Upper Gastrointestinal Endoscopy Quality in Italy: A Nationwide Study.

BACKGROUND AND AIMS: International guidelines advise improving esophagogastroduodenoscopy (EGD) quality in Western countries, where gastric cancer is still diagnosed in advanced stages. This nationwide study investigated some indicators for the quality of EGD performed in endoscopic centers in Italy. METHODS: Clinical, endoscopic, and procedural data of consecutive EGDs performed in one month in the participating centers were reviewed and collected in a specific database. Some quality indicators before and during endoscopic procedures were evaluated. RESULTS: A total of 3,219 EGDs performed by 172 endoscopists in 28 centers were reviewed. Data found that some relevant information (family history for GI cancer, smoking habit, use of proton pump inhibitors) were not collected before endoscopy in 58.5-80.7% of patients. Pre-endoscopic preparation for gastric cleaning was routinely performed in only 2 (7.1%) centers. Regarding the procedure, sedation was not performed in 17.6% of patients, and virtual chromoendoscopy was frequently (>75%) used in only one (3.6%) center. An adequate sampling of the gastric mucosa (i.e., antral and gastric body specimens) was heterogeneously performed, and it was routinely performed only by 23% of endoscopists, and in 14.3% centers. CONCLUSIONS: Our analysis showed that the quality of EGD performed in clinical practice in Italy deserves to be urgently improved in different aspects.

Gastrointestinal manifestations of SARS-CoV-2 infection in an Italian population of hospitalized patients.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus enters the cells via angiotensin-converting enzyme 2 receptor; therefore, tissues expressing this receptor are potential targets for infection. Although many studies have observed gastrointestinal (GI) symptoms in coronavirus disease 2019 (COVID-19) patients, prevalence and clinical impact are still uncertain due to the heterogeneity of reports and obstacles to generalization. Methods: In this cross-sectional study, we included symptomatic patients requiring hospital admission, with a confirmed diagnosis of COVID-19 by nasopharyngeal polymerase chain reaction test, between 18 March and 30 May 2020. Demographic data, symptoms at onset, vital signs, and laboratory tests at admission were recorded. Results: In all, 300 patients were included (57%M, 43%F). GI symptoms were mainly diarrhea (13%), anorexia (4.3%), vomiting (3%), and abdominal pain (2.3%). Overall, males were younger (68 years versus 76 years; p = 0.01); patients with GI manifestations at disease onset required significantly faster hospital admission and showed larger GI complication rates. GI symptoms were associated with abnormal high aspartate aminotransferase and alanine aminotransferase serum titers, especially in male patients. Conclusion: Our study on an Italian population during the outbreak of the COVID-19 pandemic shows that GI symptoms are part of the spectrum of the SARS-CoV-2 infection and could be the only manifestations at disease onset. Although patients with GI symptoms were associated with faster hospital admission and liver involvement, prognosis was not affected.

Circulating Extracellular Vesicles Are Increased in Newly Diagnosed Celiac Disease Patients.

Extracellular vesicles (EVs) are a class of circulating entities that are involved in intercellular crosstalk mechanisms, participating in homeostasis maintenance, and diseases. Celiac disease is a gluten-triggered immune-mediated disorder, characterized by the inflammatory insult of the enteric mucosa following local lymphocytic infiltration, resulting in villous atrophy. The goal of this research was the assessment and characterization of circulating EVs in celiac disease patients, as well as in patients already on an adequate gluten-free regimen (GFD). For this purpose, a novel and validated technique based on polychromatic flow cytometry that allowed the identification and enumeration of different EV sub-phenotypes was applied. The analysis evidenced that the total, annexin V+, leukocyte (CD45+), and platelet (CD41a+) EV counts were significantly higher in both newly diagnosed celiac disease patients and patients under GFD compared with the healthy controls. Endothelial-derived (CD31+) and epithelial-derived (EpCAM+) EV counts were significantly lower in subjects under gluten exclusion than in celiac disease patients, although EpCAM+ EVs maintained higher counts than healthy subjects. The numbers of EpCAM+ EVs were a statistically significant predictor of intraepithelial leukocytes (IEL). These data demonstrate that EVs could represent novel and potentially powerful disease-specific biomarkers in the context of celiac disease.

Accreditation program for gastrointestinal endoscopes reprocessing in Italy: An on-site survey.

Background and study aims Endoscope reprocessing has been associated with a variable failure rate. Our aim was to present an overview on current practices for reprocessing in Italian facilities and discuss the principle critical points. Methods In 2014 the Italian Society for Digestive Diseases implemented an accreditation program in collaboration with an independent organization for certification and with the Italian Association for Endoscopy Technical Operators. During a 1-day site visit of the endoscopy center, two endoscopists, one nurse, and the representative of the certification body evaluated the endoscope reprocessing. Results As of July 1, 2020, 28 endoscopy centers had been accredited. Ten centers are completing the measures to correct deficiencies found at the visit. Three centers withdrew from the program. The accreditation program has found variations between the various centers, confirming the poor compliance with guidelines. Major deviations from the standards, established by the model before the site visit according to national and international guidelines, concerned instrument cleaning (44.7 % of the centers), instrument storage (23.7 %), and microbiological tests (31.6 %). Conclusions Our overview demonstrated the lack of many reprocessing phases, which are important to prevent endoscopy-associated infections. Accreditation can achieve a transformation in quality and safety of reprocessing with the Italian centrally-led approach.

Accreditation of digestive endoscopy services: a method of quality assuring?

INTRODUCTION: Accreditation is one method of assuring quality, but the evidence base in support of service accreditation is mixed. More recent experiences indicate that accreditation may accelerate improvements. AREAS COVERED: Our aim is focused on endoscopy service accreditation and we conducted a literature search using Medline (via Pubmed) and the Cochrane Center Register of Controlled Trials up to January 2020. EXPERT OPINION: Worldwide numerous centers fail to meet important quality indicators as suggested by international guidelines. Accreditation can provide means for detecting many problems and correcting them by implementing agreed standards.

The Italian Society for Digestive Endoscopy (SIED) accreditation and quality improving project based on international standards.

Background and study aims Accreditation of endoscopy services, using valid quality indicators, may address failures to comply with quality standards between endoscopy services. The aim of this work was to present the Italian Society for Digestive Endoscopy (SIED) accreditation model and its effectiveness. Methods A team of eight endoscopists identified quality indicators derived from international guidelines and assessed them in each center voluntarily requesting accreditation. During a 1-day site visit, two expert endoscopists, the representative of the independent and international administrative certification body and a professional nurse evaluated the endoscopy center, by direct observation of the endoscopy team and examination of the medical records Results In all centers we noted shortcomings in instrument reprocessing. In 30 of 40 centers (75 %) the information in the nursing charts was incomplete. Sampling for Helicobacter pylori had not been done in 12 of 40 centers (30 %). In six of 40 centers (15 %) the adenoma detection rate for each endoscopist had not been evaluated. Post-polypectomy intervals were inappropriate in 12 of 40 centers (30 %). We noted a statistically significant difference ( P  < 0.001) between the answers to the SIED checklist of indicators submitted to the inspection team for accreditation before the site visit and the situation found for colonoscopy on site. As of June 30, 2018, 18 endoscopy centers had been accredited and 10 centers had not yet being accredited because they had not completed the measures to correct points raised at the visits. Conclusions Numerous Italian endoscopy centers fail to meet important quality indicators. Our accreditation program can provide means for detecting these problems and correcting them by implementing SIED standards.

Metabolic syndrome is a risk factor for colorectal adenoma and cancer: a study in a White population using the harmonized criteria.

BACKGROUND: Metabolic syndrome (MetS) has been associated with colorectal adenomas and cancer. However, MetS definitions have changed over time, leading to a heterogeneity of patients included in previous studies and a substantial inextensibility of observations across time or eastern and western populations. Our aim was to evaluate the association of 'harmonized' criteria-defined MetS and its individual components with colorectal neoplasia and cancer in a western population. METHODS: In this multicenter, cross-sectional study, we prospectively evaluated consecutive outpatients who underwent open-access colonoscopy over a 3-month period. MetS was diagnosed according to the 2009 'harmonized' criteria. RESULTS: Out of 5707 patients enrolled, we found 213 cancers (3.7%), 1614 polyps (28.3%), 240 nonpolypoid lesions (4.2%), 95 laterally spreading tumors (1.6%). Polyps presented histological low-grade dysplasia in 72.9% of samples, while in 9.8%, high-grade dysplasia or in situ carcinoma was present; dysplasia rates for nonpolypoid lesions were 66.2% (low-grade) and 2.9% (high-grade/in situ carcinoma), while for laterally spreading tumors, 29.6% and 37%, respectively. Overall, MetS prevalence was 41.6%. MetS correlated with both adenomas [odds ratio (OR): 1.76, 95% confidence interval (CI) 1.54-2.00] and cancer (OR: 1.92, 95% CI 1.42-2.58). MetS was the only risk factor for such colonic lesions in subjects younger than 50 years. For all colonic neoplasia, we found MetS and not its individual components to be significantly associated. CONCLUSIONS: MetS is risk factor for cancer and adenoma in Whites, especially when younger than 50 years. MetS patients might be considered as a high-risk population also in colorectal cancer screening programs.

Application of the Biopsy-Sparing ESPGHAN Guidelines for Celiac Disease Diagnosis in Adults: A Real-Life Study.

BACKGROUND: Current adult celiac disease diagnosis requires histological confirmation. However, pediatric guidelines have proposed biopsy-sparing algorithms. AIMS: To explore the applicability of the ESPGHAN criteria and assess the accuracy of serology in predicting disease in adults. METHODS: We evaluated 234 consecutive adults showing elevated anti-tTG titers, EMA-positivity, and genetic susceptibility. Patients underwent upper endoscopy with duodenal biopsy. We determined optimal anti-tTG cutoff levels using ROC curves. RESULTS: Mean anti-tTG levels were 71.1 ± 66.5 U/ml; mean normalized levels were 14.8 ± 14.1 × ULN (mean ± SD). Partial/total villous atrophy was present in 36%/55% of cases, respectively. Anti-tTG levels correlated with histology (r s = 0.397, p < 0.001). AUC was similar before and after normalization (0.803 vs 0.807). Applying the ESPGHAN criterion (≥10 × ULN), we calculated a 97.66% PPV. ROC curve analysis showed an optimal cutoff of ≥16 × ULN, with a PPV of 98.86%. Eleven different assays were used for anti-tTG titer determination: Two were prevalent, labeled A (n = 141) and B (n = 59). They performed differently regarding disease prediction (AUC = 0.689 vs 0.925, p < 0.01), showing distinct optimal cutoff values (14.3 × ULN vs 3.7 × ULN), even after standardization (-0.14 vs -1.2). CONCLUSION: In adult symptomatic patients showing EMA-positivity and genetic susceptibility, anti-tTG titers correlated with histology. ESPGHAN criteria performed similarly to previous studies. However, a calculated 16 × ULN cutoff showed an improved PPV. Among prevalent assays, PPV peaked differently both after normalization and standardization, indicating intrinsic differences in performance, thus preventing uniform prediction of disease in a real-life setting. Assay-specific optimal cutoffs seem possible, but would complicate diagnostic criteria. However, biopsy-sparing strategies in adults could prove useful in challenging patients.

Iron deficiency anemia despite effective gluten-free diet in celiac disease: Diagnostic role of small bowel capsule endoscopy.

BACKGROUND & AIM: Iron deficiency anemia (IDA) is associated with celiac disease (CD). Although gluten-free diet (GFD) is an efficient treatment for CD, IDA remains an occasional finding during follow-up and correlates to inadequate gluten exclusion. Little is known regarding persistent IDA despite effective GFD. We aimed to evaluate the role of small bowel capsule endoscopy (SBCE) in this setting. METHODS: We prospectively included consecutive patients undergoing GFD for ≥24 months with persistent concomitant IDA. Patients were assessed serologically and, if negative, underwent endoscopic evaluation. RESULTS: Twenty-six patients underwent esophago-gastro-duodenoscopy (EGD), colonoscopy and SBCE. Altogether, 11 patients resulted positive. EGD showed mucosal lesions in 7: erosive gastritis (n=3), erosive duodenitis (n=1), active CD (n=3). Colonoscopy showed hemorrhoids in 2. SBCE was positive in 6 cases: erosive jejunitis (n=3, 1 eventually diagnosed as refractory CD, 2 as Crohn's disease), angiodysplasias (n=2), lymphangectasia (n=1). Some overlap was observed between procedures, since in 4 subjects EGD and SBCE produced significant findings. However, in 3 cases SBCE documented severe disease, not found at EGD. Hypoalbuminemia was significantly associated with a positive SBCE outcome (p<0.01). CONCLUSION: SBCE yielded significant findings in 23% of celiacs with persistent IDA despite adequate GFD. These were associated to hypoalbuminemia, indicating their occurrence at more severe stages of the disease.

Radiochemotherapy in Anal Cancer: cCR, clinical outcomes and quality of life using two different treatment schedules.

AIM: Main endpoint was a response rate to therapy; secondary endpoints were disease-free survival, overall survival, acute and late toxicities, specially in terms of anorectal and urinary continence. BACKGROUND: Radiochemotherapy for anal cancer achieves a good clinical response, locoregional control, anal function preservation. However, oncologic outcomes can differ using radiotherapy plus fluorouracil and mytomicin vs. cisplatin and fluorouracil. METHODS: Between 2000 and 2012, 27 anal cancer patients receiving radiotherapy combined with two different radiochemotherapy schedules, fluorouracil and mytomicin (group A) and cisplatin plus fluorouracil (group B). The Kaplan-Meier method was also used to estimate local control, overall survival and disease free survival. Statistical significance between curves was evaluated using the Log-rank test. RESULTS: Complete pathological response was found in 85.2% of patients, with higher rates of response in the group A (100% vs. 63.6%, p = 0.039). No significantly difference was found between the two groups for the other endpoints. Low rates of both acute and late toxicities were recorded. CONCLUSION: Radiotherapy plus fluorouracil and mytomicin provide a better complete pathological response than radiotherapy plus cisplatin and fluorouracil and a greater rate of anal sphincter function preservation. Globally, radiochemotherapy of the anal cancer provides excellent clinical outcomes with a good profile of acute and late toxicity, without difference between the two groups studied.

Obscure and occult gastrointestinal bleeding: comparison of different imaging modalities.

Patients with persistent, recurrent, or intermittent bleeding from the gastrointestinal (GI) tract for which no definite cause has been identified by initial esophagogastroduodenoscopy, colonoscopy, or conventional radiologic evaluation are considered to have an obscure GI bleeding (OGIB). The diagnosis and management of patients with OGIB is challenging, often requiring extensive and expensive workups. The main objective is the identification of the etiology and site of bleeding, which should be as rapidly accomplished as possible, in order to establish the most appropriate therapy. The introduction of capsule endoscopy and double balloon enteroscopy and the recent improvements in CT and MRI techniques have revolutionized the approach to patients with OGIB, allowing the visualization of the entire GI tract, particularly the small bowel, until now considered as the "dark continent" . In this article we review and compare the radiologic and endoscopic examinations currently used in occult and OGIB, focusing on diagnostic patterns, pitfalls, strengths, weaknesses, and value in patients' management.

Primary clarithromycin resistance in Helicobacter pylori: the Multicentric Italian Clarithromycin Resistance Observational (MICRO) study.

BACKGROUND: Primary clarithromycin resistance markedly reduces Helicobacter pylori eradication rate following standard therapies. Prevalence of primary clarithromycin resistance in H. pylori is increasing, and three point mutations are mainly involved. AIM. To assess both the prevalence of primary clarithromycin resistance in Italy, and the distribution of the involved point mutations. METHODS: Primary clarithromycin resistance was assessed by TaqMan real-time polymerase chain reaction on antral biopsies of 253 consecutive, H. pylori infected patients enrolled in 13 Italian centres between January and September 2010. RESULTS: Primary clarithromycin resistance was detected in 25 (9.9%) patients, with prevalence values widely ranging from 0 to 25%. Clarithromycin resistance rate was higher in female as compared to male patients (13.4% vs. 5.3%, p=0.03), and it tended to be higher in non-ulcer dyspepsia than in peptic ulcer patients (10.6% vs. 6.9%, p=0.5), female patients with non-ulcer dyspepsia showing the highest value (15.4%). The A2143G point mutation was detected in 13 (52.0%) patients, the A2142G in 9 (34.6%), whilst a double point mutation (A2143G plus A2142G) in 3 (11.6%) cases. CONCLUSIONS: Primary clarithromycin resistance is highly variable in different Italian geographic areas. High resistance rates were observed in female and in dyspeptic patients. Among the three point mutations of clarithromycin resistance, the A2143G remains the most frequently observed.

A prospective evaluation of iron deficiency anemia in the GI endoscopy setting: role of standard endoscopy, videocapsule endoscopy, and CT-enteroclysis.

BACKGROUND: Iron deficiency anemia (IDA) is a frequently encountered condition in clinical practice. After conventional endoscopy, the cause of anemia remains unknown in up to 40% of patients. OBJECTIVE: To evaluate prospectively the diagnostic efficacy of a systematic endoscopic approach to IDA and to compare the diagnostic yield of videocapsule endoscopy (VCE) and CT-enteroclysis in endoscopy-negative patients. DESIGN: Consecutive patients with IDA were enrolled prospectively. SETTING: Open-access endoscopy within an academic hospital. PATIENTS: This study involved 189 patients with IDA, including 98 women and 91 men; mean (±standard deviation) age 68 years±16.6 years. INTERVENTION: Patients with IDA underwent gastroscopy and colonoscopy plus ileoscopy. Endoscopy-negative patients were further blindly evaluated by both CT-enteroclysis and VCE. MAIN OUTCOME MEASUREMENTS: Diagnostic yield of conventional endoscopy; diagnostic yield of VCE versus CT-enteroclysis. RESULTS: Endoscopy results were positive in 144 of 189 patients (76.2%). CT-enteroclysis and VCE allowed a diagnosis in 37 of 45 endoscopy-negative patients (82.2%). Overall, VCE was superior to CT-enteroclysis (77.8% vs 22.2%; P<.001), in particular when flat lesions were found. LIMITATIONS: Single-center study. CONCLUSION: A systematic approach to IDA, which includes standard endoscopy, VCE, and CT-enteroclysis allows an overall diagnostic rate of 95.7%; however, CT-enteroclysis should be limited to cases of nondiagnostic VCE.

Obscure gastrointestinal bleeding and small bowel pathology: comparison between wireless capsule endoscopy and multidetector-row CT enteroclysis.

Obscure gastrointestinal bleeding is defined as bleeding of unknown origin, that persists or recurs after negative conventional barium contrast studies and upper and lower tract endoscopy. The causes of such a bleeding frequently arise in the small bowel, and they are represented by mucosal vascular abnormalities, neoplasms and other conditions such as Crohn's disease, Meckel's diverticulum, and vasculitis. Conventional barium contrast studies and push enteroscopy allow only a limited small bowel examination; moreover, intraoperative endoscopy may be inconclusive, since the small bowel is difficult to evaluate given its length and tortuous course. In the same way, angiographic diagnosis is stricktly related to the activity rate of hemorrhage. Wireless capsule endoscopy and multidetector-row CT enteroclysis are two recently developed minimally invasive techniques that may provide a complete small bowel examination, the first offering a direct visualization of the mucosal aspect, the second allowing evaluation of mural and extramural pathologies. This review is an update of the technique and clinical application of capsule endoscopy and multidetector-row CT enteroclysis in patients suffering from obscure small bowel bleeding.

Sensitivity disturbances in patients with irritable bowel syndrome and fibromyalgia.

BACKGROUND: Although visceral hypersensitivity is a common feature among patients with irritable bowel syndrome (IBS), studies on somatic sensitivity have given controversial results. AIM: To assess visceral sensitivity in response to isotonic rectal distensions and somatic sensitivity at different layers of the body wall (skin, subcutis, and muscle) in patients with IBS and fibromyalgia (FM), within and outside the area of abdominal pain referral. MATERIALS AND METHODS: We studied 10 patients with IBS, 5 patients with FM, 9 patients with IBS+FM, and 9 healthy controls. Rectal distensions were performed by increasing tension at 4 g steps up to 64 g or discomfort. Pain thresholds to electrical stimulation were measured within and outside the areas of abdominal pain referral. RESULTS: Patients with IBS and IBS+FM demonstrated rectal hypersensitivity in comparison to controls. The threshold of discomfort was 44 +/- 5 g in IBS and 36 +/- 5 in IBS+FM patients, while patients with FM and healthy controls tolerated all distensions without discomfort. In the areas of pain referral, pain thresholds of all three tissues of the body wall were lower than normal in all patients groups (p < 0.001). In control areas, the pain thresholds were normal in skin, and lower than normal in subcutis and muscle in IBS (p < 0.001). FM and IBS+FM demonstrated somatic hypersensitivity at all sites (p < 0.001 vs healthy). CONCLUSION: Our observations seem to indicate that, although sharing a common hypersensitivity background, multiple mechanisms may modulate perceptual somatic and visceral responses in patients with IBS and FM.

Visceral sensitivity and symptoms in patients with constipation- or diarrhea-predominant irritable bowel syndrome (IBS): effect of a low-fat intraduodenal infusion.

BACKGROUND: Visceral hypersensitivity is common in Irritable Bowel Syndrome (IBS) patients, and symptoms exacerbate postprandially. Yet the effects of nutrients on visceral sensitivity and symptoms in these patients have not been fully explored. AIMS: To evaluate the differences of visceral sensitivity and symptoms in healthy subjects and IBS patients during fasting and intraduodenal lipids infusion. METHODS: Graded rectal distensions at fixed tension levels were performed in 16 IBS patients (8 IBS-C and 8 IBS-D) and 6 healthy subjects before and during intraduodenal lipids infusion at 0.5 kcal/min. Tension levels were increased in 4 gr increments up to 64 gr or discomfort during both conditions. At each step, perception and symptoms were measured by means of a validated questionnaire. RESULTS: In basal conditions, perception thresholds in IBS patients and health were, respectively, 8 +/- 2 gr versus 32 +/- 9 gr (p < 0.001) with no changes during lipids. Intraduodenal lipids infusion significantly lowered threshold of discomfort in IBS patients in comparison to fasting (24 +/- 6 gr vs 34 +/- 4 gr; p < 0.05), while health tolerated all distension without discomfort. No differences of compliance, perception, or discomfort were observed between the two subgroups of patients at each tension step. The predominant symptom elicited in patients with IBS-C was abdominal pain (54%), while patients with IBS-D exhibited urgency (63%, p < 0.005); this pattern was maintained during lipids. CONCLUSIONS: Intraduodenal lipids increase visceral sensitivity in both IBS-C and IBS-D; symptoms specificity in response to rectal distension is maintained in the postprandial period. Lipids may be responsible for the postprandial symptoms exacerbation in IBS.