoscopy Unit | Vecchi M.,University of Milan | And 4 more authors.
World Journal of Gastroenterology | Year: 2015

Distinction between Crohn's disease of the colonrectum and ulcerative colitis or inflammatory bowel disease (IBD) type unclassified can be of pivotal importance for a tailored clinical management, as each entity often involves specific therapeutic strategies and prognosis. Nonetheless, no gold standard is available and the uncertainty of diagnosis may frequently lead to misclassification or repeated examinations. Hence, we have performed a literature search to address the problem of differential diagnosis in IBD colitis, revised current and emerging diagnostic tools and refined disease classification strategies. Nowadays, the differential diagnosis is an untangled issue, and the proper diagnosis cannot be reached in up to 10% of patients presenting with IBD colitis. This topic is receiving emerging attention, as medical therapies, surgical approaches and leading prognostic outcomes require more and more disease-specific strategies in IBD patients. The optimization of standard diagnostic approaches based on clinical features, biomarkers, radiology, endoscopy and histopathology appears to provide only marginal benefits. Conversely, emerging diagnostic techniques in the field of gastrointestinal endoscopy, molecular pathology, genetics, epigenetics, metabolomics and proteomics have already shown promising results. Novel advanced endoscopic imaging techniques and biomarkers can shed new light for the differential diagnosis of IBD, better reflecting diverse disease behaviors based on specific pathogenic pathways. © The Author(s) 2015.


Pastorelli L.,Case Western Reserve University | Pastorelli L.,University of Milan | Pastorelli L.,Gastroenterology and Digestive Endoscopy Unit | Salvo C.D.,Case Western Reserve University | And 5 more authors.
Frontiers in Immunology | Year: 2013

The gut mucosa is constantly challenged by a bombardment of foreign antigens and environmental microorganisms. As such, the precise regulation of the intestinal barrier allows the maintenance of mucosal immune homeostasis and prevents the onset of uncontrolled inflammation. In support of this concept, emerging evidence points to defects in components of the epithelial barrier as etiologic factors in the pathogenesis of inflammatory bowel diseases (IBDs). In fact, the integrity of the intestinal barrier relies on different elements, including robust innate immune responses, epithelial paracellular permeability, epithelial cell integrity, as well as the production of mucus. The purpose of this review is to systematically evaluate how alterations in the aforementioned epithelial components can lead to the disruption of intestinal immune homeostasis, and subsequent inflammation. In this regard, the wealth of data from mouse models of intestinal inflammation and human genetics are pivotal in understanding pathogenic pathways, for example, that are initiated from the specific loss of function of a single protein leading to the onset of intestinal disease. On the other hand, several recently proposed therapeutic approaches to treat human IBD are targeted at enhancing different elements of gut barrier function, further supporting a primary role of the epithelium in the pathogenesis of chronic intestinal inflammation and emphasizing the importance of maintaining a healthy and effective intestinal barrier. © 2013 Pastorelli, De Salvo, Mercado, Vecchi and Pizarro.

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