An Italian prospective multicenter study on colonoscopy practice and quality: What has changed in the last 10 years.

BACKGROUND: A relevant number of adenomas can be missed during colonoscopy. AIMS: Assess the current status of colonoscopy procedures in Italian centers. METHODS: A prospective observational study involving 17 hospitals (34 endoscopists) included consecutive patients undergoing standard colonoscopy. In the first phase, endoscopists performed consecutive colonoscopies. In the second phase, retraining via an online learning platform was planned, while in the third phase data were collected analogously to phase 1. RESULTS: A total of 3,504 patients were enrolled. Overall, a BBPS score ≥6 was obtained in 95.6% of cases (94.8% and 96.9% in the pre- and post-training phases, respectively). 88.4% of colonoscopies had a withdrawal time ≥6 min (88.2% and 88.7% in the pre- and post-training phases). Median adenoma detection rate (ADR) was 39.1%, with no significant differences between the pre- and post-training phases (40.1% vs 36.9%; P = 0.83). In total, 81% of endoscopists had a ADR performance above the 25% threshold. CONCLUSION: High colonoscopy quality standards are achieved by the Italian hospitals involved. Quality improvement initiatives and repeated module-based colonoscopy-training have been promoted in Italy during the last decade, which appear to have had a significant impact on quality colonoscopy metrics together with the activation of colorectal cancer screening programs.

Effects of Attendance to an Organized Fecal Immunochemical Test Screening Program on the Risk of Colorectal Cancer: An Observational Cohort Study.

BACKGROUND & AIMS: This cohort study compared colorectal cancer (CRC) incidence and mortality between people who participated in an Italian regional biennial fecal immunochemical test (FIT) screening program and people who did not. METHODS: The program started in 2005. The target population included over 1,000,000 people aged 50 to 69 years. The FIT was a one-sample OC-Sensor (Eiken Chemical Co, Tokyo, Japan) (cutoff, ≥20 µg hemoglobin/g feces). The average annual response rate to invitation was 51.4%. The records of people invited up to June 2016 were extracted from the screening data warehouse. Attenders were subjects who responded to the first 2 invitations or to the single invitation sent them before they became ineligible. Non-attenders were subjects who did not respond to any of these invitations. The records were linked with the regional CRC registry. People registered up to December 2016 were identified. Self-selection-adjusted incidence rate ratios (IRRs) and incidence-based CRC mortality rate ratios (MRRs) for attenders to non-attenders, with 95% confidence intervals (CIs), were calculated. RESULTS: The cohort generated 2,622,131 man-years and 2,887,845 woman-years at risk with 4490 and 3309 CRC cases, respectively. The cohort of attenders was associated with an IRR of 0.65 (95% CI, 0.61-0.69) for men, 0.75 (95% CI, 0.70-0.80) for women and 0.69 (95% CI, 0.66-0.72) for both sexes combined. The self-selection-adjusted IRR was 0.67 (95% CI, 0.62-0.72) for men and 0.79 (95% CI, 0.72-0.88) for women. The IRR for stage I, II, III, and IV CRC was 1.35 (95% CI, 1.20-1.50), 0.61 (95% CI, 0.53-0.69), 0.60 (95% CI, 0.53-0.68) and 0.28 (95% CI, 0.24-0.32) for men and 1.64 (95% CI, 1.43-1.89), 0.60 (95% CI, 0.52-0.69), 0.73 (95% CI, 0.63-0.85) and 0.35 (95% CI, 0.30-0.42) for women. The overall incidence-based CRC MRR was 0.32 (95% CI, 0.28-0.37) for men, 0.40 (95% CI, 0.34-0.47) for women and 0.35 (95% CI, 0.31-0.39) for both sexes combined. The adjusted MRR was 0.35 (95% CI, 0.29-0.41) for men and 0.46 (95% CI, 0.37-0.58) for women. CONCLUSIONS: Attendance to a FIT screening program is associated with a CRC incidence reduction of 33% among men and 21% among women, and a CRC mortality reduction of 65% and 54%, respectively.

A new panenteric capsule endoscopy-based strategy in patients with melena and a negative upper gastrointestinal endoscopy: a prospective feasibility study.

OBJECTIVE: patients presenting with melena and nondiagnostic esophagogastroduodenoscopy are usually investigated with colonoscopy and if negative, with small bowel capsule endoscopy. In this pilot study, we tested feasibility and performance of panenteric capsule endoscopy (PCE) in patients presenting with melena and negative esophagogastroduodenoscopy. METHODS: Between January and December 2018, consecutive patients presenting with melena, clinically significant bleeding and negative esophagogastroduodenoscopy were invited to undergo PCE by swallowing PillCam Colon 2 (Medtronic Inc., Dublin, Ireland). PCE results, further diagnostic or therapeutic examinations, rebleeding rates at 30 days and 12 months were recorded. RESULTS: Out of 128 patients with melena, 23 had negative esophagogastroduodenoscopy. Of them, 12 (8 female, mean age 76 years) underwent PCE, which allowed complete small bowel and colonic evaluation in 12 (100%) and 11 (91.7%) patients, respectively. The small bowel and colon cleansing were adequate in 100 and 83.3%, respectively. No PCE-related complications were observed. The PCE diagnostic yield was 83.3%: significant findings were located in the small bowel, colon or both in 5 (41.7%), 4 (33.3%) and 1 (8.3%) patients, respectively. Device-assisted enteroscopy was performed in 6 (50%) patients. Thirty days and 1 year rebleeding rates were 0 and 18.1%, respectively. CONCLUSIONS: In this proof-of-concept study, PCE was feasible and safe in patients with melena and negative esophagogastroduodenoscopy, identifying the bleeding site in 83% of patients. PCE lead to small bowel therapeutic interventions in 50% of patients, thus avoiding unnecessary standard colonoscopy. Further large prospective randomized studies investigating this strategy are warranted.

Safety and protection in endoscopic services during phase II of COVID-19 pandemic: a national survey.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic requires appropriate measures for containing infection spreading. Endoscopic procedures are considered at increased risk of infection transmission. We evaluated organizational aspects and personal behaviours in Italian Endoscopic Units during phase II of the pandemic. METHODS: A questionnaire on organizational aspects and use of personal protective equipment (PPE) were e-mailed to gastroenterologists working in Endoscopic Units. Data were analysed accordingly to the National Health Institute and Gastroenterology Societies recommendations. RESULTS: Data of 117 centres were collected, and different shortcomings emerged. Specific protocols for containing infection and training programs for operators were lacking in 20 and 30% of centres, respectively, and telephone triage 24-72 h before the endoscopy was not implemented in 25% of hospitals. In 30% of centres, the slot time for endoscopies and between examinations was not prolonged. PPE, masks, shirts and gloves were universally adopted, although with some differences. In 20% of centres, a FFPE-FFP3 mask was not adopted during endoscopic examinations. Postendoscopy patient tracking/contact was completed in only one-third of centres. CONCLUSIONS: Our survey provides information on organizational and medical behaviours during COVID-19 phase II in Italy, which could be useful for adopting appropriate measures for containing COVID-19 spread during phase II.

Right-sided diverticulosis is an independent risk factor for bleeding in patients admitted for diverticular disease.

BACKGROUND: Diverticular bleeding is the main cause of lower gastrointestinal bleeding in both Eastern and Western countries. Several risk factors have been identified, such as comorbidities and concomitant medications. In Eastern population, the prevalence of right-side diverticulosis is higher than in Western one, and some Authors identified bilateral diverticulosis as a risk factor for bleeding. AIMS: To identify risk factors for diverticular bleeding in patients admitted for diverticular disease (DD). METHODS: All patients admitted for DD from January 2017 to December 2018 were retrieved from the hospital Information System. For each patient, age, gender, clinical presentation and concomitant medication were recorded. All patient underwent imaging assessment (computed tomography, ultrasound or MRI) and colonoscopy during hospitalization or within one month. RESULTS: Among 1248 patients discharged with a diagnosis of DD during the study period, 293 (52.2% male, median age 75 years) were finally analyzed; of them, 105 (35.8%) for diverticular bleeding. On multivariate analysis, male gender (OR 4.27), age (OR 1.12), anti-thrombotic medications (OR 2.60) and right-sided DD (OR 5.70) were independently correlated to diverticular bleeding. CONCLUSION: Our study provides evidence that, together with age, male gender and concomitant anti-thrombotic treatment, right-sided DD represents an independent risk factor for bleeding.

Proportional incidence of interval colorectal cancer in a large population-based faecal immunochemical test screening programme.

BACKGROUND: The European guidelines for quality assurance in colorectal cancer (CRC) screening recommend that interval cancer rate be expressed as a proportion of background incidence rate. AIM: To determine the crude and adjusted proportional incidence of interval CRC in an Italian regional two-yearly faecal immunochemical test (FIT) screening programme. METHODS: The programme (year of implementation, 2005) is targeted at over 1,000,000 people aged 50-69 years. The test is a one-sample OC-Sensor (Eiken Chemical Co., Tokyo, Japan). The study covered one-third of the regional area. Excerpts of 434,295 eligible negative FIT records dated 2005-2012 from 193,193 subjects were retrieved from the regional CRC screening data warehouse. By 31 December 2013, the cohort accumulated 198,302 man-years and 235,370 woman-years. Interval CRCs were identified by record-linkage with the local population-based cancer registry. Their number was divided by the expected number, estimated with age-period-cohort models, to obtain the proportional incidence. RESULTS: The proportional incidence of interval CRC for men and women was, respectively, 0.06 (95% confidence interval (CI), 0.04-0.09) and 0.17 (95% CI, 0.13-0.23) in the first interval year, and 0.21 (95% CI, 0.16-0.26) and 0.28 (95% CI, 0.22-0.36) in the second year. CONCLUSIONS: The results were acceptable and in line with previous studies.

Five common errors to avoid in clinical practice: the Italian Association of Hospital Gastroenterologists and Endoscopists (AIGO) Choosing Wisely Campaign.

Modern medicine provides almost infinite diagnostic and therapeutic possibilities if compared to the past. As a result, patients undergo a multiplication of tests and therapies, which in turn may trigger further tests, often based on physicians' attitudes or beliefs, which are not always evidence-based. The Italian Association of Hospital Gastroenterologists and Endoscopists (AIGO) adhered to the Choosing Wisely Campaign to promote an informed, evidence-based approach to gastroenterological problems. The aim of this article is to report the five recommendations of the AIGO Choosing Wisely Campaign, and the process used to develop them. The AIGO members' suggestions regarding inappropriate practices/interventions were collected. One hundred and twenty-one items were identified. Among these, five items were selected and five recommendations were developed. The five recommendations developed were: (1) Do not request a fecal occult blood test outside the colorectal cancer screening programme; (2) Do not repeat surveillance colonoscopy for polyps, after a quality colonoscopy, before the interval suggested by the gastroenterologist on the colonoscopy report, or based on the polyp histology report; (3) Do not repeat esophagogastroduodenoscopy in patients with reflux symptoms, with or without hiatal hernia, in the absence of different symptoms or alarm symptoms; (4) Do not repeat abdominal ultrasound in asymptomatic patients with small hepatic haemangiomas (diameter < 3 cm) once the diagnosis has been established conclusively; (5) Do not routinely prescribe proton pump inhibitors within the context of steroid use or long-term in patients with functional dyspepsia. AIGO adhered to the Choosing Wisely Campaign and developed five recommendations. Further studies are needed to assess the impact of these recommendations in clinical practice with regards to clinical outcome and cost-effectiveness.

Current uses and outcomes of lumen-apposing metal stents.

The lumen-apposing metal stent (LAMS) is one of the revolutionary devices recently developed for gastrointestinal endoscopy. This device has a saddle-shaped design and large lumen. It was originally designed for drainage of transmural pancreatic fluid collection and in the last few years it has been used extensively for that indication. More recently, other in- and off-label indications have been proposed. Several types of LAMS are available, with or without an electrocautery-enhanced delivery system. In the current review we discuss the state of the art with regard to LAMS and their indications, usage, and outcomes.

Long-term efficacy of vacuum-assisted therapy (Endo-SPONGE®) in large anastomotic leakages following anterior rectal resection.

BACKGROUND: The aim of our study was to test the long-term efficacy of Endo-SPONGE® therapy in a group of patients treated in our center with vacuum-assisted therapy because of anastomotic leakages after colorectal surgery. METHODS: Eleven patients [male: 6; mean age: 71 (range: 44-82) years] who had anastomotic leakage treated with Endo-SPONGE® placement were included in the study. Patient records were examined retrospectively. All patients with documented anastomotic leakage on abdominal computed tomography following an anterior resection of the rectum for rectal cancer underwent sigmoidoscopy to determine the extent of the anastomotic defect and the size of the presacral abscess. RESULTS: Ten of the 11 patients (90.9%) showed closure of the anastomotic leakage after a mean of 16 sponge changes. During follow up [mean: 29 (range: 6-64) months], we observed two cases of anastomotic stricture. Treatment failure was observed in one patient who presented an increased size of dehiscence after 23 sessions of endoscopic treatment, despite an initial good response. CONCLUSIONS: Our study substantially confirms previous conclusions and reaffirms that Endo-SPONGE® treatment for colorectal anastomotic leakages, performed in suitable patients, represents a successful and safe approach. The reduction in wound closure time, mild-to-moderate discomfort and possibly shorter hospitalization suggest that Endo-SPONGE® treatment can be a prominent therapeutic regimen with adequate patient acceptance.

Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial.

BACKGROUND AND STUDY AIM: The study compared the efficacy of bowel cleansing using a low-volume mixed preparation (15 mg bisacodyl plus 2 L polyethylene glycol [PEG] solution) versus a standard high-volume preparation (4 L PEG) in patients with previous colorectal resection. PATIENTS AND METHODS: A total of 120 patients with prior colorectal resection for cancer undergoing surveillance colonoscopy were randomized to receive either a split-dose low-volume (n = 60) or high-volume (n = 60) preparation for bowel cleansing. The quality of bowel preparation, rated according to a modified Ottawa Bowel Preparation scale (mOBPS), represented the primary outcome measure. Tolerability, safety, and lesion detection rates were secondary outcomes. RESULTS: No significant difference was observed between the low-volume and high-volume preparations in achievement of adequate cleansing (i. e. mOBPS ≤ 4; low-volume vs. high-volume group, 85.0 % vs. 81.7 %, P = 0.624). The low-volume preparation showed a higher success rate for cleansing of the right colon (P = 0.025); better tolerability in terms of intake of the whole amount of the preparation (P < 0.001) was also observed. According to the logistic regression analysis, the only predictors of unsuccessful cleansing were previous left colectomy (P = 0.012) and a longer elapsed time since the intervention (P = 0.034). Lesion detection rates were comparable between the groups. No serious adverse events were reported. CONCLUSION: A low-volume preparation is not inferior to a high-volume preparation for adequate bowel cleansing in patients with prior colorectal resection for cancer. If larger, multicenter, prospective studies confirm our findings, a low-volume preparation will represent a more tolerable option for such patients. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov identifier NCT01887158.

Colonoscopic surveillance of first-degree relatives of colorectal cancer patients in a faecal occult blood screening programme.

BACKGROUND: In some Italian areas, colonoscopic surveillance of first-degree relatives (FDRs) of colorectal cancer (CRC) patients is provided as a part of local population-based faecal occult blood test (FOBT) screening programmes. The objective of the present study was to assess the feasibility and early results of this surveillance model. METHODS: Data from district screening centres were used to evaluate the process of identification and selection of eligible FDRs (residence in the Emilia-Romagna Region, age 40-75 years, no recent colonoscopy) of screen-detected CRC patients and the detected prevalence of disease. The probability for an FDR to undergo colonoscopy and to be diagnosed with CRC and advanced adenoma was estimated using the Kaplan-Meier method. The sex- and age-standardised ratio of detected prevalence to that expected based on results from a colonoscopy screening study of the Italian general population was estimated. RESULTS: Between 2005 and 2011, 9319 FDRs of 2437 screen-detected CRC patients (3.8 per patient) were identified and contacted. Their likelihood of being eligible for, and accepting, colonoscopy was 0.11 (95% confidence interval: 0.11-0.12). Among the 926 subjects undergoing colonoscopy, the prevalence of previous negative screening FOBT was 63%. Eleven CRCs (1.2%) and 100 advanced adenomas (10.8%) were detected. The standardised ratio of detected prevalence to that expected was 0.91 (95% confidence interval: 0.19-2.66) for CRC and 1.48 (1.04-2.05) for advanced adenoma. CONCLUSIONS: The procedure of selection of FDRs was extremely ineffective. Due to previous negative screening tests, the prevalence of disease was less than expected. A population-based FOBT screening programme is a highly unsuitable setting for the provision of surveillance to FDRs of CRC patients.

MiroCam capsule for obscure gastrointestinal bleeding: a prospective, single centre experience.

BACKGROUND: Capsule endoscopy is an established tool for the evaluation of obscure gastrointestinal bleeding but published literature is mostly limited to PillCam SB (Given Imaging, Israel). AIMS: The aims of this study were to determine the findings, the diagnostic yield and the rebleeding rate in a series of patients with overt or occult obscure gastrointestinal bleeding studied with MiroCam(Intromedic, Seoul, Korea) capsule endoscopy. METHODS: Data of 118 patients who underwent capsule endoscopy for overt or occult obscure gastrointestinal bleeding were prospectively collected between March 2009 and March 2011. RESULTS: Evaluation of the entire small bowel (completion rate) was achieved in 96% of cases. Relevant lesions occurred in 58% of patients. Angiodysplasias was the most common finding. Six patients (9% of the positive findings) had a non-small-bowel lesion detected by capsule. The yield of capsule endoscopy in the overt group was greater than in the occult group but without achieving a significant difference (61% vs. 54%, p>0.05). Rebleeding rate was lower in patients with a negative examination (6%) than in patients with a positive one (17%) (p=0.03). Capsule retention was registered in 3 of 118 patients (2.5%). CONCLUSIONS: MiroCam capsule endoscopy is a safe and effective tool for exploring small bowel with a high completion rate.

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.