Combination of Mucosa-Exposure Device and Computer-Aided Detection for Adenoma Detection During Colonoscopy: A Randomized Trial.

BACKGROUND & AIMS: Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. METHODS: Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. RESULTS: From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00-1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04-1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69-1.14; P = .38). CONCLUSIONS: The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone. CLINICALTRIALS: gov, Number: NCT04676308.

Nasogastric tube in mechanical ventilated patients: ETCO2 and pH measuring to confirm correct placement. A pilot study.

INTRODUCTION: Nasogastric tube (NGT) placement is a procedure commonly performed in mechanically ventilated (MV) patients. Chest X-Ray is the diagnostic gold-standard to confirm its correct placement, with the downsides of requiring MV patients' mobilization and of intrinsic actinic risk. Other potential methods to confirm NGT placement have shown lower accuracy compared to chest X-ray; end-tidal CO2 (ETCO2) and pH analysis have already been singularly investigated as an alternative to the gold standard. Aim of this study was to determine threshold values in ETCO2 and pH measurement at which correct NGT positioning can be confirmed with the highest accuracy. MATERIALS & METHODS: This was a prospective, multicenter, observational trial; a continuous cohort of eligible patients was allocated with site into two arms. Patients underwent general anesthesia, orotracheal intubation and MV; in the first and second group we respectively assessed the difference between tracheal and esophageal ETCO2 and between esophageal and gastric pH values. RESULTS: From November 2020 to March 2021, 85 consecutive patients were enrolled: 40 in the ETCO2 group and 45 in the pH group. The ETCO2 ROC analysis for predicting NGT tracheal misplacement demonstrated an optimal ETCO2 cutoff value of 25.5 mmHg, with both sensitivity and specificity reaching 1.0 (AUC 1.0, p < 0.001). The pH ROC analysis for predicting NGT correct gastric placement resulted in an optimal pH cutoff value of 4.25, with mild diagnostic accuracy (AUC 0.79, p < 0.001). DISCUSSION: In patients receiving MV, ETCO2 and pH measurements respectively identified incorrect and correct NGT placement, allowing the identification of threshold values potentially able to improve correct NGT positioning. TRIAL REGISTRATION: NCT03934515 (www.clinicaltrials.gov).

Artificial intelligence and colonoscopy experience: lessons from two randomised trials.

BACKGROUND AND AIMS: Artificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1). METHODS: In this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40-80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting. RESULTS: In 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis. CONCLUSIONS: In less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR. TRIAL REGISTRATION NUMBER: NCT:04260321.

Association between autism spectrum disorder and inflammatory bowel disease: A systematic review and meta-analysis.

Children with autism spectrum disorder (ASD) are frequently diagnosed with co-occurring medical conditions including inflammatory bowel disease (IBD). To investigate the association, we conducted a systematic review registered in PROSPERO (ID:CRD42021236263) with a random-effects meta-analysis. We searched PubMed, Embase, and PsycInfo (last search on January 25, 2021), and manually searched relevant publications. We included observational studies measuring the association between ASD and IBD. The primary outcome was the association (odds ratio, OR) between ASD and later development of IBD. Sensitivity analyses were conducted by quality, confounding adjustment, and study design. We performed meta-regression analyses and assessed heterogeneity, publication bias, and quality of studies with the Newcastle-Ottawa Scale. Overall, we included six studies consisting of eight datasets, including over 11 million participants. We found that ASD was significantly associated with subsequent incident IBD (any IBD, OR = 1.66, 95% confidence interval[CI] = 1.25-2.21, p < 0.001; ulcerative colitis, OR = 1.91, 95%CI = 1.41-2.6, p < 0.001; Crohn's disease, OR = 1.47, 95%CI = 1.15-1.88, p = 0.002). ASD and IBD were also associated regardless of temporal sequence of diagnosis (any IBD, OR = 1.57, 95%CI = 1.28-1.93, p < 0.001; ulcerative colitis, OR = 1.7, 95%CI = 1.36-2.12, p < 0.001; Crohn's disease, OR = 1.37, 95%CI = 1.12-1.69, p = 0.003). Sensitivity analyses confirmed the findings of the main analysis. Meta-regression did not identify any significant moderators. Publication bias was not detected. Quality was high in four datasets and medium in four. In conclusion, our findings highlight the need to screen for IBD in individuals with ASD, and future research should identify who, among those with ASD, has the highest risk of IBD, and elucidate the shared biological mechanisms between ASD and IBD. LAY SUMMARY: This systematic review and meta-analysis of eight observational datasets found that individuals with autism spectrum disorder (ASD) are more likely to develop any inflammatory bowel disease, ulcerative colitis, or Crohn's disease. Our findings highlight the need to screen for inflammatory bowel disease in patients with ASD and elucidate the shared biological mechanisms between the two disorders.

Computer-aided detection versus advanced imaging for detection of colorectal neoplasia: a systematic review and network meta-analysis.

BACKGROUND: Computer-aided detection (CADe) techniques based on artificial intelligence algorithms can assist endoscopists in detecting colorectal neoplasia. CADe has been associated with an increased adenoma detection rate, a key quality indicator, but the utility of CADe compared with existing advanced imaging techniques and distal attachment devices is unclear. METHODS: For this systematic review and network meta-analysis, we did a comprehensive search of PubMed/Medline, Embase, and Scopus databases from inception to Nov 30, 2020, for randomised controlled trials investigating the effectiveness of the following endoscopic techniques in detecting colorectal neoplasia: CADe, high definition (HD) white-light endoscopy, chromoendoscopy, or add-on devices (ie, systems that increase mucosal visualisation, such as full spectrum endoscopy [FUSE] or G-EYE balloon endoscopy). We collected data on adenoma detection rates, sessile serrated lesion detection rates, the proportion of large adenomas detected per colonoscopy, and withdrawal times. A frequentist framework, random-effects network meta-analysis was done to compare artificial intelligence with chromoendoscopy, increased mucosal visualisation systems, and HD white-light endoscopy (the control group). We estimated odds ratios (ORs) for the adenoma detection rate, sessile serrated lesion detection rate, and proportion of large adenomas detected per colonoscopy, and calculated mean differences for withdrawal time, with 95% CIs. Risk of bias and certainty of evidence were assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. FINDINGS: 50 randomised controlled trials, comprising 34 445 participants, were included in our main analysis (six trials of CADe, 18 of chromoendoscopy, and 26 of increased mucosal visualisation systems). HD white-light endoscopy was the control technique in all 50 studies. Compared with the control technique, the adenoma detection rate was 7·4% higher with CADe (OR 1·78 [95% CI 1·44-2·18]), 4·4% higher with chromoendoscopy (1·22 [1·08-1·39]), and 4·1% higher with increased mucosal visualisation systems (1·16 [1·04-1·28]). CADe ranked as the superior technique for adenoma detection (with moderate confidence in hierarchical ranking); cross-comparisons of CADe with other imaging techniques showed a significant increase in the adenoma detection rate with CADe versus increased mucosal visualisation systems (OR 1·54 [95% CI 1·22-1·94]; low certainty of evidence) and with CADe versus chromoendoscopy (1·45 [1·14-1·85]; moderate certainty of evidence). When focusing on large adenomas (≥10 mm) there was a significant increase in the detection of large adenomas only with CADe (OR 1·69 [95% CI 1·10-2·60], moderate certainty of evidence) when compared to HD white-light endoscopy; CADe ranked as the superior strategy for detection of large adenomas. CADe also seemed to be the superior strategy for detection of sessile serrated lesions (with moderate confidence in hierarchical ranking), although no significant increase in the sessile serrated lesion detection rate was shown (OR 1·37 [95% CI 0·65-2·88]). No significant difference in withdrawal time was reported for CADe compared with the other techniques. INTERPRETATION: Based on the published literature, detection rates of colorectal neoplasia are higher with CADe than with other techniques such as chromoendoscopy or tools that increase mucosal visualisation, supporting wider incorporation of CADe strategies into community endoscopy services. FUNDING: None.

Clinical Adverse Events after Endoscopic Resection for Colorectal Lesions: A Meta-Analysis on the Antibiotic Prophylaxis.

BACKGROUND: Post-polypectomy coagulation syndrome (PECS) is a well-known adverse event after endoscopic polypectomy for colorectal lesions. To date, there are no standardized guidelines for the antimicrobial prophylaxis. The aim of this meta-analysis is to evaluate the usefulness of antibiotics in patients undergoing endoscopic mucosal or submucosal resections. METHODS: A comprehensive literature search of PubMed, MEDLINE, EMBASE, and Web of Science databases was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies investigating the role of prophylactic antibiotic administration in reducing the PECS after endoscopic polypectomy were considered. The terms used to search were ("antimicrobial"OR"antibiotics"OR"prophylaxis"OR"prophylactic") AND ("resection"OR"polypectomy"OR"dissection") AND ("endoscopic"OR"mucosal"OR"submucosal") AND ("colon"OR"colorectal"OR"colonic"OR"rectum"). Data of included studies were collected and analysed. RESULTS: The literature search revealed 262 articles, 3 of whom were randomized trials and one was a retrospective study. Patients included were 850 (548 treated with antibiotics and 302 received no treatment). The overall incidence rate was 2.4 and 19.9% in treatment and control groups, respectively. The pooled analysis showed a reduction of 83% of postoperative events in the antibiotics group (relative risk 0.181; 95% CI 0.100-0.326, p < 0.001). CONCLUSIONS: In our meta-analysis, the antibiotic prophylaxis showed a positive effect in reducing the incidence of postoperative adverse events other than perforation and bleeding in patients treated with endoscopic mucosal resection and endoscopic submucosal dissection for colorectal lesions. Despite the low-level of evidence of this meta-analysis, the antibiotic prophylaxis should be taken into account. Further multicenter, large-sample, randomized controlled studies are needed to confirm our results and to evaluate whether specific subgroups of patients could actually benefit from an antibiotic prophylaxis.

A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial.

BACKGROUND AND AIMS: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions. METHODS: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant. RESULTS: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P < .001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P < .001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P = .1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P = .04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P = .052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P = .1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment. CONCLUSIONS: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.).

Role of out of hours primary care service in limiting inappropriate access to emergency department.

Out of hours (OOH) doctors can have an important gate-keeping role over the access to the emergency department (ED), but the outcome and the quality of their ED referrals have been poorly studied. We aimed to investigate the outcome of patients referred to ED from OOH service and the determinants of admission or short-stay dispositions. We collected retrospectively data about referrals to ED from a local OOH service in the north-east of Italy using the OOH paper register and the ED electronic database, over the period of 01/10/2012 to 31/03/2013. Out of 5217 patients accessing the OOH service, 408 referrals were included in our analysis. 45.3% (185) of the referrals were admitted to hospital or the short-stay unit, 26 patients (=6.4%) were discharged as non-urgent outgoing codes after no specialist consultation or test, suggesting inappropriate referrals, and, of the remaining 197 (=48%), only 10 did not undergo any investigation or consultation. Significant determinants of admission were: age ≥65 years (OR = 2.619; 95% CI 1.528-4.491, p < 0.0001), domiciliary examination (OR = 2.168; 95% CI 1.353-3.476, p = 0.001), nursing home/palliative care setting (OR = 2.563; 95% CI 1.228-5.351, p = 0.012) and OOH triage code, ranging from an OR of 7.47 (95% CI 3.028-18.433) for minor urgencies to an OR of 26.835 (95% CI 6.761-106.508, p < 0.0001) for emergencies, in comparison to no urgent codes. OOH service seems to play an effective gate-keeping role limiting ED access. Determinants of admission to hospital suggest some simple interventions that could improve the adequacy of ED referral from OOH service.

Predictors of emergency department referral in patients using out-of-hours primary care services.

BACKGROUND: Out of hours (OOH) doctors could manage many cases limiting the inappropriate accesses to ED. However the possible determinants of referral to ED by OOH doctors are poorly studied. We aimed to characterize patients referred from the OOH to ED service in order to explore the gate-keeping role of OOH service for hospital emergency care and to facilitate future research in improving its cost-effectiveness. METHODS: A retrospective study was made through data collection of 5217 contacts in a local OOH service in the North-East of Italy (from 10/01/2012 to 03/31/2013). RESULTS: Only 8.7% (=454 people) of the total contacts were referred to ED. In the multivariate analysis, the significant predictors of being sent to ED were: age; residence in nursing home (odds ratios (OR)=2.00, 95%CI: 1.30-3.10); being visited by a OOH physician (OR=2.64, 95%CI: 2.09-3.34). Taking infections as reference, cardiovascular diseases (OR=18.31, 95%CI: 12.01-27.90), traumas (OR=8.75, 95%CI: 5.36-14.26) and gastrointestinal conditions (OR=7.69, 95%CI: 4.70-11.91) increased the probability to be referred to ED. CONCLUSIONS: OOH service addresses several common medical conditions in community-dwelling and in nursing home context, supporting its filtering function for the ED access. The main reasons of ED access could be a crucial aspect in general population education in order to avoid the overcrowding of the ED.