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Background: The diagnostic accuracy of colon capsule endoscopy (CCE) depends on a well-cleansed bowel. Evaluating the cleansing quality can be difficult with a substantial interobserver variation. Objectives: Our primary aim was to establish a standard of agreement for bowel cleansing in CCE based on evaluations by expert readers. Then, we aimed to investigate the interobserver agreement on bowel cleansing. Design: We conducted an interobserver agreement study on bowel cleansing quality. Methods: Readers with different experience levels in CCE and colonoscopy evaluated bowel cleansing quality on the Leighton–Rex scale and Colon Capsule CLEansing Assessment and Report (CC-CLEAR), respectively. All evaluations were reported on an image level. A total of 24 readers rated 500 images on each scale. Results: An expert opinion-based agreement standard could be set for poor and excellent cleansing but not for the spectrum in between, as the experts agreed on only a limited number of images representing fair and good cleansing. The overall interobserver agreement on the Leighton–Rex full scale was good (intraclass correlation coefficient (ICC) 0.84, 95% CI (0.82–0.85)) and remained good when stratified by experience level. On the full CC-CLEAR scale, the overall agreement was moderate (ICC 0.62, 95% CI (0.59–0.65)) and remained so when stratified by experience level. Conclusion: The interobserver agreement was good for the Leighton–Rex scale and moderate for CC-CLEAR, irrespective of the reader’s experience level. It was not possible to establish an expert-opinion standard of agreement for cleansing quality in CCE images. Dedicated training in using the scales may improve agreement and enable future algorithm calibration for artificial intelligence supported cleansing evaluation. Trial registration: All included images were derived from the CAREforCOLON 2015 trial (Registered with The Regional Health Research Ethics Committee (Registration number: S-20190100), the Danish data protection agency (Ref. 19/29858), and ClinicalTrials.gov (registration number: NCT04049357)).

Background: Social inequalities in colorectal cancer screening participation are evident. Barriers to screening participation include discomfort from diagnostic modalities. We aimed to describe the discomfort experienced from colonoscopy and colon capsule endoscopy (CCE) and investigate the discrepancy between expected and experienced discomfort stratified by socioeconomic status. Methods: A randomised controlled trial was conducted offering half of the colorectal cancer screening invitees the choice between CCE and colonoscopy after a positive faecal immunochemical test. This paper includes those who elected to undergo CCE. A positive CCE elicited referral for a therapeutic colonoscopy. Participants reported their discomfort from CCE and from any following colonoscopies in electronically distributed questionnaires. Discomfort was measured using visual analogue scales and compared between socioeconomic subgroups determined by educational level and income. Results: The experienced discomfort from CCE and colonoscopy differed significantly between educational levels but not income levels. The bowel preparation contributed the most to the experienced discomfort in both CCE and colonoscopy. The discrepancy between expected and experienced discomfort from colonoscopy increased with increasing educational and income levels. A similar trend was seen in CCE between educational levels but not income levels. Conclusions: None of the results indicated a higher discomfort in lower socioeconomic subgroups. Regardless of the investigation modality, the bowel preparation was the main contributor to experienced discomfort. The discrepancy between expected and experienced discomfort did not seem to be larger in lower socioeconomic subgroups, indicating that this is not a major barrier causing inequalities in screening uptake. This is the first study investigating individual discomfort discrepancy in both CCE and colonoscopy, while being able to stratify by socioeconomic status.

Introduction Follow-up after an episode of colonic diverticulitis is a common indication for colonoscopy, even though studies have shown a low risk of positive findings in this population. Our objective is to investigate colon capsule endoscopy (CCE) as a follow-up examination in patients with colonic diverticulitis compared with colonoscopy, particularly regarding patient satisfaction and clinical performance.Methods and analysis We will conduct a single-centre prospective randomised controlled trial. Patients seen at Odense University Hospital with acute diverticulitis confirmed by CT will be included and randomised to either follow-up by colonoscopy or CCE. Detection of suspected cancer, more than two polyps or any number of polyps larger than 9 mm in CCE will generate an invitation to a diagnostic colonoscopy for biopsies or polyp removal. We will compare colonoscopy and CCE regarding patient satisfaction and tolerance, the number of complete examinations, the number of patients referred to a subsequent colonoscopy after CCE and the prevalence of diverticula, polyps, cancers and other abnormal findings.Ethics and dissemination Informed consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee (ref. S-20210127) and the Danish Data Protection Agency (ref. 22/43235). After completion of the trial, we plan to publish two articles in high-impact journals. One article on both primary and secondary outcomes.Trial registration number NCT05700981.

Abstract Background Colorectal cancer (CRC) screening reduces all-cause and CRC-related mortality. New research demonstrates that the faecal haemoglobin concentration (f-Hb) may indicate the presence of other serious diseases not related to CRC. We investigated the association between f-Hb, measured by a faecal immunochemical test (FIT), and both all-cause mortality and cause of death in a population-wide cohort of screening participants. Methods Between 2014 and 2018, 1,262,165 participants submitted a FIT for the Danish CRC screening programme. We followed these participants, using the Danish CRC Screening Database and several other national registers on health and population, until December 31, 2018. We stratified participants by f-Hb and compared them using a Cox proportional hazards regression on all-cause mortality and cause of death reported as adjusted hazard ratios (aHRs). We adjusted for several covariates, including comorbidity, socioeconomic factors, demography and prescription medication. Results We observed 21,847 deaths in the study period. Our multivariate analyses indicated an association relationship between increasing f-Hb and the risk of dying in the study period. This risk increased steadily from aHR 1.38 (95% CI: 1.32, 1.44) in those with a f-Hb of 7.1–11.9 μg Hb/g faeces to 2.20 (95% CI: 2.10, 2.30) in those with a f-Hb ≥60.0 μg Hb/g faeces, when compared to those with a f-Hb ≤7.0 μg Hb/g faeces. The pattern remained when excluding CRC from the analysis. Similar patterns were observed between incrementally increasing f-Hb and the risk of dying from respiratory disease, cardiovascular disease and cancers other than CRC. Furthermore, we observed an increased risk of dying from CRC with increasing f-Hb. Conclusions Our findings support the hypothesis that f-Hb may indicate an elevated risk of having chronic conditions if causes for the bleeding have not been identified. The mechanisms still need to be established, but f-Hb may be a potential biomarker for several non-CRC diseases.

Capsule retention is a rare complication to capsule endoscopy. It is often asymptomatic and resolves itself spontaneously. In some cases, endoscopy or surgery is necessary to remove the capsule. Cases of capsule retention in the colon are not reported very often and precautions in subsequent investigations must be considered. We present a case of a 74-year-old woman who underwent colon capsule endoscopy (CCE) due to a positive fecal immunochemical test. The CCE was incomplete, and the patient was referred to conventional colonoscopy, which was complicated by perforation of the large bowel during the procedure. This lead to a CT scan showing the capsule proximal to a stenotic colon segment which was subsequently surgically removed. In patients who report lack of capsule excretion and stenosis is not verified, colonoscopy can be carried out, but with caution.

Colon capsule endoscopy (CCE) has been available for nearly two decades but has grappled with being an equal diagnostic alternative to optical colonoscopy (OC). Due to the COVID-19 pandemic, CCE has gained more foothold in clinical practice. In this cutting-edge review, we aim to present the existing knowledge on the pros and cons of CCE and discuss whether the modality is ready for a larger roll-out in clinical settings. We have included clinical trials and reviews with the most significant impact on the current position of CCE in clinical practice and discuss the challenges that persist and how they could be addressed to make CCE a more sustainable imaging modality with an adenoma detection rate equal to OC and a low re-investigation rate by a proper preselection of suitable populations. CCE is embedded with a very low risk of severe complications and can be performed in the patient’s home as a pain-free procedure. The diagnostic accuracy is found to be equal to OC. However, a significant drawback is low completion rates eliciting a high re-investigation rate. Furthermore, the bowel preparation before CCE is extensive due to the high demand for clean mucosa. CCE is currently not suitable for large-scale implementation in clinical practice mainly due to high re-investigation rates. By a better preselection before CCE and the implantation of artificial intelligence for picture and video analysis, CCE could be the alternative to OC needed to move away from in-hospital services and relieve long-waiting lists for OC.

Colon capsule endoscopy (CCE) is a promising modality for colonic investigations, but completion rates (CR) and adequate cleansing rates (ACR) must be improved to meet established standards for optical colonoscopy. Improvements should be made with patient acceptability in mind. We aimed to compare a very low-volume polyethylene glycol (PEG) laxative to a conventional high-volume laxative. We carried out a single-center retrospective comparative cohort study including patients referred for CCE. One hundred and sixty-six patients were included in the final analysis, with eighty-three patients in each group. We found a CR and ACR of 77% and 67% in the high-volume group and 72% and 75% in the very low-volume group, respectively. In the high-volume group, 54% had complete transit and adequate cleansing, whereas this was the case for 63% in the very low-volume group. No statistically significant difference in CR, ACR, or a combination of the two was found. A very low-volume bowel preparation regimen was non-inferior to a high-volume regimen before CCE in terms of CR and ACR.

Background and study aims The Danish CareForColon2015 trial, launched in 2020 as part of the Danish Colorectal Cancer Screening program, is the largest randomized controlled trial to date on colon capsule endoscopy (CCE). This paper presents the interim analysis with the objective of ensuring the safety of patients in the intervention group and evaluating the clinical performance of the trial’s predefined clinical parameters. Patients and methods We evaluated the initial 234 CCEs according to quality, safety, and completion. The participation rates and preference distribution of all individuals invited were analyzed and sample size calculations were adjusted. Results Fecal immunochemical test and diagnostic participation rates were 62.1 % and 91.1 %, respectively. The completion rate for CCEs was 67.9 % and the rate of conclusive investigations was 80.3 %. The polyp detection rate (PDR) was high (73.5 %), only two (0.85 %) technical failures in 234 videos were observed, and six suspected cancers were identified (2.6 %). No major adverse events were recorded. The required number of invitations had been underestimated due to inaccurate assumptions in sample size calculations. Conclusions The trial was efficient and safe in terms of CCE quality and time to diagnostic investigation. Participation rates and PDRs were high. The proportion of suspected cancers was lower than expected and will be followed. The completion rate for CCEs was acceptable but lower than expected and the CCE procedure was reviewed for potential improvements and Resolor was added to the regime. The number of invitations for the intervention group of the trial has been adjusted from 62,107 to 185,153.

Background and study aims The aim of this study was to introduce EndoConf, a reliable and easy-to-use tool capable of optimizing clinical care in endoscopy by reducing the number of repeat endoscopy procedures, providing continuous on-the-job clinical education, and allowing a smooth transition to the next level of artificial intelligence-supported systems. Patients and methods We prospectively developed and improved a real-time conference system (EndoConf). EndoConf enables endoscopists to contact on-demand and in real time experienced endoscopists across other sites. After the initial introduction period, we registered all EndoConf-assisted procedures from our unit (Surgical Department of Odense University Hospital) over a 3-month period (Autumn of 2019). Results Of 84 EndoConf-supported procedures, 58 were eligible for further analysis. Eventually, 38 calls were made, of which only four were technically of low quality (10.5 %) while three were not answered (7.9 %). Of the 35 (92.1 %) completed EndoConf calls; 24 were referred for endoscopic mucosal resection, six were referred for transanal microsurgery preceded by transrectal ultrasonography and three were referred for multidisciplinary conference, whereas in two cases, the lesion was resected during EndoConf. Conclusions We found the EndoConf system to provide support that could reduce the number of unnecessary repeat endoscopic procedures while at the same time ensuring avoidance of any hazardous attempt at polypectomy.

Semantic segmentation of biomedical images found its niche in screening and diagnostic applications. Recent methods based on deep learning convolutional neural networks have been very effective, since they are readily adaptive to biomedical applications and outperform other competitive segmentation methods. Inspired by the U-Net, we designed a deep learning network with an innovative architecture, hereafter referred to as AID-U-Net. Our network consists of direct contracting and expansive paths, as well as a distinguishing feature of containing sub-contracting and sub-expansive paths. The implementation results on seven totally different databases of medical images demonstrated that our proposed network outperforms the state-of-the-art solutions with no specific pre-trained backbones for both 2D and 3D biomedical image segmentation tasks. Furthermore, we showed that AID-U-Net dramatically reduces time inference and computational complexity in terms of the number of learnable parameters. The results further show that the proposed AID-U-Net can segment different medical objects, achieving an improved 2D F1-score and 3D mean BF-score of 3.82% and 2.99%, respectively.

Completing colon capsule endoscopy (CCE) investigations rely on successful transit and acceptable bowel preparation quality. We investigated the effect of adding castor oil to the CCE bowel preparation regimen on the completion rate using a meta-analysis of existing literature. We conducted a systematic literature search in PubMed, Web of Science, and Embase. Included studies underwent quality assessment, and data for meta-analysis were extracted. Pooled estimates for excretion rate and acceptable bowel preparation rate were calculated. We identified 72 studies matching our search criteria, and six were included in the meta-analysis. Three of the studies had control groups, although two used historical cohorts. The pooled excretion rate (92%) was significantly higher in patients who received castor oil than in those who did not (73%). No significant difference in acceptable colonic cleanliness was observed. Castor oil has been used in a few studies as a booster for CCE. This meta-analysis shows the potential for this medication to improve excretion rates, and castor oil could be actively considered in conjunction with other emerging laxative regimens in CCE. Still, prospective randomized trials with appropriate control groups should be conducted before any conclusions can be drawn. Prospero ID: CRD42022338939.

Video-capsule endoscopy (VCE) reading is a time- and energy-consuming task. Agreement on findings between readers (either different or the same) is a crucial point for increasing performance and providing valid reports. The aim of this systematic review with meta-analysis is to provide an evaluation of inter/intra-observer agreement in VCE reading. A systematic literature search in PubMed, Embase and Web of Science was performed throughout September 2022. The degree of observer agreement, expressed with different test statistics, was extracted. As different statistics are not directly comparable, our analyses were stratified by type of test statistics, dividing them in groups of “None/Poor/Minimal”, “Moderate/Weak/Fair”, “Good/Excellent/Strong” and “Perfect/Almost perfect” to report the proportions of each. In total, 60 studies were included in the analysis, with a total of 579 comparisons. The quality of included studies, assessed with the MINORS score, was sufficient in 52/60 studies. The most common test statistics were the Kappa statistics for categorical outcomes (424 comparisons) and the intra-class correlation coefficient (ICC) for continuous outcomes (73 comparisons). In the overall comparison of inter-observer agreement, only 23% were evaluated as “good” or “perfect”; for intra-observer agreement, this was the case in 36%. Sources of heterogeneity (high, I2 81.8–98.1%) were investigated with meta-regressions, showing a possible role of country, capsule type and year of publication in Kappa inter-observer agreement. VCE reading suffers from substantial heterogeneity and sub-optimal agreement in both inter- and intra-observer evaluation. Artificial-intelligence-based tools and the adoption of a unified terminology may progressively enhance levels of agreement in VCE reading.

Capsule endoscopy (CE) is a valid alternative to conventional gastrointestinal (GI) endoscopy tools. In CE, annotation tools are crucial in developing large and annotated medical image databases for training deep neural networks (DNN). We provide an overview of the described and in-use various annotation systems available, focusing on the annotation of adenomatous polyp pathology in the GI tract. Some studies present promising results regarding time efficiency by implementing automated labelling features in annotation systems. Thus, data are inadequate regarding the general overview for users, and may also be more specific on which features provided are necessary for polyp annotation.

Introduction The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial.Methods and analysis We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas 10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures.Ethics and dissemination All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858).Trial registration details The study has been registered with ClinicalTrials.gov under: NCT04049357.

Prompted by the core idea of wireless capsule endoscopy as a painless gastrointestinal examination, and the easy adoption of small bowel capsule endoscopy, the armamentarium of the capsule-based imaging platforms has grown to include colon capsule devices as well [...]

Colon capsule endoscopy as an alternative to colonoscopy for the diagnosis of colonic disease may serve as a less invasive and more tolerable investigation for patients. Our aim was to examine patient-reported outcomes for colon capsule endoscopy compared to conventional optical colonoscopy including preference of investigation modality, tolerability and adverse events. A systematic literature search was conducted in Web of Science, PubMed and Embase. Search results were thoroughly screened for in- and exclusion criteria. Included studies underwent assessment of transparency and completeness, after which, data for meta-analysis were extracted. Pooled estimates of patient preference were calculated and heterogeneity was examined including univariate meta-regressions. Patient-reported tolerability and adverse events were reviewed. Out of fourteen included studies, twelve had investigated patient-reported outcomes in patients who had undergone both investigations, whereas in two the patients were randomized between investigations. Pooled patient preferences were estimated to be 52% (CI 95%: 41–63%) for colon capsule endoscopy and 45% (CI 95%: 33–57%) for conventional colonoscopy: not indicating a significant difference. Procedural adverse events were rarely reported by patients for either investigation. The tolerability was high for both colon capsule endoscopy and conventional colonoscopy. Patient preferences for conventional colonoscopy and colon capsule endoscopy were not significantly different. Procedural adverse events were rare and the tolerability for colon capsule endoscopy was consistently reported higher or equal to that of conventional colonoscopy.