Consensus statements on the current landscape of artificial intelligence applications in endoscopy, addressing roadblocks, and advancing artificial intelligence in gastroenterology.

BACKGROUND AND AIMS: The American Society for Gastrointestinal Endoscopy (ASGE) AI Task Force along with experts in endoscopy, technology space, regulatory authorities, and other medical subspecialties initiated a consensus process that analyzed the current literature, highlighted potential areas, and outlined the necessary research in artificial intelligence (AI) to allow a clearer understanding of AI as it pertains to endoscopy currently. METHODS: A modified Delphi process was used to develop these consensus statements. RESULTS: Statement 1: Current advances in AI allow for the development of AI-based algorithms that can be applied to endoscopy to augment endoscopist performance in detection and characterization of endoscopic lesions. Statement 2: Computer vision-based algorithms provide opportunities to redefine quality metrics in endoscopy using AI, which can be standardized and can reduce subjectivity in reporting quality metrics. Natural language processing-based algorithms can help with the data abstraction needed for reporting current quality metrics in GI endoscopy effortlessly. Statement 3: AI technologies can support smart endoscopy suites, which may help optimize workflows in the endoscopy suite, including automated documentation. Statement 4: Using AI and machine learning helps in predictive modeling, diagnosis, and prognostication. High-quality data with multidimensionality are needed for risk prediction, prognostication of specific clinical conditions, and their outcomes when using machine learning methods. Statement 5: Big data and cloud-based tools can help advance clinical research in gastroenterology. Multimodal data are key to understanding the maximal extent of the disease state and unlocking treatment options. Statement 6: Understanding how to evaluate AI algorithms in the gastroenterology literature and clinical trials is important for gastroenterologists, trainees, and researchers, and hence education efforts by GI societies are needed. Statement 7: Several challenges regarding integrating AI solutions into the clinical practice of endoscopy exist, including understanding the role of human-AI interaction. Transparency, interpretability, and explainability of AI algorithms play a key role in their clinical adoption in GI endoscopy. Developing appropriate AI governance, data procurement, and tools needed for the AI lifecycle are critical for the successful implementation of AI into clinical practice. Statement 8: For payment of AI in endoscopy, a thorough evaluation of the potential value proposition for AI systems may help guide purchasing decisions in endoscopy. Reliable cost-effectiveness studies to guide reimbursement are needed. Statement 9: Relevant clinical outcomes and performance metrics for AI in gastroenterology are currently not well defined. To improve the quality and interpretability of research in the field, steps need to be taken to define these evidence standards. Statement 10: A balanced view of AI technologies and active collaboration between the medical technology industry, computer scientists, gastroenterologists, and researchers are critical for the meaningful advancement of AI in gastroenterology. CONCLUSIONS: The consensus process led by the ASGE AI Task Force and experts from various disciplines has shed light on the potential of AI in endoscopy and gastroenterology. AI-based algorithms have shown promise in augmenting endoscopist performance, redefining quality metrics, optimizing workflows, and aiding in predictive modeling and diagnosis. However, challenges remain in evaluating AI algorithms, ensuring transparency and interpretability, addressing governance and data procurement, determining payment models, defining relevant clinical outcomes, and fostering collaboration between stakeholders. Addressing these challenges while maintaining a balanced perspective is crucial for the meaningful advancement of AI in gastroenterology.

The New European Medical Device Regulation: Balancing Innovation and Patient Safety.

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New "expert panels" have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous "notified bodies" (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.

Spatio-temporal classification for polyp diagnosis.

Colonoscopy remains the gold standard investigation for colorectal cancer screening as it offers the opportunity to both detect and resect pre-cancerous polyps. Computer-aided polyp characterisation can determine which polyps need polypectomy and recent deep learning-based approaches have shown promising results as clinical decision support tools. Yet polyp appearance during a procedure can vary, making automatic predictions unstable. In this paper, we investigate the use of spatio-temporal information to improve the performance of lesions classification as adenoma or non-adenoma. Two methods are implemented showing an increase in performance and robustness during extensive experiments both on internal and openly available benchmark datasets.

Benefits and challenges in implementation of artificial intelligence in colonoscopy: World Endoscopy Organization position statement.

The number of artificial intelligence (AI) tools for colonoscopy on the market is increasing with supporting clinical evidence. Nevertheless, their implementation is not going smoothly for a variety of reasons, including lack of data on clinical benefits and cost-effectiveness, lack of trustworthy guidelines, uncertain indications, and cost for implementation. To address this issue and better guide practitioners, the World Endoscopy Organization (WEO) has provided its perspective about the status of AI in colonoscopy as the position statement. WEO Position Statement: Statement 1.1: Computer-aided detection (CADe) for colorectal polyps is likely to improve colonoscopy effectiveness by reducing adenoma miss rates and thus increase adenoma detection; Statement 1.2: In the short term, use of CADe is likely to increase health-care costs by detecting more adenomas; Statement 1.3: In the long term, the increased cost by CADe could be balanced by savings in costs related to cancer treatment (surgery, chemotherapy, palliative care) due to CADe-related cancer prevention; Statement 1.4: Health-care delivery systems and authorities should evaluate the cost-effectiveness of CADe to support its use in clinical practice; Statement 2.1: Computer-aided diagnosis (CADx) for diminutive polyps (≤5 mm), when it has sufficient accuracy, is expected to reduce health-care costs by reducing polypectomies, pathological examinations, or both; Statement 2.2: Health-care delivery systems and authorities should evaluate the cost-effectiveness of CADx to support its use in clinical practice; Statement 3: We recommend that a broad range of high-quality cost-effectiveness research should be undertaken to understand whether AI implementation benefits populations and societies in different health-care systems.

Identifying key mechanisms leading to visual recognition errors for missed colorectal polyps using eye-tracking technology.

BACKGROUND AND AIM: Lack of visual recognition of colorectal polyps may lead to interval cancers. The mechanisms contributing to perceptual variation, particularly for subtle and advanced colorectal neoplasia, have scarcely been investigated. We aimed to evaluate visual recognition errors and provide novel mechanistic insights. METHODS: Eleven participants (seven trainees and four medical students) evaluated images from the UCL polyp perception dataset, containing 25 polyps, using eye-tracking equipment. Gaze errors were defined as those where the lesion was not observed according to eye-tracking technology. Cognitive errors occurred when lesions were observed but not recognized as polyps by participants. A video study was also performed including 39 subtle polyps, where polyp recognition performance was compared with a convolutional neural network. RESULTS: Cognitive errors occurred more frequently than gaze errors overall (65.6%), with a significantly higher proportion in trainees (P = 0.0264). In the video validation, the convolutional neural network detected significantly more polyps than trainees and medical students, with per-polyp sensitivities of 79.5%, 30.0%, and 15.4%, respectively. CONCLUSIONS: Cognitive errors were the most common reason for visual recognition errors. The impact of interventions such as artificial intelligence, particularly on different types of perceptual errors, needs further investigation including potential effects on learning curves. To facilitate future research, a publicly accessible visual perception colonoscopy polyp database was created.

Computer-aided characterization of early cancer in Barrett's esophagus on i-scan magnification imaging: a multicenter international study.

BACKGROUND AND AIMS: We aimed to develop a computer-aided characterization system that could support the diagnosis of dysplasia in Barrett's esophagus (BE) on magnification endoscopy. METHODS: Videos were collected in high-definition magnification white-light and virtual chromoendoscopy with i-scan (Pentax Hoya, Japan) imaging in patients with dysplastic and nondysplastic BE (NDBE) from 4 centers. We trained a neural network with a Resnet101 architecture to classify frames as dysplastic or nondysplastic. The network was tested on 3 different scenarios: high-quality still images, all available video frames, and a selected sequence within each video. RESULTS: Fifty-seven patients, each with videos of magnification areas of BE (34 dysplasia, 23 NDBE), were included. Performance was evaluated by a leave-1-patient-out cross-validation method. In all, 60,174 (39,347 dysplasia, 20,827 NDBE) magnification video frames were used to train the network. The testing set included 49,726 i-scan-3/optical enhancement magnification frames. On 350 high-quality still images, the network achieved a sensitivity of 94%, specificity of 86%, and area under the receiver operator curve (AUROC) of 96%. On all 49,726 available video frames, the network achieved a sensitivity of 92%, specificity of 82%, and AUROC of 95%. On a selected sequence of frames per case (total of 11,471 frames), we used an exponentially weighted moving average of classifications on consecutive frames to characterize dysplasia. The network achieved a sensitivity of 92%, specificity of 84%, and AUROC of 96%. The mean assessment speed per frame was 0.0135 seconds (SD ± 0.006). CONCLUSION: Our network can characterize BE dysplasia with high accuracy and speed on high-quality magnification images and sequence of video frames, moving it toward real-time automated diagnosis.

Polyp characterization using deep learning and a publicly accessible polyp video database.

OBJECTIVES: Convolutional neural networks (CNN) for computer-aided diagnosis of polyps are often trained using high-quality still images in a single chromoendoscopy imaging modality with sessile serrated lesions (SSLs) often excluded. This study developed a CNN from videos to classify polyps as adenomatous or nonadenomatous using standard narrow-band imaging (NBI) and NBI-near focus (NBI-NF) and created a publicly accessible polyp video database. METHODS: We trained a CNN with 16,832 high and moderate quality frames from 229 polyp videos (56 SSLs). It was evaluated with 222 polyp videos (36 SSLs) across two test-sets. Test-set I consists of 14,320 frames (157 polyps, 111 diminutive). Test-set II, which is publicly accessible, 3317 video frames (65 polyps, 41 diminutive), which was benchmarked with three expert and three nonexpert endoscopists. RESULTS: Sensitivity for adenoma characterization was 91.6% in test-set I and 89.7% in test-set II. Specificity was 91.9% and 88.5%. Sensitivity for diminutive polyps was 89.9% and 87.5%; specificity 90.5% and 88.2%. In NBI-NF, sensitivity was 89.4% and 89.5%, with a specificity of 94.7% and 83.3%. In NBI, sensitivity was 85.3% and 91.7%, with a specificity of 87.5% and 90.0%, respectively. The CNN achieved preservation and incorporation of valuable endoscopic innovations (PIVI)-1 and PIVI-2 thresholds for each test-set. In the benchmarking of test-set II, the CNN was significantly more accurate than nonexperts (13.8% difference [95% confidence interval 3.2-23.6], P = 0.01) with no significant difference with experts. CONCLUSIONS: A single CNN can differentiate adenomas from SSLs and hyperplastic polyps in both NBI and NBI-NF. A publicly accessible NBI polyp video database was created and benchmarked.

Polyp detection on video colonoscopy using a hybrid 2D/3D CNN.

Colonoscopy is the gold standard for early diagnosis and pre-emptive treatment of colorectal cancer by detecting and removing colonic polyps. Deep learning approaches to polyp detection have shown potential for enhancing polyp detection rates. However, the majority of these systems are developed and evaluated on static images from colonoscopies, whilst in clinical practice the treatment is performed on a real-time video feed. Non-curated video data remains a challenge, as it contains low-quality frames when compared to still, selected images often obtained from diagnostic records. Nevertheless, it also embeds temporal information that can be exploited to increase predictions stability. A hybrid 2D/3D convolutional neural network architecture for polyp segmentation is presented in this paper. The network is used to improve polyp detection by encompassing spatial and temporal correlation of the predictions while preserving real-time detections. Extensive experiments show that the hybrid method outperforms a 2D baseline. The proposed architecture is validated on videos from 46 patients and on the publicly available SUN polyp database. A higher performance and increased generalisability indicate that real-world clinical implementations of automated polyp detection can benefit from the hybrid algorithm and the inclusion of temporal information.

Expected value of artificial intelligence in gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

This ESGE Position Statement defines the expected value of artificial intelligence (AI) for the diagnosis and management of gastrointestinal neoplasia within the framework of the performance measures already defined by ESGE. This is based on the clinical relevance of the expected task and the preliminary evidence regarding artificial intelligence in artificial or clinical settings. MAIN RECOMMENDATIONS:: (1) For acceptance of AI in assessment of completeness of upper GI endoscopy, the adequate level of mucosal inspection with AI should be comparable to that assessed by experienced endoscopists. (2) For acceptance of AI in assessment of completeness of upper GI endoscopy, automated recognition and photodocumentation of relevant anatomical landmarks should be obtained in ≥90% of the procedures. (3) For acceptance of AI in the detection of Barrett's high grade intraepithelial neoplasia or cancer, the AI-assisted detection rate for suspicious lesions for targeted biopsies should be comparable to that of experienced endoscopists with or without advanced imaging techniques. (4) For acceptance of AI in the management of Barrett's neoplasia, AI-assisted selection of lesions amenable to endoscopic resection should be comparable to that of experienced endoscopists. (5) For acceptance of AI in the diagnosis of gastric precancerous conditions, AI-assisted diagnosis of atrophy and intestinal metaplasia should be comparable to that provided by the established biopsy protocol, including the estimation of extent, and consequent allocation to the correct endoscopic surveillance interval. (6) For acceptance of artificial intelligence for automated lesion detection in small-bowel capsule endoscopy (SBCE), the performance of AI-assisted reading should be comparable to that of experienced endoscopists for lesion detection, without increasing but possibly reducing the reading time of the operator. (7) For acceptance of AI in the detection of colorectal polyps, the AI-assisted adenoma detection rate should be comparable to that of experienced endoscopists. (8) For acceptance of AI optical diagnosis (computer-aided diagnosis [CADx]) of diminutive polyps (≤5 mm), AI-assisted characterization should match performance standards for implementing resect-and-discard and diagnose-and-leave strategies. (9) For acceptance of AI in the management of polyps ≥ 6 mm, AI-assisted characterization should be comparable to that of experienced endoscopists in selecting lesions amenable to endoscopic resection.

Survey on the perceptions of UK gastroenterologists and endoscopists to artificial intelligence.

Background and aims: With the potential integration of artificial intelligence (AI) into clinical practice, it is essential to understand end users' perception of this novel technology. The aim of this study, which was endorsed by the British Society of Gastroenterology (BSG), was to evaluate the UK gastroenterology and endoscopy communities' views on AI. Methods: An online survey was developed and disseminated to gastroenterologists and endoscopists across the UK. Results: One hundred four participants completed the survey. Quality improvement in endoscopy (97%) and better endoscopic diagnosis (92%) were perceived as the most beneficial applications of AI to clinical practice. The most significant challenges were accountability for incorrect diagnoses (85%) and potential bias of algorithms (82%). A lack of guidelines (92%) was identified as the greatest barrier to adopting AI in routine clinical practice. Participants identified real-time endoscopic image diagnosis (95%) as a research priority for AI, while the most perceived significant barriers to AI research were funding (82%) and the availability of annotated data (76%). Participants consider the priorities for the BSG AI Task Force to be identifying research priorities (96%), guidelines for adopting AI devices in clinical practice (93%) and supporting the delivery of multicentre clinical trials (91%). Conclusion: This survey has identified views from the UK gastroenterology and endoscopy community regarding AI in clinical practice and research, and identified priorities for the newly formed BSG AI Task Force.

A new artificial intelligence system successfully detects and localises early neoplasia in Barrett's esophagus by using convolutional neural networks.

BACKGROUND AND AIMS: Seattle protocol biopsies for Barrett's Esophagus (BE) surveillance are labour intensive with low compliance. Dysplasia detection rates vary, leading to missed lesions. This can potentially be offset with computer aided detection. We have developed convolutional neural networks (CNNs) to identify areas of dysplasia and where to target biopsy. METHODS: 119 Videos were collected in high-definition white light and optical chromoendoscopy with i-scan (Pentax Hoya, Japan) imaging in patients with dysplastic and non-dysplastic BE (NDBE). We trained an indirectly supervised CNN to classify images as dysplastic/non-dysplastic using whole video annotations to minimise selection bias and maximise accuracy. The CNN was trained using 148,936 video frames (31 dysplastic patients, 31 NDBE, two normal esophagus), validated on 25,161 images from 11 patient videos and tested on 264 iscan-1 images from 28 dysplastic and 16 NDBE patients which included expert delineations. To localise targeted biopsies/delineations, a second directly supervised CNN was generated based on expert delineations of 94 dysplastic images from 30 patients. This was tested on 86 i-scan one images from 28 dysplastic patients. FINDINGS: The indirectly supervised CNN achieved a per image sensitivity in the test set of 91%, specificity 79%, area under receiver operator curve of 93% to detect dysplasia. Per-lesion sensitivity was 100%. Mean assessment speed was 48 frames per second (fps). 97% of targeted biopsy predictions matched expert and histological assessment at 56 fps. The artificial intelligence system performed better than six endoscopists. INTERPRETATION: Our CNNs classify and localise dysplastic Barrett's Esophagus potentially supporting endoscopists during surveillance.

Performance of artificial intelligence for detection of subtle and advanced colorectal neoplasia.

OBJECTIVES: There is uncertainty regarding the efficacy of artificial intelligence (AI) software to detect advanced subtle neoplasia, particularly flat lesions and sessile serrated lesions (SSLs), due to low prevalence in testing datasets and prospective trials. This has been highlighted as a top research priority for the field. METHODS: An AI algorithm was evaluated on four video test datasets containing 173 polyps (35,114 polyp-positive frames and 634,988 polyp-negative frames) specifically enriched with flat lesions and SSLs, including a challenging dataset containing subtle advanced neoplasia. The challenging dataset was also evaluated by eight endoscopists (four independent, four trainees, according to the Joint Advisory Group on gastrointestinal endoscopy [JAG] standards in the UK). RESULTS: In the first two video datasets, the algorithm achieved per-polyp sensitivities of 100% and 98.9%. Per-frame sensitivities were 84.1% and 85.2%. In the subtle dataset, the algorithm detected a significantly higher number of polyps (P < 0.0001), compared to JAG-independent and trainee endoscopists, achieving per-polyp sensitivities of 79.5%, 37.2% and 11.5%, respectively. Furthermore, when considering subtle polyps detected by both the algorithm and at least one endoscopist, the AI detected polyps significantly faster on average. CONCLUSIONS: The AI based algorithm achieved high per-polyp sensitivities for advanced colorectal neoplasia, including flat lesions and SSLs, outperforming both JAG independent and trainees on a very challenging dataset containing subtle lesions that could have been overlooked easily and contribute to interval colorectal cancer. Further prospective trials should evaluate AI to detect subtle advanced neoplasia in higher risk populations for colorectal cancer.

Artificial intelligence in biliopancreatic endoscopy: Is there any role?

Artificial intelligence (AI) research in endoscopy is being translated at rapid pace with a number of approved devices now available for use in luminal endoscopy. However, the published literature for AI in biliopancreatic endoscopy is predominantly limited to early pre-clinical studies including applications for diagnostic EUS and patient risk stratification. Potential future use cases are highlighted in this manuscript including optical characterisation of strictures during cholangioscopy, prediction of post-ERCP acute pancreatitis and selective biliary duct cannulation difficulty, automated report generation and novel AI-based quality key performance metrics. To realise the full potential of AI and accelerate innovation, it is crucial that robust inter-disciplinary collaborations are formed between biliopancreatic endoscopists and AI researchers.

Establishing key research questions for the implementation of artificial intelligence in colonoscopy: a modified Delphi method.

BACKGROUND : Artificial intelligence (AI) research in colonoscopy is progressing rapidly but widespread clinical implementation is not yet a reality. We aimed to identify the top implementation research priorities. METHODS : An established modified Delphi approach for research priority setting was used. Fifteen international experts, including endoscopists and translational computer scientists/engineers, from nine countries participated in an online survey over 9 months. Questions related to AI implementation in colonoscopy were generated as a long-list in the first round, and then scored in two subsequent rounds to identify the top 10 research questions. RESULTS : The top 10 ranked questions were categorized into five themes. Theme 1: clinical trial design/end points (4 questions), related to optimum trial designs for polyp detection and characterization, determining the optimal end points for evaluation of AI, and demonstrating impact on interval cancer rates. Theme 2: technological developments (3 questions), including improving detection of more challenging and advanced lesions, reduction of false-positive rates, and minimizing latency. Theme 3: clinical adoption/integration (1 question), concerning the effective combination of detection and characterization into one workflow. Theme 4: data access/annotation (1 question), concerning more efficient or automated data annotation methods to reduce the burden on human experts. Theme 5: regulatory approval (1 question), related to making regulatory approval processes more efficient. CONCLUSIONS : This is the first reported international research priority setting exercise for AI in colonoscopy. The study findings should be used as a framework to guide future research with key stakeholders to accelerate the clinical implementation of AI in endoscopy.

Overview of microscopic colitis.

Microscopic colitis encompasses both collagenous and lymphocytic colitis and is a relatively common condition with rising incidence. Diagnosis is by colonoscopy (which is usually normal but may show some mild changes) and biopsies which reveal characteristic histological findings. Symptoms include non-bloody diarrhoea with urgency which may be associated with faecal incontinence and abdominal pain. Microscopic colitis is associated with a reduced health-related quality of life, and treatment is aimed at symptom control. Medications linked with the development of microscopic colitis, including proton pump inhibitors, non-steroidal anti-inflammatory drugs and selective serotonin-reuptake inhibitors, should be discontinued. If symptoms persist, budesonide is a licensed treatment for microscopic colitis which has been shown to be effective in clinical trials and real-world practice.

Deep learning-based anatomical site classification for upper gastrointestinal endoscopy.

PURPOSE: Upper gastrointestinal (GI) endoscopic image documentation has provided an efficient, low-cost solution to address quality control for endoscopic reporting. The problem is, however, challenging for computer-assisted techniques, because different sites have similar appearances. Additionally, across different patients, site appearance variation may be large and inconsistent. Therefore, according to the British and modified Japanese guidelines, we propose a set of oesophagogastroduodenoscopy (EGD) images to be routinely captured and evaluate its efficiency for deep learning-based classification methods. METHODS: A novel EGD image dataset standardising upper GI endoscopy to several steps is established following landmarks proposed in guidelines and annotated by an expert clinician. To demonstrate the discrimination of proposed landmarks that enable the generation of an automated endoscopic report, we train several deep learning-based classification models utilising the well-annotated images. RESULTS: We report results for a clinical dataset composed of 211 patients (comprising a total of 3704 EGD images) acquired during routine upper GI endoscopic examinations. We find close agreement between predicted labels using our method and the ground truth labelled by human experts. We observe the limitation of current static image classification scheme for EGD image classification. CONCLUSION: Our study presents a framework for developing automated EGD reports using deep learning. We demonstrate that our method is feasible to address EGD image classification and can lead towards improved performance and additionally qualitatively demonstrate its performance on our dataset.