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Background and study aim: Computer-aided detection (CADe) has been developed to improve detection during colonoscopy. After initial reports of high efficacy, there has been an increasing recognition of variability in the effectiveness of CADe systems. The aim of this study was to evaluate a CADe system (PENTAX Medical, Tokyo, Japan) in a varied colonoscopy population. Patients and methods: A multicenter, randomized trial was conducted at 7 hospitals (both university and non-university) in Europe and Canada. Participants referred for diagnostic, non-iFOBT screening, or surveillance colonoscopy were randomized (1:1) to undergo CADe-assisted or conventional colonoscopy (CC) by experienced endoscopists. Participants with insufficient bowel preparation were excluded from the analysis. Primary outcome was adenoma detection rate (ADR). Secondary outcomes included adenomas per colonoscopy (APC) and sessile serrated lesions per colonoscopy (SSLPC). Results: In total, 581 participants were enrolled, of which 497 were included in the final analysis: 250 in the CADe-arm and 247 in the CC-arm. Surveillance was the indication in 202/497 (40.6%) colonoscopies, diagnostic in 199/497 (40.0%), and non-iFOBT screening in 96/497 (19.3%). Overall, ADR (38.4% vs. 37.7%; p=0.43) and APC (0.66 vs. 0.66; p=0.97) were similar between CADe and CC. SSLPC was increased (0.30 vs. 0.19; p=0.049) in the CADe-arm vs. CC. Conclusions: In this study conducted by experienced endoscopists, CADe did not result in a statistically significant increase in ADR. However, the ADR of our control group substantially surpassed our sample size assumptions, increasing the risk of an underpowered trial. (Trialsearch.who.int:NL9135).

This study tested the hypothesis that bowel preparation with mannitol should not affect the colonic concentration of H2 and CH4. Therefore, the SATISFACTION study, an international, multicenter, randomized, parallel-group phase II–III study investigated this issue. The phase II dose-finding part of the study evaluated H2, CH4, and O2 concentrations in 179 patients randomized to treatment with 50 g, 100 g, or 150 g mannitol. Phase III of the study compared the presence of intestinal gases in 680 patients randomized (1:1) to receive mannitol 100 g in single dose or a standard split-dose 2 L polyethylene glycol (PEG)-Asc preparation (2 L PEG-Asc). Phase II results showed that mannitol did not influence the concentration of intestinal gases. During phase III, no patient in either group had H2 or CH4 concentrations above the critical thresholds. In patients with H2 and/or CH4 levels above detectable concentrations, the mean values were below the risk thresholds by at least one order of magnitude. The results also highlighted the effectiveness of standard washing and insufflation maneuvers in removing residual intestinal gases. In conclusion, bowel cleansing with mannitol was safe as the concentrations of H2 and CH4 were the same as those found in patients prepared with 2 L PEG-Asc. In both groups, the concentrations of gases were influenced more by the degree of cleansing achieved and the insufflation and washing maneuvers performed than by the preparation used for bowel cleansing. The trial protocol was registered with ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT04759885) and with EudraCT (eudract_number: 2019-002856-18).

This study aimed to define the pharmacokinetics (PKs) of oral mannitol used as an osmotic laxative for bowel preparation for colonoscopy. The PKs of oral mannitol was evaluated in a substudy as part of a phase II dose-finding, international, multicenter, randomized, parallel-group, endoscopist-blinded study. Patients were randomly assigned to take 50, 100, or 150 g mannitol. Venous blood samples were drawn at baseline (T0), 1 h (T1), 2 h (T2), 4 h (T4), and 8 h (T8) after completion of mannitol self-administration. The mean mannitol plasma concentrations (mg/ml) were dose-dependent with a consistent difference among doses. The mean maximum concentration (Cmax) ± SD was 0.63 ± 0.15, 1.02 ± 0.28, and 1.36 ± 0.39 mg/ml, in the three dosage groups, respectively. The mean area under the curve from zero to infinity (AUC0−∞) was 2.667 ± 0.668, 4.992 ± 1.706, and 7.403 ± 3.472 mg/ml*h in the 50, 100, and 150 g mannitol dose groups, respectively. Bioavailability was similar in the three dose groups and was just over 20% (0.243 ± 0.073, 0.209 ± 0.081, and 0.228 ± 0.093 in the 50, 100, and 150 g mannitol dose groups, respectively). The present study showed that the bioavailability of oral mannitol is just over 20% and is similar for the three tested doses (50, 100, and 150 g). The linear increase in Cmax, AUC0−t8, and AUC0−∞ must be considered when choosing the oral mannitol dose for bowel preparation to avoid its systemic osmotic effects.

Background To date, no scale has been validated to assess bubbles associated with bowel preparation. This study aimed to develop and assess the reliability of a novel scale - the Colon Endoscopic Bubble Scale (CEBuS). Methods This was a multicenter, prospective, observational study with two online evaluation phases of 45 randomly distributed still colonoscopy images (15 per scale grade). Observers assessed images twice, 2 weeks apart, using CEBuS (CEBuS-0 - no or minimal bubbles, covering<5% of the surface; CEBuS-1 - bubbles covering 5%-50%; CEBuS-2 - bubbles covering >50%) and reporting the clinical action (do nothing; wash with water; wash with simethicone). Results CEBuS provided high levels of agreement both in evaluation Phase 1 (4 experts) and Phase 2 (6 experts and 13 non-experts), with almost perfect intraobserver reliability: kappa 0.82 (95% confidence interval 0.75-0.88) and 0.86 (0.85-0.88); interobserver agreement - intraclass correlation coefficient (ICC) 0.83 (0.73-0.89) and 0.90 (0.86-0.94). Previous endoscopic experience had no influence on agreement among experts vs. non-experts: kappa 0.86 (0.80-0.91) vs. 0.87 (0.84-0.89) and ICC 0.91 (0.87-0.94) vs. 0.90 (0.86-0.94), respectively. Interobserver agreement on clinical action was ICC 0.63 (0.43-0.78) in Phase 1 and 0.77 (0.68-0.84) in Phase 2.Absolute agreement on clinical action per scale grade was 85% (82-88) for CEBuS-0, 21% (16-26) for CEBuS-1, and 74% (70-78) for CEBuS-2. Conclusion CEBuS proved to be a reliable instrument to standardize the evaluation of colonic bubbles during colonoscopy. Assessment in daily practice is warranted.

Background & Aims: Hospitalization is associated with inadequate colon cleansing before colonoscopy. We aimed to identify factors associated to inadequate colon cleansing among inpatients, and to derive and validate a model to identify inpatients with inadequate cleansing. Methods: We performed a prospective observational study at 12 hospitals in Italy. Consecutive adult inpatients scheduled for colonoscopy for any indication were enrolled from February through May 2019 (derivation cohort, n = 1016) and from June through August 2019 (validation cohort, n = 508). Inadequate cleansing was defined as Boston bowel preparation scale scores below 2 in any colon segment. We performed multivariate logistic regression to identify factors associated with inadequate cleansing. Results: In the combined cohorts, 1032 patients (68%) had adequate colon cleansing. Physicians’ meetings to optimize bowel preparation (odds ratio [OR], 0.42; 95% CI, 0.27–0.65), written and oral instructions to patients (OR, 0.48; 95% CI, 0.36–0.65), admission to gastroenterology unit (OR, 0.71; 95% CI, 0.51–0.98), split-dose regimens (OR, 0.27; 95% CI, 0.20–0.35), a 1-liter polyethylene glycol-based bowel purge (OR, 0.39; 95% CI, 0.23—0.65), and 75% or more intake of bowel preparation (OR, 0.09; 95% CI, 0.05–0.15) significantly reduced odds of inadequate colon cleansing. Alternatively, bedridden status (OR, 2.14; 95% CI, 1.55–2.98), constipation (OR, 2.16; 95% CI, 1.55–3.0), diabetes mellitus (OR, 1.61; 95% CI, 1.18–2.20), use of anti-psychotic drugs (OR, 3.26; 95% CI, 1.62–6.56), and 7 or more days of hospitalization (OR, 1.02; 95% CI, 1.00–1.04) increased risk of inadequate colon cleansing. We developed a model to identify patients with inadequate cleaning using data from patients in the derivation cohort and tested it in the validation cohort. Calibration values were P = .218 for the discrimination cohort and P = .232 for the validation cohort. Discrimination values were c-statistic, 0.78 (95% C

Background Ischemic colitis (IC) is caused by a transient hypo-perfusion of the colon leading to mucosal ulcerations, inflammation, and hemorrhage. The primary aim was to identify predictive factors of endoscopic severity of IC. Secondary endpoints were to show epidemiology, clinical presentation, endoscopic findings, and outcomes of IC. Methods In this single-center retrospective analysis, IC was scored according to endoscopy as: grade 1 (hyperemia, <1 cm erosions and non-confluent ulcers); grade 2 (>1 cm superficial, partially confluent ulcers); and grade 3 (deep or diffuse ulcers or necrosis). Then, IC was grouped into low-(grade 1) and high-grade (grades 2 and 3). Significant (P≤0.1) independent factor of severe IC at univariate analysis were entered into multivariate analysis and considered significant at P<0.05. Results 227 patients (male:female 60:167; mean age 72.7±16.2 years) were included. IC was scored as grade 1 in 137/227 (60.4%), grade 2 in 62/227 (27.3%), and grade 3 in 28/227 (12.3%) patients. At univariate analysis, age (74.9 vs. 71.3 years; P=0.09), diabetes (14.4% vs. 12.4%; P=0.09), and leukocytosis or creatinine elevation (74.4% vs. 60.6%; P=0.032) were associated with endoscopic high-grade IC. At multivariate analysis, leukocytosis and creatinine levels remained associated with high-grade IC (44.7% vs. 29.9%; odds ratio 1.92, 95% confidence interval 1.07-3.52; P=0.030). Conclusions Although confounding factors cannot be excluded due to study design and patients’ characteristics, leukocytosis and/or creatinine elevation at hospital admission were significantly related with endoscopic high-grade IC and might be used to stratify patients for the need of endoscopy.

Background and Aims: Adequate bowel cleansing is critical to ensure quality and safety of a colonoscopy. A novel 1-L polyethylene glycol plus ascorbate (1L-PEG+ASC) regimen was previously validated against low-volume regimens but was never compared with high-volume regimens. Methods: In a phase IV study, patients undergoing colonoscopy were randomized 1:1 to receive split-dose 1L PEG+ASC or a split-dose 4-L PEG-based regimen (4L-PEG) in 5 Italian centers. Preparation was assessed with the Boston Bowel Preparation Scale (BBPS) by local endoscopists and centralized reading, both blinded to the randomization arm. The primary endpoint was noninferiority of 1L-PEG+ASC in colon cleansing. Secondary endpoints were superiority of 1L-PEG+ASC, patient compliance, segmental colon cleansing, adenoma detection rate, tolerability, and safety. Results: Three hundred eighty-eight patients (median age, 59.8 years) were randomized between January 2019 and October 2019: 195 to 1L-PEG+ASC and 193 to 4L-PEG. Noninferiority of 1L-PEG+ASC was demonstrated for cleansing in both the entire colon (BBPS ≥ 6: 97.9% vs 93%; relative risk [RR], 1.03; 95% confidence interval [CI], 1.001-1.04; P superiority = .027) and in the right-sided colon segment (98.4% vs 96.0%; RR, 1.02; 95% CI, .99-1.02; P noninferiority = .013). Compliance was higher with 1L-PEG+ASC than with 4L-PEG (178/192 [92.7%] vs 154/190 patients [81.1%]; RR, 1.10; 95% CI, 1.05-1.12), whereas no difference was found regarding safety (moderate/severe side effects: 20.8% vs 25.8%; P = .253). No difference in adenoma detection rate (38.8% vs 43.0%) was found. Conclusions: One-liter PEG+ASC showed noninferiority compared with 4L-PEG in achieving adequate colon cleansing and provided a higher patient compliance. No differences in tolerability and safety were detected. (Clinical trial registration number: NCT03742232.)

The present manuscript aims to review the history, recent advances, evidence, and challenges of artificial intelligence (AI) in colonoscopy. Although it is mainly focused on polyp detection and characterization, it also considers other potential applications (i.e., inflammatory bowel disease) and future perspectives. Some of the most recent algorithms show promising results that are similar to human expert performance. The integration of AI in routine clinical practice will be challenging, with significant issues to overcome (i.e., regulatory, reimbursement). Medico-legal issues will also need to be addressed. With the exception of an AI system that is already available in selected countries (GI Genius; Medtronic, Minneapolis, MN, USA), the majority of the technology is still in its infancy and has not yet been proven to reach a sufficient diagnostic performance to be adopted in the clinical practice. However, larger players will enter the arena of AI in the next few months.

Background âPatients with prior colon cancer have increased risk of metachronous colorectal neoplasms; therefore, endoscopic surveillance is indicated. Current recommendations are not risk-stratified. We investigated predictive factors for colorectal neoplasms to build a model to spare colonoscopies for low-risk patients. Methods â This was a multicenter, retrospective study including patients who underwent surgery for colon cancer in 2001âŠ-âŠ2008 (derivation cohort) and 2009âŠ-âŠ2013 (validation cohort). A predictive model for neoplasm occurrence at second surveillance colonoscopy was developed and validated. Results â 421 and 203 patients were included in derivation and validation cohort, respectively. At second surveillance colonoscopy, 112 (26.6âŠ%) and 55 (27.1âŠ%) patients had metachronous neoplasms in derivation and validation groups; three cancers were detected in the latter. History of left-sided colon cancer (OR 1.64, 95âŠ%CI 1.02âŠ-âŠ2.64), ≥âŠ1 advanced adenoma at index colonoscopy (OR 1.90, 95âŠ%CI 1.05âŠ-âŠ3.43), and ≥âŠ1 adenoma at first surveillance colonoscopy (OR 2.06, 95âŠ%CI 1.29âŠ-âŠ3.27) were independently predictive of metachronous colorectal neoplasms at second surveillance colonoscopy. For patients without such risk factors, diagnostic accuracy parameters were: 89.3âŠ% (95âŠ%CI 82.0âŠ%-94.3âŠ%) and 78.2âŠ% (95âŠ%CI 65.0âŠ%-88.2âŠ%) sensitivity, and 28.5âŠ% (95âŠ%CI 23.5âŠ%-33.9âŠ%) and 33.8âŠ% (95âŠ%CI 26.2âŠ%-42.0âŠ%) specificity in derivation and validation group, respectively. No cancer would be missed. Conclusions â Patients with prior left-sided colon cancer or ≥âŠ1 advanced adenoma at index colonoscopy or ≥âŠ1 adenoma at first surveillance colonoscopy had a significantly higher risk of neoplasms at second surveillance colonoscopy; patients without such factors had much lower risk and could safely skip the second surveillance colonoscopy. A prospective, multicent