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.

Efficacy and safety of endoscopic ultrasound-guided hepatico-gastrostomy: a meta-regression analysis.

BACKGROUND AND STUDY AIM: EUS-guided hepaticogastrostomy (EUS-HGS) is a valid option for EUS-guided biliary drainage that has been increasingly used in the last decade. The aims of the study were to provide a systematic review with meta-analysis and meta-regression of features and outcomes of this procedure. METHODS: MEDLINE, Scopus, Web-of-Science, and Cochrane databases were searched for literature pertinent to EUS-HGS. Meta-analysis of proportions and meta-regression of potential modifiers of the main outcome measures were applied. The main outcome was technical success. Secondary outcomes were clinical success and procedure-related adverse events (AEs). RESULTS: Thirty-three studies including 1644 patients were included in the meta-analysis. Malignant biliary obstruction was the underlying cause in almost all (99.6%) cases; the main indications for EUS-HGS were duodenal/papillary invasion (34.8%), surgical altered anatomy (18.4%) and hilar stenosis (16%). Pooled technical success of EUS-HGS was 97.7% (95%-CI: 96.1-99%, I2=0%), the intention to treat (ITT) clinical success was 88.1% (95%-CI: 84.7-91.2%, I2=33.9%) and procedure-related AEs occurred in 12% (95%-CI: 9.8-14.5%, I2=20.4%), being cholangitis/sepsis (2.8%) and bleeding (2.3%) the most frequent. The rate of procedure related AEs was reduced with the use of dedicated stents at the univariable meta regression analysis. Meta-regression showed that technical success and clinical success rates were modified by centers' experience (>4/year). CONCLUSIONS: EUS-HGS represents an effective and safe procedure for EUS-guided biliary drainage in patients with malignant biliary obstruction. Future studies should address the impact of center experience, patient selection, and use of dedicated stents to improve this technique's performance.

Comparative diagnostic yield of different endoscopic techniques for tissue sampling of upper gastrointestinal subepithelial lesions: a network meta-analysis.

BACKGROUND: There is limited evidence on the comparative diagnostic performance of endoscopic tissue sampling techniques for subepithelial lesions. We performed a systematic review with network meta-analysis to compare these techniques. METHODS: A systematic literature review was conducted for randomized controlled trials (RCTs) comparing the sample adequacy and diagnostic accuracy of bite-on-bite biopsy, mucosal incision-assisted biopsy (MIAB), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and EUS-guided fine-needle biopsy (FNB). Results were expressed as relative risk (RR) and 95%CI. RESULTS: Eight RCTs were identified. EUS-FNB was significantly superior to EUS-FNA in terms of sample adequacy (RR 1.20 [95%CI 1.05-1.45]), whereas none of the other techniques significantly outperformed EUS-FNA. Additionally, bite-on-bite biopsy was significantly inferior to EUS-FNB (RR 0.55 [95%CI 0.33-0.98]). Overall, EUS-FNB appeared to be the best technique (surface under cumulative ranking [SUCRA] score 0.90) followed by MIAB (SUCRA 0.83), whereas bite-on-bite biopsy showed the poorest performance. When considering lesions <20 mm, MIAB, but not EUS-FNB, showed significantly higher accuracy rates compared with EUS-FNA (RR 1.68 [95%CI 1.02-2.88]). Overall, MIAB ranked as the best intervention for lesions <20 mm (SUCRA score 0.86 for adequacy and 0.91 for accuracy), with EUS-FNB only slightly superior to EUS-FNA. When rapid on-site cytological evaluation (ROSE) was available, no difference between EUS-FNB, EUS-FNA, and MIAB was observed. CONCLUSION: EUS-FNB and MIAB appeared to provide better performance, whereas bite-on-bite sampling was significantly inferior to the other techniques. MIAB seemed to be the best option for smaller lesions, whereas EUS-FNA remained competitive when ROSE was available.

Real-Time Computer-Aided Detection of Colorectal Neoplasia During Colonoscopy : A Systematic Review and Meta-analysis.

BACKGROUND: Artificial intelligence computer-aided detection (CADe) of colorectal neoplasia during colonoscopy may increase adenoma detection rates (ADRs) and reduce adenoma miss rates, but it may increase overdiagnosis and overtreatment of nonneoplastic polyps. PURPOSE: To quantify the benefits and harms of CADe in randomized trials. DESIGN: Systematic review and meta-analysis. (PROSPERO: CRD42022293181). DATA SOURCES: Medline, Embase, and Scopus databases through February 2023. STUDY SELECTION: Randomized trials comparing CADe-assisted with standard colonoscopy for polyp and cancer detection. DATA EXTRACTION: Adenoma detection rate (proportion of patients with ≥1 adenoma), number of adenomas detected per colonoscopy, advanced adenoma (≥10 mm with high-grade dysplasia and villous histology), number of serrated lesions per colonoscopy, and adenoma miss rate were extracted as benefit outcomes. Number of polypectomies for nonneoplastic lesions and withdrawal time were extracted as harm outcomes. For each outcome, studies were pooled using a random-effects model. Certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. DATA SYNTHESIS: Twenty-one randomized trials on 18 232 patients were included. The ADR was higher in the CADe group than in the standard colonoscopy group (44.0% vs. 35.9%; relative risk, 1.24 [95% CI, 1.16 to 1.33]; low-certainty evidence), corresponding to a 55% (risk ratio, 0.45 [CI, 0.35 to 0.58]) relative reduction in miss rate (moderate-certainty evidence). More nonneoplastic polyps were removed in the CADe than the standard group (0.52 vs. 0.34 per colonoscopy; mean difference [MD], 0.18 polypectomy [CI, 0.11 to 0.26 polypectomy]; low-certainty evidence). Mean inspection time increased only marginally with CADe (MD, 0.47 minute [CI, 0.23 to 0.72 minute]; moderate-certainty evidence). LIMITATIONS: This review focused on surrogates of patient-important outcomes. Most patients, however, may consider cancer incidence and cancer-related mortality important outcomes. The effect of CADe on such patient-important outcomes remains unclear. CONCLUSION: The use of CADe for polyp detection during colonoscopy results in increased detection of adenomas but not advanced adenomas and in higher rates of unnecessary removal of nonneoplastic polyps. PRIMARY FUNDING SOURCE: European Commission Horizon 2020 Marie Sklodowska-Curie Individual Fellowship.

The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.

BACKGROUND: Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy. METHODS: This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate. RESULTS: A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding. CONCLUSIONS: Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.

From Staining Techniques to Artificial Intelligence: A Review of Colorectal Polyps Characterization.

This review article provides a comprehensive overview of the evolving techniques in image-enhanced endoscopy (IEE) for the characterization of colorectal polyps, and the potential of artificial intelligence (AI) in revolutionizing the diagnostic accuracy of endoscopy. We discuss the historical use of dye-spray and virtual chromoendoscopy for the characterization of colorectal polyps, which are now being replaced with more advanced technologies. Specifically, we focus on the application of AI to create a "virtual biopsy" for the detection and characterization of colorectal polyps, with potential for replacing histopathological diagnosis. The incorporation of AI has the potential to provide an evolutionary learning system that aids in the diagnosis and management of patients with the best possible outcomes. A detailed analysis of the literature supporting AI-assisted diagnostic techniques for the detection and characterization of colorectal polyps, with a particular emphasis on AI's characterization mechanism, is provided. The benefits of AI over traditional IEE techniques, including the reduction in human error in diagnosis, and its potential to provide an accurate diagnosis with similar accuracy to the gold standard are presented. However, the need for large-scale testing of AI in clinical practice and the importance of integrating patient data into the diagnostic process are acknowledged. In conclusion, the constant evolution of IEE technology and the potential for AI to revolutionize the field of endoscopy in the future are presented.

Italian Survey on Endoscopic Biliary Drainage Approach in Patients with Surgically Altered Anatomy.

Background and Objectives: Biliary drainage (BD) in patients with surgically altered anatomy (SAA) could be obtained endoscopically with different techniques or with a percutaneous approach. Every endoscopic technique could be challenging and not clearly superior over another. The aim of this survey is to explore which is the standard BD approach in patients with SAA. Materials and Methods: A 34-question online survey was sent to different Italian tertiary and non-tertiary endoscopic centers performing interventional biliopancreatic endoscopy. The core of the survey was focused on the first-line and alternative BD approaches to SAA patients with benign or malignant obstruction. Results: Out of 70 centers, 39 answered the survey (response rate: 56%). Only 48.7% of them declared themselves to be reference centers for endoscopic BD in SAA. The total number of procedures performed per year is usually low, especially in non-tertiary centers; however, they have a low tendency to refer to more experienced centers. In the case of Billroth-II reconstruction, the majority of centers declared that they use a duodenoscope or forward-viewing scope in both benign and malignant diseases as a first approach. However, in the case of failure, the BD approach becomes extremely heterogeneous among centers without any technique prevailing over the others. Interestingly, in the case of Roux-en-Y, a significant proportion of centers declared that they choose the percutaneous approach in both benign (35.1%) and malignant obstruction (32.4%) as a first option. In the case of a previous failed attempt at BD in Roux-en-Y, the subsequent most used approach is the EUS-guided intervention in both benign and malignant indications. Conclusions: This survey shows that the endoscopic BD approach is extremely heterogeneous, especially in patients with Roux-en-Y reconstruction or after ERCP failure in Billroth-II reconstruction. Percutaneous BD is still taken into account by a significant proportion of centers in the case of Roux-en-Y anatomy. The total number of endoscopic BD procedures performed in non-tertiary centers is usually low, but this result does not correspond to an adequate rate of referral to more experienced centers.

Management of Malignant Gastric Outlet Obstruction: A Comprehensive Review on the Old, the Classic and the Innovative Approaches.

Gastrojejunostomy is the principal method of palliation for unresectable malignant gastric outlet obstructions (GOO). Gastrojejunostomy was traditionally performed as a surgical procedure with an open approach butrecently, notable progress in the development of minimally invasive procedures such as laparoscopic gastrojejunostomies have emerged. Additionally, advancements in endoscopic techniques, including endoscopic stenting (ES) and endoscopic ultrasound-guided gastroenterostomy (EUS-GE), are becoming more prominent. ES involves the placement of self-expandable metal stents (SEMS) to restore luminal patency. ES is commonly the first choice for patients deemed unfit for surgery or at high surgical risk. However, although ES leads to rapid improvement of symptoms, it carries limitations like higher stent dysfunction rates and the need for frequent re-interventions. Recently, EUS-GE has emerged as a potential alternative, combining the minimally invasive nature of the endoscopic approach with the long-lasting effects of a gastrojejunostomy. Having reviewed the advantages and disadvantages of these different techniques, this article aims to provide a comprehensive review regarding the management of unresectable malignant GOO.

Variability in adenoma detection rate in control groups of randomized colonoscopy trials: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Adenoma detection rate (ADR) is still the main surrogate outcome parameter of screening colonoscopy, but most studies include mixed indications, and basic ADR is quite variable. We therefore looked at the control groups in randomized ADR trials using advanced imaging or mechanical methods to find out whether indications or other factors influence ADR levels. METHODS: Patients in the control groups of randomized controlled trials (RCTs) on ADR increase using various methods were collected based on a systematic review; this control group had to use high-definition white-light endoscopy performed between 2008 and 2021. Random-effects meta-analysis was used to pool ADR in control groups and its 95% confidence interval (CI) according to clinical (indication and demographic), study setting (tandem/parallel, number of centers, sample size), and technical (type of intervention, withdrawal time) parameters. Interstudy heterogeneity was reported with the I2 statistic. Multivariable mixed-effects meta-regression was performed for potentially relevant variables. RESULTS: From 80 studies, 25,304 patients in the respective control groups were included. ADR in control arms varied between 8.2% and 68.1% with a high degree of heterogeneity (I2 = 95.1%; random-effect pooled value, 37.5%; 95% CI, 34.6‒40.5). There was no difference in ADR levels between primary colonoscopy screening (12 RCTs, 15%) and mixed indications including screening/surveillance and diagnostic colonoscopy; however, fecal immunochemical testing as an indication for colonoscopy was an independent predictor of ADR (odds ratio [OR], 1.6; 95% CI, 1.1-2.4). Other well-known parameters were confirmed by our analysis such as age (OR, 1.038; 95% CI, 1.004-1.074), sex (male sex: OR, 1.02; 95% CI, 1.01-1.03), and withdrawal time (OR, 1.1; 95% CI, 1.0-1.1). The type of intervention (imaging vs mechanical) had no influence, but methodologic factors did: More recent year of publication and smaller sample size were associated with higher ADR. CONCLUSIONS: A high level of variability was found in the level of ADR in the control groups of RCTs. With regards to indications, only fecal immunochemical test-based colonoscopy studies influenced basic ADR, and primary colonoscopy screening appeared to be similar to other indications. Standardization for variables related to clinical, methodologic, and technical parameters is required to achieve generalizability and reproducibility.

Comparative diagnostic performance of different techniques for EUS-guided fine-needle biopsy sampling of solid pancreatic masses: a network meta-analysis.

BACKGROUND AND AIMS: Evidence is limited on the comparative diagnostic performance of tissue sampling techniques for EUS-guided fine-needle biopsy sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare these techniques. METHODS: Rates of sample adequacy, blood contamination, and tissue integrity using fine-needle biopsy sampling needles were evaluated. Direct and indirect comparisons were performed among the slow-pull, dry-suction, modified wet-suction, or no-suction techniques. Results are expressed as risk ratio (RR) and 95% confidence interval (CI). RESULTS: Overall, 9 randomized controlled trials (756 patients) were identified. On network meta-analysis, the no-suction technique was significantly inferior to the other techniques (RR, .85 [95% CI, .78-.92] vs slow pull; RR, .85 [95% CI, .78-.92] vs dry suction; RR, .83 [95% CI, .76-.90] vs modified wet suction) in terms of sample adequacy. Consequently, modified wet suction was shown to be the best technique (surface under the cumulative ranking curve score, .90), with the no-suction technique showing poorer performance in terms of sample adequacy (surface under the cumulative ranking curve score, .14). Dry suction was associated with significantly higher rates of blood contamination as compared with the slow-pull technique (RR, 1.44; 95% CI, 1.15-1.80), whereas no suction led to less blood contamination of samples in comparison with other techniques (RR, .71 [95% CI, .52-.97] vs slow pull; RR, .49 [95% CI, .36-.66] vs dry suction; RR, .57 [95% CI, .40-.81] vs modified wet suction). The modified wet-suction technique significantly outperformed dry suction in terms of tissue integrity of the sample (RR, 1.36; 95% CI, 1.06-1.75). CONCLUSIONS: Modified wet suction seemed to provide high rates of integrity and adequate samples, albeit with high blood contamination. The no-suction technique performed significantly worse than other sampling strategies.

EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience.

BACKGROUND AND AIMS: EUS-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMSs) has been reported as a rescue treatment with encouraging results for the relief of jaundice in patients with distal malignant biliary obstruction (DMBO) and after failure of both ERCP and EUS-guided choledochoduodenostomy. METHODS: This was a multicenter retrospective analysis of all cases of consecutive EUS-GBD with LAMSs used as a rescue treatment for patients with DMBO in 14 Italian centers from June 2015 to June 2020. Primary endpoints were technical and clinical success, whereas the secondary endpoint was the adverse event (AE) rate. RESULTS: Forty-eight patients (52.1% women) with a mean age of 74.3 ± 11.7 years were included in the study. Biliary stricture was related to pancreatic adenocarcinoma (85.4%), duodenal adenocarcinoma (2.1%), cholangiocarcinoma (4.2%), ampullary cancer (2.1%), colon cancer (4.2%), and metastatic breast cancer (2.1%). The mean diameter of the common bile duct was 13.3 ± 2.8 mm. LAMSs were placed transgastrically in 58.3% of cases and transduodenally in 41.7%. Technical success was 100%, whereas clinical success was 81.3%, with a mean total bilirubin reduction after 2 weeks of 66.5%. The mean procedure time was 26.4 minutes, and the mean hospital stay was 9.2 ± 8.2 days. AEs occurred in 5 patients (10.4%): 3 were classified as intraprocedural and 2 were classified as delayed because they occurred after >15 days. When the American Society for Gastrointestinal Endoscopy lexicon was used, 2 AEs were mild and 3 were moderate (2 buried LAMSs). The mean follow-up was 122 days. CONCLUSIONS: Our study shows that EUS-GBD with LAMSs used as a rescue treatment for patients affected by DMBO represents a valuable option in terms of technical and clinical success rates, with an acceptable AE rate. To the best of our knowledge, this is the largest study concerning the use of this procedure. (Clinical trial registration number: NCT03903523.).

Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series.

BACKGROUND AND AIMS: The role of the newer EUS fine-needle biopsy needles in lymphadenopathies (LAs) is still under evaluation. We aimed to evaluate the diagnostic accuracy and adverse event rate of EUS-guided fine-needle biopsy sampling (EUS-FNB) in diagnosing LAs. METHODS: From June 2015 to June 2022, all patients referred to 4 institutions for EUS-FNB of mediastinal and abdominal LAs were enrolled. Twenty-two-gauge Franseen tip or 25-gauge fork-tip needles were used. The criterion standard for positive results was surgery or imaging and clinical evolution over a follow-up of at least 1 year. RESULTS: One hundred consecutive patients were enrolled, consisting of those with a new diagnosis of LA (40%), presence of LA with a previous history of neoplasia (51%), or suspected lymphoproliferative disease (9%). EUS-FNB was technically feasible in all LA patients with 2 to 3 passes (mean, 2.62 ± .93). The overall sensitivity, positive predictive value, specificity, negative predictive value, and accuracy for EUS-FNB were 96.20%, 100%, 100%, 87.50%, and 97.00%, respectively. Histologic analysis was feasible in 89% of cases. Cytologic evaluation was performed in 67% of specimens. A statistical difference between the accuracy of the 22-gauge or 25-gauge needle (P = .63) was not found. A subanalysis on lymphoproliferative disease revealed a sensitivity and accuracy of 89.29% and 90.0%, respectively. No adverse events were recorded. CONCLUSIONS: EUS-FNB with new end-cutting needles is a valuable and safe method to diagnose LAs. The high quality of histologic cores and the good amount of tissue allowed a complete immunohistochemical analysis of metastatic LAs and precise subtyping of the lymphomas. (Clinical trial registration number: NCT02855151.).

The Use of PuraStat® in the Management of Walled-Off Pancreatic Necrosis Drained Using Lumen-Apposing Metal Stents: A Case Series.

Background and Objectives: Bleeding is one of the most feared and frequent adverse events in the case of EUS-guided drainage of WOPN using lumen-apposing metal stents (LAMSs) and of direct endoscopic necrosectomy (DEN). When it occurs, its management is still controversial. In the last few years, PuraStat, a novel hemostatic peptide gel has been introduced, expanding the toolbox of the endoscopic hemostatic agents. The aim of this case series was to evaluate the safety and efficacy of PuraStat in preventing and controlling bleeding of WOPN drainage using LAMSs. Materials and Methods: This is a multicenter, retrospective pilot study from three high-volume centers in Italy, including all consecutive patients treated with the novel hemostatic peptide gel after LAMSs placement for the drainage of symptomatic WOPN between 2019 and 2022. Results: A total of 10 patients were included. All patients underwent at least one session of DEN. Technical success of PuraStat was achieved in 100% of patients. In seven cases PuraStat was placed for post-DEN bleeding prevention, with one patient experiencing bleeding after DEN. In three cases, on the other hand, PuraStat was placed to manage active bleeding: two cases of oozing were successfully controlled with gel application, and a massive spurting from a retroperitoneal vessel required subsequent angiography. No re-bleeding occurred. No PuraStat-related adverse events were reported. Conclusions: This novel peptide gel could represent a promising hemostatic device, both in preventing and managing active bleeding after EUS-guided drainage of WON. Further prospective studies are needed to confirm its efficacy.

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.

EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP. METHODS: This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success. Secondary endpoints were the assessment of the adverse event (AE) rate and variables associated with technical success. RESULTS: Two hundred fifty-six patients (44.9% women) with a mean age of 73.9 ± 12.6 years were included in the study. The most common etiology of DMBO was pancreatic adenocarcinoma (75%), followed by ampullary cancer (8.6%) and cholangiocarcinoma (6.6%). The common bile duct median diameter was 17.3 ± 3.9 mm. Technical and clinical success were achieved in 239 of 256 (93.3%), and 230 of 239 (96.2%) patients, respectively. The mean follow-up was 151 ± 162 days. Twenty-seven AEs occurred in 25 of 239 patients (10.5%) (3 mild, 21 moderate, and 3 severe). No fatal AEs occurred. Reinterventions to manage AEs with endoscopic or radiologic procedures occurred in 22 patients (9.2%). CONCLUSIONS: The results of our study show that EUS-CDS with LAMSs in patients with DMBO and failed ERCP represent a viable alternative in terms of effectiveness and safety with acceptable AE rates. (Clinical trial registration number: NCT03903523.).

Definition of a hospital volume threshold to optimize outcomes after drainage of pancreatic fluid collections with lumen-apposing metal stents: a nationwide cohort study.

BACKGROUND AND AIMS: There is increasing interest in expanding the use of lumen-apposing metal stents (LAMSs) in patients with pancreatic fluid collections (PFCs). The aim of this study was to determine whether there is a hospital volume threshold for which patient outcomes could be optimized. METHODS: Data from a large multicenter series of patients with PFCs treated with LAMSs were retrieved. Rate of adverse events (AEs) was the primary outcome. Multivariable models with restricted cubic splines were used to identify a hospital volume threshold by plotting hospital volume against the log odds ratio (OR) of AE rate. Propensity score matching was applied to obtain 2 well-balanced groups according to hospital volume, and univariate/multivariate logistic regression analysis was performed to identify significant predictors of AEs. RESULTS: Overall, 516 patients were included. Increasing hospital volume was associated with a reduced AE rate (P = .03), and the likelihood of experiencing an AE declined as hospital volume increased up to 15 cases. After propensity score matching, 175 patients in the high-volume (>15 cases) and 132 in the low-volume hospital group were compared. Overall, 41 AEs were observed (13.3%), of which 14 (8%) and 27 (20.4%) occurred at high-volume and low-volume centers, respectively (P = .001). Severe and fatal events were observed more frequently in low-volume centers (6% vs 1.7% and 2.2% vs 0%, respectively; P = .05). In multivariate analysis, main pancreatic duct injury (OR, 2.62; 95% confidence interval [CI], 1.26-4.67; P = .02), presence of abnormal vessels (OR, 2.93; 95% CI, 1.41-5.02; P = .006), and institutional experience (OR, 2.95; 95% CI, 1.48-5.90; P = .002) were significant predictors of AEs. CONCLUSIONS: With 15 procedures representing the minimum number of cases associated with the lowest risk for postprocedural AEs, hospital volume is associated with improved outcomes. (Clinical trial registration number: NCT03903523.).

Comparing the number and relevance of false activations between 2 artificial intelligence computer-aided detection systems: the NOISE study.

BACKGROUND AND AIMS: Artificial intelligence has been shown to be effective in polyp detection, and multiple computer-aided detection (CADe) systems have been developed. False-positive (FP) activation emerged as a possible way to benchmark CADe performance in clinical practice. The aim of this study was to validate a previously developed classification of FPs comparing the performances of different brands of approved CADe systems. METHODS: We compared 2 different consecutive video libraries (40 video per arm) collected at Humanitas Research Hospital with 2 different CADe system brands (CADe A and CADe B). For each video, the number of CADe false activations, cause, and time spent by the endoscopist to examine the area erroneously highlighted were reported. The FP activations were classified according to the previously developed classification of FPs (the NOISE classification) according to their cause and relevance. RESULTS: In CADe A 1021 FP activations were registered across the 40 videos (25.5 ± 12.2 FPs per colonoscopy), whereas in CADe B 1028 were identified (25.7 ± 13.2 FPs per colonoscopy; P = .53). Among them, 22.9 ± 9.9 (89.8% in CADe A) and 22.1 ± 10.0 (86.0% in CADe B) were because of artifacts from the bowel wall. Conversely, 2.6 ± 1.9 (10.2% in CADe A) and 3.5 ± 2.1 (14% in CADe B) were caused by bowel content (P = .45). Within CADe A each false activation required .2 ± .9 seconds, with 1.6 ± 1.0 FPs (6.3%) requiring additional time for endoscopic assessment. Comparable results were reported within CADe B with .2 ± .8 seconds spent per false activation and 1.8 ± 1.2 FPs per colonoscopy requiring additional inspection. CONCLUSIONS: The use of a standardized nomenclature provided comparable results with either of the 2 recently approved CADe systems. (Clinical trial registration number: NCT04399590.).

Sporadic non-ampullary duodenal adenomas: efficacy and outcomes of endoscopic resection.

BACKGROUND AND AIMS: Sporadic non-ampullary duodenal adenomas (SNDAs) are often referred to tertiary centers because of the challenges in endoscopic resection. There is a paucity of data on both technical and clinical outcomes. The aim of our study was to evaluate the efficacy and safety of endoscopic resection for the treatment of SNDA in two western centers. METHODS: This is a retrospective study reporting data of a cohort of patients referred for resection of SNDA between 2013 and 2017. Patients with familial adenomatous polyposis or ampullary lesions were excluded from present analysis. Outcomes considered for this study were technical success, adverse events, recurrence and need for surgery. RESULTS: 120 patients (mean age 66 ± 11.9 years, 64male) were enrolled in the study. Mean size of the lesions was 23.3 mm (range 5-80). Fifty-six en-bloc endoscopic mucosal resection (EMR) (46.6%), 41 piecemeal EMR (pEMR) and 23 endoscopic submucosal dissection were performed. Intra-procedural perforation was observed in 4 patients (3.3%). Fourteen post-procedural (11.6%) adverse events were recorded. All post-procedural perforations occurred in lesions > 30 mm. Recurrence was observed in 11 patients (9.5%) during a mean follow-up of 29 months. All recurrences were successfully managed endoscopically. 119 patients were still alive at last follow-up. CONCLUSION: Endoscopic resection can be successfully carried out in majority of patients. Size > 30 mm seems to be the predictor of high adverse events risk.

Relief of jaundice in malignant biliary obstruction: When should we consider endoscopic ultrasonography-guided hepaticogastrostomy as an option?

BACKGROUND: Since it was first described in 2001, endoscopic ultrasonography-guided biliary drainage (EUS-BD) has emerged as an alternative procedure for achieving an endoscopic internal drainage in case of endoscopic retrograde cholangiopancreatography (ERCP) failure. Biliary drainage can be achieved by either a transduodenal extrahepatic approach through EUS-guided choledochoduodenostomy (EUS-CDS), or a transgastric intrahepatic approach, namely EUS-guided hepaticogastrostomy (EUS-HGS) which already holds a remarkable place in the treatment of patients with malignant biliary obstruction. DATA SOURCES: For this review we did a comprehensive search of PubMed/MEDLINE from inception to May 31, 2021 for papers with a significant sample size (at least 20 patients enrolled) dealing with EUS-HGS. Data on technical success, clinical success and rate of adverse events were collected. RESULTS: A total of 22 studies with different design, comprising 874 patients, were included. Technical success was achieved in about 96% of cases (ranging from 65% to 100%). Clinical success was obtained in almost 91% of cases (ranging from 76% to 100%). Overall rate of adverse events was 19% (ranging from 0% to 35%). Abdominal pain, self-limiting pneumoperitoneum, bile leak, cholangitis, bleeding, perforation and intraperitoneal migration of the stent were the most common. CONCLUSIONS: Despite both safety and efficacy profile, at the moment HGS still remains a challenging procedure at every single step and must therefore be conducted by a very experienced endoscopist in interventional EUS and ERCP procedures, who is able to deal with the possible severe adverse events of this procedure. A rapid introduction in clinical practice of dedicated devices is desiderable.

Nomogram for prediction of adverse events after lumen-apposing metal stent placement for drainage of pancreatic fluid collections.

OBJECTIVES: To generate a prognostic model based on a nomogram for adverse event (AE) prediction after lumen-apposing metal stents (LAMS) placement in patients with pancreatic fluid collections (PFC). METHODS: Data from a large multicenter series of PFCs treated with LAMS placement were retrieved. AE (overall and excluding mild events) prediction was calculated through a logistic regression model and a nomogram was created and internally validated after bootstrapping. Results were expressed in terms of odds ratio (OR) and 95% confidence interval (CI). Discrimination was assessed by c-statistics and calibrated by comparing deciles of predicted and observed ORs. RESULTS: Overall, 516 patients were included (males 68%, mean age 61.6 ± 15.2 years). PFCs were predominantly walled-off necrosis (52.1%). Independent predictors of AE occurrence were injury of main pancreatic duct (OR in the case of leak 2.51, 95% CI 1.06-5.97, P = 0.03; OR in the case of complete disruption 2.61, 1.53-4.45, P = 0.01), abnormal vessels (OR in the case of perigastric varices 2.90, 1.31-6.42, P = 0.008; OR in the case of pseudoaneurysm 2.99, 1.75-11.93, P = 0.002), using a multigate technique (OR 3.00, 1.28-5.24; P = 0.05), and need of percutaneous drainage (OR 2.81, 1.03-7.65, P = 0.04). By nomogram, a score beyond 200 points corresponded to a 50% probability of AE occurrence. The model was confirmed even when excluding mild AEs and it showed optimal discrimination (c-index 76.8%, 95% CI 74-79), confirmed after internal validation. CONCLUSION: Patients with preprocedural evidence of pancreatic duct leak/disruption, vessel alteration, requiring percutaneous drainage or a multigate technique are at higher risk for AE.