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.

Evaluation of the Potential Utility of an Artificial Intelligence Chatbot in Gastroesophageal Reflux Disease Management.

INTRODUCTION: Artificial intelligence chatbots could serve as an information resource for patients and a tool for clinicians. Their ability to respond appropriately to questions regarding gastroesophageal reflux disease is unknown. METHODS: Twenty-three prompts regarding gastroesophageal reflux disease management were submitted to ChatGPT, and responses were rated by 3 gastroenterologists and 8 patients. RESULTS: ChatGPT provided largely appropriate responses (91.3%), although with some inappropriateness (8.7%) and inconsistency. Most responses (78.3%) contained at least some specific guidance. Patients considered this a useful tool (100%). DISCUSSION: ChatGPT's performance demonstrates the potential for this technology in health care, although also its limitations in its current state.

Steroid Use and Risk of Nonalcoholic Fatty Liver Disease in Patients With Inflammatory Bowel Disease: Systematic Review and Meta-analysis.

GOALS: We sought to evaluate the association of steroids with nonalcoholic fatty liver disease (NAFLD) among patients with inflammatory bowel disease (IBD). BACKGROUND: Patients with IBD are at increased risk of NAFLD. Steroids may have a role in the pathogenesis of NAFLD. STUDY: We searched MEDLINE (through PubMed) and Embase for studies from inception to July 2021. We included published interventional and observational studies of adults 18 years or older with ulcerative colitis or Crohn's disease. We reported odds ratios, 95% confidence intervals, and generated forest plots. A random effects model generated a summary effect estimate. Publication bias was assessed by funnel plot and Egger's test. Study quality was examined using modified Newcastle-Ottawa scale (NOS) and Agency for Healthcare Research and Quality (AHRQ). RESULTS: A total of 12 observational studies with 3497 participants were included. NAFLD was identified in 1017 (29.1%) patients. The pooled odds ratio for the development of NAFLD in steroid users versus non-users was 0.87 (95% confidence interval: 0.72-1.04). There was no significant heterogeneity between studies ( I ²=0.00%, P =0.13). No publication bias was detected by funnel plot or Egger's test ( P =0.24). Findings were consistent among subgroup analyses stratified by study quality. CONCLUSION: In this meta-analysis, steroids were not associated with NAFLD in patients with IBD. Steroids may not need to be withheld from patients with IBD for the purposes of preventing NAFLD. Additional prospective studies that systematically document steroid exposure and important confounders among patients with IBD are warranted.

Speedometer for withdrawal time monitoring during colonoscopy: a clinical implementation trial.

OBJECTIVES: Meticulous inspection of the mucosa during colonoscopy, represents a lengthier withdrawal time, but has been shown to increase adenoma detection rate (ADR). We investigated if artificial intelligence-aided speed monitoring can improve suboptimal withdrawal time. METHODS: We evaluated the implementation of a computer-aided speed monitoring device during colonoscopy at a large academic endoscopy center. After informed consent, patients ≥18 years undergoing colonoscopy between 5 March and 29 April 2021 were examined without the use of the speedometer, and with the speedometer between 29 April and 30 June 2021. All colonoscopies were recorded, and withdrawal time was assessed based on the recordings in a blinded fashion. We compared mean withdrawal time, percentage of withdrawal time ≥6 min, and ADR with and without the speedometer. RESULTS: One hundred sixty-six patients in each group were eligible for analyses. Mean withdrawal time was 9 min and 6.6 s (95% CI: 8 min and 34.8 s to 9 min and 39 s) without the use of the speedometer, and 9 min and 9 s (95% CI: 8 min and 45 s to 9 min and 33.6 s) with the speedometer; difference 2.3 s (95% CI: -42.3-37.7, p = 0.91). The ADRs were 45.2% (95% CI: 37.6-52.8) without the speedometer as compared to 45.8% (95% CI: 38.2-53.4) with the speedometer (p = 0.91). The proportion of colonoscopies with withdrawal time ≥6 min without the speedometer was 85.5% (95% CI: 80.2-90.9) versus 86.7% (95% CI: 81.6-91.9) with the speedometer (p = 0.75). CONCLUSIONS: Use of speed monitoring during withdrawal did not increase withdrawal time or ADR in colonoscopy. CLINICALTRIALS.GOV IDENTIFIER: NCT04710251.

Association Between Opioid Use and Outpatient Visits for Dysphagia: An Analysis of the National Ambulatory Medical Care Survey in 2008-2018.

INTRODUCTION: Opioid-induced esophageal dysfunction has been described with characteristic manometric patterns, but the population burden of dysphagia attributable to opioid use remains unclear. METHODS: The National Ambulatory Medical Care Survey from 2008 to 2018 was used to assess the relationship between opioid use and outpatient visits for dysphagia. RESULTS: After controlling for potential confounders, there were no significant difference in ambulatory visits for dysphagia between opioid users and nonusers (adjusted odds ratio = 0.98, confidence interval: 0.59-1.65). DISCUSSION: No correlation between opioid use and ambulatory visits for dysphagia was found in a nationwide sample. Opioid-related manometric changes may be clinically relevant only in a small proportion of patients.

Examining the Nocebo Effect in Trials of Neuromodulators for Use in Disorders of Gut-Brain Interaction.

INTRODUCTION: Nocebo effects are believed to influence the rate of reported adverse events (AE) and subject withdrawal in both the treatment and placebo groups of randomized clinical trials (RCT). Neuromodulators are commonly prescribed to treat disorders of gut-brain interaction (DGBI), but adherence to these medications is often limited by side effects such as headache, dry mouth, fatigue, and altered bowel habits. We performed a systematic review and meta-analysis to assess the proportion and risk difference of patients who experienced side effects leading to withdrawal in the placebo arm vs the treatment arm of RCT of neuromodulators for DGBI. We also sought to estimate the risk of developing any AE in the placebo arm of these studies and the rate of specific individual AEs. METHODS: We searched MEDLINE, Embase, Web of Science Core Collection, and the Cochrane Central Register of Controlled Trials Searches to identify RCT that included terms for DGBI and for commonly prescribed neuromodulators. We calculated pooled proportions of patients experiencing an AE leading to withdrawal in the active treatment group vs the placebo group with 95% confidence intervals (CI), the pooled proportions of patients experiencing any AE, the pooled proportions of patients experiencing specific AE such as dizziness and headache, the pooled proportions of patients experiencing severe AE, and corresponding pooled risk differences with 95% CI. RESULTS: There were 30 RCT included representing 2,284 patients with DGBI. Twenty-seven RCT reported data on AE leading to withdrawal. The pooled proportion of total patients with AE leading to withdrawal in the placebo group was 4% (95% CI 0.02-0.04). The pooled proportion of patients with AE leading to withdrawal who received neuromodulators was 9% (95% CI 0.06-0.13). In the 12 studies reporting data on patients experiencing at least 1 AE, the pooled proportion of patients experiencing any AE in the placebo group was 18% (95% CI 0.08-0.30), compared with 43% (95% CI 0.24-0.63) in the neuromodulator group. Thus, approximately 44% of the rate of withdrawal (0.04/0.09) and 42% of the rate reporting any side effects (0.18/0.43) in the neuromodulator group may be attributed to nocebo effects in the right context. Subgroup analysis by sex, medication class, risk of bias, and specific DGBI revealed differing withdrawal rates. There was no statistically significant difference in patients experiencing individual AE of dizziness, headache, or diarrhea. Rates of dry mouth, fatigue, and constipation were higher in treatment groups compared with those in placebo groups. DISCUSSION: Patients with DGBI in RCT randomized to placebo groups frequently experience AE and AE that lead to withdrawal consistent with a strong nocebo effect. Nonspecific AE such as dizziness, headaches, and diarrhea occurred similarly in patients receiving placebo compared with those receiving neuromodulators.

Impact of Artificial Intelligence on Colonoscopy Surveillance After Polyp Removal: A Pooled Analysis of Randomized Trials.

BACKGROUND AND AIMS: Artificial intelligence (AI) tools aimed at improving polyp detection have been shown to increase the adenoma detection rate during colonoscopy. However, it is unknown how increased polyp detection rates by AI affect the burden of patient surveillance after polyp removal. METHODS: We conducted a pooled analysis of 9 randomized controlled trials (5 in China, 2 in Italy, 1 in Japan, and 1 in the United States) comparing colonoscopy with or without AI detection aids. The primary outcome was the proportion of patients recommended to undergo intensive surveillance (ie, 3-year interval). We analyzed intervals for AI and non-AI colonoscopies for the U.S. and European recommendations separately. We estimated proportions by calculating relative risks using the Mantel-Haenszel method. RESULTS: A total of 5796 patients (51% male, mean 53 years of age) were included; 2894 underwent AI-assisted colonoscopy and 2902 non-AI colonoscopy. When following U.S. guidelines, the proportion of patients recommended intensive surveillance increased from 8.4% (95% CI, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group (absolute difference, 2.9% [95% CI, 1.4%-4.4%]; risk ratio, 1.35 [95% CI, 1.16-1.57]). When following European guidelines, it increased from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%) (absolute difference, 1.3% [95% CI, 0.01%-2.6%]; risk ratio, 1.22 [95% CI, 1.01-1.47]). CONCLUSIONS: The use of AI during colonoscopy increased the proportion of patients requiring intensive colonoscopy surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs.

Scoping out the future: The application of artificial intelligence to gastrointestinal endoscopy.

Artificial intelligence (AI) is a quickly expanding field in gastrointestinal endoscopy. Although there are a myriad of applications of AI ranging from identification of bleeding to predicting outcomes in patients with inflammatory bowel disease, a great deal of research has focused on the identification and classification of gastrointestinal malignancies. Several of the initial randomized, prospective trials utilizing AI in clinical medicine have centered on polyp detection during screening colonoscopy. In addition to work focused on colorectal cancer, AI systems have also been applied to gastric, esophageal, pancreatic, and liver cancers. Despite promising results in initial studies, the generalizability of most of these AI systems have not yet been evaluated. In this article we review recent developments in the field of AI applied to gastrointestinal oncology.

Charting a path forward for clinical research in artificial intelligence and gastroenterology.

Gastroenterology has been an early leader in bridging the gap between artificial intelligence (AI) model development and clinical trial validation, and in recent years we have seen the publication of several randomized clinical trials examining the role of AI in gastroenterology. As AI applications for clinical medicine advance rapidly, there is a clear need for guidance surrounding AI-specific study design, evaluation, comparison, analysis and reporting of results. Several initiatives are in the publication or pre-publication phase including AI-specific amendments to minimum reporting guidelines for clinical trials, society task force initiatives aimed at priority use cases and research priorities, and minimum reporting guidelines that guide the reporting of clinical prediction models. In this paper, we examine applications of AI in clinical trials and discuss elements of newly published AI-specific extensions to the Consolidated Standards of Reporting Trials and Standard Protocol Items: Recommendations for Interventional Trials statements that guide clinical trial reporting and development. We then review AI applications at the pre-trial level in both endoscopy and other subfields of gastroenterology and explore areas where further guidance is needed to supplement the current guidance available at the pre-trial level.

Deep Learning Computer-aided Polyp Detection Reduces Adenoma Miss Rate: A United States Multi-center Randomized Tandem Colonoscopy Study (CADeT-CS Trial).

BACKGROUND & AIMS: Artificial intelligence-based computer-aided polyp detection (CADe) systems are intended to address the issue of missed polyps during colonoscopy. The effect of CADe during screening and surveillance colonoscopy has not previously been studied in a United States (U.S.) population. METHODS: We conducted a prospective, multi-center, single-blind randomized tandem colonoscopy study to evaluate a deep-learning based CADe system (EndoScreener, Shanghai Wision AI, China). Patients were enrolled across 4 U.S. academic medical centers from 2019 through 2020. Patients presenting for colorectal cancer screening or surveillance were randomized to CADe colonoscopy first or high-definition white light (HDWL) colonoscopy first, followed immediately by the other procedure in tandem fashion by the same endoscopist. The primary outcome was adenoma miss rate (AMR), and secondary outcomes included sessile serrated lesion (SSL) miss rate and adenomas per colonoscopy (APC). RESULTS: A total of 232 patients entered the study, with 116 patients randomized to undergo CADe colonoscopy first and 116 patients randomized to undergo HDWL colonoscopy first. After the exclusion of 9 patients, the study cohort included 223 patients. AMR was lower in the CADe-first group compared with the HDWL-first group (20.12% [34/169] vs 31.25% [45/144]; odds ratio [OR], 1.8048; 95% confidence interval [CI], 1.0780-3.0217; P = .0247). SSL miss rate was lower in the CADe-first group (7.14% [1/14]) vs the HDWL-first group (42.11% [8/19]; P = .0482). First-pass APC was higher in the CADe-first group (1.19 [standard deviation (SD), 2.03] vs 0.90 [SD, 1.55]; P = .0323). First-pass ADR was 50.44% in the CADe-first group and 43.64 % in the HDWL-first group (P = .3091). CONCLUSION: In this U.S. multicenter tandem colonoscopy randomized controlled trial, we demonstrate a decrease in AMR and SSL miss rate and an increase in first-pass APC with the use of a CADe-system when compared with HDWL colonoscopy alone.

Adoption of New Technologies: Artificial Intelligence.

Over the past decade, artificial intelligence (AI) has been broadly applied to many aspects of human life, with recent groundbreaking successes in facial recognition, natural language processing, autonomous driving, and medical imaging. Gastroenterology has applied AI to a vast array of clinical problems, and some of the earliest prospective trials examining AI in medicine have been in computer vision applied to endoscopy. Evidence is mounting for 2 broad areas of AI as applied to gastroenterology: computer-aided detection and computer-aided diagnosis.

Preloaded 22-gauge fine-needle system facilitates placement of a higher number of fiducials for image-guided radiation therapy compared with traditional backloaded 19-gauge approach.

BACKGROUND AND AIMS: Image-guided radiation therapy (IGRT) often relies on EUS-guided fiducial markers. Previously used manually backloaded fiducial needles have multiple potential limitations including safety and efficiency concerns. Our aim was to evaluate the efficacy, feasibility, and safety of EUS-guided placement of gold fiducials using a novel preloaded 22-gauge needle compared with a traditional, backloaded 19-gauge needle. METHODS: This was a single-center comparative cohort study. Patients with pancreatic and hepatobiliary malignancy who underwent EUS-guided fiducial placement (EUS-FP) between October 2014 and February 2018 were included. The main outcome was the technical success of fiducial placement. Secondary outcomes were mean procedure time, fiducial visibility during IGRT, technical success of IGRT delivery, and adverse events. RESULTS: One hundred fourteen patients underwent EUS-FP during the study period. Of these, 111 patients had successful placement of a minimum of 2 fiducials. Fifty-six patients underwent placement using a backloaded 19-gauge needle and 58 patients underwent placement using a 22-gauge preloaded needle. The mean number of fiducials placed successfully at the target site was significantly higher in the 22-gauge group compared with the 19-gauge group (3.53 ± .96 vs 3.11 ± .61, respectively; P = .006). In the 22-gauge group, the clinical goal of placing 4 fiducials was achieved in 78%, compared with 23% in the 19-gauge group (P < .001). In univariate analyses, gender, age, procedure time, tumor size, and location did not influence the number of successfully placed fiducials. Technical success of IGRT with fiducial tracking was high in both the 19-gauge (51/56, 91%) and the 22-gauge group (47/58, 81%; P = .12). CONCLUSIONS: EUS-FP using a preloaded 22-gauge needle is feasible, effective, and safe and allows for a higher number of fiducials placed when compared with the traditional backloaded 19-gauge needle.

Benchmarking definitions of false-positive alerts during computer-aided polyp detection in colonoscopy.

BACKGROUND: The occurrence of false-positive alerts is an important outcome measure in computer-aided colon polyp detection (CADe) studies. However, there is no consensus definition of a false positive in clinical trials evaluating CADe in colonoscopy. We aimed to study the diagnostic performance of CADe based on different threshold definitions for false-positive alerts. METHODS: A previously validated CADe system was applied to screening/surveillance colonoscopy videos. Different thresholds for false-positive alerts were defined based on the time an alert box was continuously traced by the system. Primary outcomes were false-positive results and specificity using different threshold definitions of false positive. RESULTS: 62 colonoscopies were analyzed. CADe specificity and accuracy were 93.2 % and 97.8 %, respectively, for a threshold definition of ≥ 0.5 seconds, 98.6 % and 99.5 % for a threshold definition of ≥ 1 second, and 99.8 % and 99.9 % for a threshold definition of ≥ 2 seconds. CONCLUSION: Our analysis demonstrated how different threshold definitions of false positive can impact the reported diagnostic performance of CADe for colon polyp detection.

Training a computer-aided polyp detection system to detect sessile serrated adenomas using public domain colonoscopy videos.

Background Colorectal cancer (CRC) is a major public health burden worldwide, and colonoscopy is the most commonly used CRC screening tool. Still, there is variability in adenoma detection rate (ADR) among endoscopists. Recent studies have reported improved ADR using deep learning models trained on videos curated largely from private in-house datasets. Few have focused on the detection of sessile serrated adenomas (SSAs), which are the most challenging target clinically. Methods We identified 23 colonoscopy videos available in the public domain and for which pathology data were provided, totaling 390 minutes of footage. Expert endoscopists annotated segments of video with adenomatous polyps, from which we captured 509 polyp-positive and 6,875 polyp-free frames. Via data augmentation, we generated 15,270 adenomatous polyp-positive images, of which 2,310 were SSAs, and 20,625 polyp-negative images. We used the CNN AlexNet and fine-tuned its parameters using 90 % of the images, before testing its performance on the remaining 10 % of images unseen by the model. Results We trained the model on 32,305 images and tested performance on 3,590 images with the same proportion of SSA, non-SSA polyp-positive, and polyp-negative images. The overall accuracy of the model was 0.86, with a sensitivity of 0.73 and a specificity of 0.96. Positive predictive value was 0.93 and negative predictive value was 0.96. The area under the curve was 0.94. SSAs were detected in 93 % of SSA-positive images. Conclusions Using a relatively small set of publicly-available colonoscopy data, we obtained sizable training and validation sets of endoscopic images using data augmentation, and achieved an excellent performance in adenomatous polyp detection.

Regulatory considerations for artificial intelligence technologies in GI endoscopy.

Artificial intelligence (AI) technologies in clinical medicine have become the subject of intensive investigative efforts and popular attention. In domains ranging from pathology to radiology, AI has demonstrated the potential to improve clinical performance and efficiency. In gastroenterology, AI has been applied on multiple fronts, with particular progress seen in the areas of computer-aided polyp detection (CADe) and computer-aided polyp diagnosis (CADx), to assist gastroenterologists during colonoscopy. As clinical evidence accrues for CADe and CADx, our attention must also turn toward the unique challenges that this new wave of technologies represent for the U.S. Food and Drug Administration and other regulatory agencies, who are tasked with protecting public health by ensuring the safety of medical devices. In this review, we describe the current regulatory pathways for AI tools in gastroenterology and the expected evolution of these pathways.