Michael Bretthauer

Meta-analyses of randomized trials have shown that sigmoidoscopy screening reduces colorectal cancer (CRC) incidence and death for 15 years. To report the benefits of sigmoidoscopy after 23 years. Randomized controlled trial. (NORCCAP [Norwegian Colorectal Cancer Prevention], ClinicalTrials.gov: NCT00119912). Population of Oslo and Telemark County, Norway. Persons aged 50 to 64 years without CRC at randomization. Screening with once-only sigmoidoscopy, with or without 1 fecal immunochemical test, or no screening. Colorectal cancer incidence and death. A total of 100 210 persons were randomly assigned, and 98 654 were included in intention-to-screen analyses: 20 552 in the screening group and 78 102 in the no-screening group. Participation with screening was 61.4% in men and 64.7% in women. In men, the 23-year cumulative risk for CRC was 4.3% in the screening group and 6.0% in the no-screening group, corresponding to a risk difference of -1.7 percentage points (95% CI, -2.2 to -1.2 percentage points). In women, the corresponding risks were 4.2% and 4.7%, yielding a risk difference of -0.5 percentage points (CI, -1.0 to -0.01 percentage points). In men, the 23-year cumulative risk for CRC death was 1.4% in the screening group and 2.2% in the no-screening group, corresponding to a risk difference of -0.8 percentage points (CI, -1.1 to -0.5 percentage points). In women, the corresponding risks were 1.3% and 1.4%, yielding a risk difference of -0.1 percentage points (CI, -0.3 to 0.1 percentage points). The effect was strongest for rectosigmoid cancer. The addition of fecal blood testing to sigmoidoscopy did not change screening benefits. Follow-up through national registries. Offering sigmoidoscopy screening in Norway reduced CRC incidence more in men than in women and reduced CRC death only in men. Norwegian government and Norwegian Cancer Society.

The OperA (Optimising Colorectal Cancer Prevention through Personalized Treatment with Artificial Intelligence) project aims to transform colorectal cancer care through artificial intelligence (AI) innovations. Recognizing that legal and ethical challenges remain key obstacles to clinical integration, this Delphi study sought to identify and prioritize such concerns in the context of gastrointestinal (GI) endoscopy. Fourteen international experts participated in a 2-round Delphi process. In round 1, the steering committee, with feedback from participants, proposed legal and ethical issues pertaining to AI in endoscopy. Round 2 involved iterative rating and refinement of these issues to achieve consensus on their importance. Consensus was reached on 10 key statements spanning 3 thematic domains: data governance, medicolegal implications, and equity and bias. Experts emphasized the need for robust data protection, transparent algorithmic development, and institutional clarity on data ownership. Liability concerns related to AI-assisted diagnosis and automated reporting were highlighted, alongside calls for guidance from legal and professional bodies. Finally, participants underscored the importance of demographic diversity in training data sets and transparent reporting practices to mitigate bias and ensure equitable AI deployment. As AI tools become increasingly integrated into the clinical practice of gastroenterology, addressing legal, ethical, and equity-related challenges is essential. This expert consensus provides a foundation for developing guidelines and regulatory frameworks to support responsible AI adoption in GI endoscopy.

Objectives: Accurate identification of adverse events after colonoscopy is essential for quality assurance in colorectal cancer (CRC) screening. Review of medical records is labour intensive as adverse events are infrequent. The object of this study was to investigate the accuracy of claims data in identifying adverse events after colonoscopy in CRC screening. Design: Cross-sectional, retrospective. Setting and participants: Males and females aged 50–74 years were randomised to once-only sigmoidoscopy or biennial faecal immunochemical test in a CRC screening trial at two screening centres in Norway. Participants in the present study underwent follow-up colonoscopy from 2012 to April 2020 after initial positive screening test. We reviewed medical records for adverse events within 30 days following 11 205 colonoscopies. Primary and secondary outcome measures: The primary outcome of the study was to assess the sensitivity of claims data from the Norwegian Patient Registry to identify lower gastrointestinal bleeding using emergency contact International Statistical Classification of Diseases and Related Health Problems 10th Revision diagnostic code sets under two definitions: a stringent definition (codes explicitly identifying bleeding) and a broad definition (including suggestive codes). Secondary outcome measures included the sensitivity to identify perforation using a stringent and a broad definition. Additionally, we assessed whether incorporating procedure codes and non-emergency contacts improved accuracy. Results: 87 cases of lower gastrointestinal bleeding and eight perforations were confirmed. Sensitivity for bleeding differed between the centres (p<0.001). At centre 1, sensitivity was 48.6% (95% CI 31.9% to 65.6%) using the stringent and 89.2% (95% CI 74.6% to 97.0%) using the broad definition. At centre 2, sensitivity was 36.0% (95% CI 22.9% to 50.8%) and 50.0% (95% CI 35.5% to 64.5%), respectively. Combined sensitivity for perforation was 37.5% (95% CI 8.5% to 75.5%) using the stringent and 62.5% (95% CI 24.5% to 91.5%) using the broad definition. Adding procedure codes and non-emergency contacts slightly increased sensitivity but increased false positives. Conclusions: Use of claims data underestimated adverse event rates following colonoscopy. Difference in coding practice across hospitals underscores the need for standardised reporting in screening programmes. Trial registration number: NCT01538550 .

Zusammenfassung: Hintergrund: Trotz fallender Inzidenz und Mortalität ist Darmkrebs (kolorektales Karzinom) in Deutschland immer noch die zweithäufigste Krebserkrankung bei Frauen (nach Brustkrebs) und die dritthäufigste bei Männern (nach Prostata- und Lungenkrebs). Darmkrebs eignet sich gut für Vorsorge oder Früherkennung mittels Screening. Die zwei vornehmlich empfohlenen Tests sind die Koloskopie und der fäkale immunchemische Test (FIT; Stuhltest auf okkultes Blut). Ziel der Arbeit (Fragestellung): Der vorliegende Beitrag erklärt wichtige konzeptuelle und praktische Unterschiede der angebotenen Screeningtests in Deutschland und beschreibt die neueste Evidenzlage für den Nutzen der am häufigsten angewendeten Screeningmethoden. Ziel des Beitrags ist es, Ärzten Entscheidungshilfen zu geben für Patienten, die sich für das Darmkrebsscreening interessieren. Material und Methoden: Gesicherte qualitativ hochwertige Evidenz aus randomisierten Studien zum Nutzen des Darmkrebsscreenings in Bezug auf Inzidenz und Mortalität des kolorektalen Karzinoms. Ergebnisse: Das Lebenszeitrisiko in Deutschland, an Darmkrebs zu erkranken, beträgt derzeit 5 % bei Frauen und 6,5 % bei Männern. Laut einer großen randomisierten Studie reduziert eine Vorsorgekoloskopie das Risiko von Darmkrebs über 10 Jahre von 1,2 % auf ungefähr 0,8–0,9 %. Neue Evidenz einer großen spanischen randomisierten Studie zeigt, dass der Nutzen eines FIT-Screenings jedes zweite Jahr als gleichwertig zur einer Koloskopie über 10 Jahre einzuordnen ist. Das Risiko einer Perforation während einer Koloskopie liegt bei ungefähr 0,01 %, und das Risiko einer Blutung bei 0,1 %. Schlussfolgerung: Bei der ärztlichen Patientenaufklärung zum Screening wird empfohlen, die oben genannten Zahlen für Nutzen und Risiko heranzuziehen und zu erklären.

Fecal microbiota transplantation (FMT) is recommended for recurrent Clostridioides difficile infection (CDI), but its role in primary CDI is unclear. To investigate the efficacy and safety of FMT in primary CDI. Randomized, open-label, noninferiority, multicenter trial. (ClinicalTrials.gov: NCT03796650). Hospitals and primary care facilities in Norway. Adults with CDI (C difficile toxin in stool and ≥3 loose stools daily) and no previous CDI within 365 days before enrollment. FMT without antibiotic pretreatment versus oral vancomycin, 125 mg 4 times daily for 10 days. The primary end point was clinical cure (firm stools or P for noninferiority < 0.001, rejecting the hypothesis that response to FMT is 25 percentage points lower than response to vancomycin). Eleven patients in the FMT group and 4 in the vancomycin group had additional C difficile treatment. Clinical cure at day 14 and no recurrence with or without additional treatment was observed in 40 of 51 patients (78.4%) with FMT and 30 of 49 (61.2%) with vancomycin (difference, 17.2 percentage points [95.2% CI, -0.7 to 35.1 percentage points]). No significant differences in adverse events were observed between groups. Open-label design and reliance on clinical end points. FMT may be considered as first-line therapy in primary CDI. South-East Norway Health Trust.

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Commercial, regulatory-approved computer-aided detection (CADe) tools are widely used in colonoscopy; however, open-source multimodal large language models may present a promising alternative. This study compared the polyp detection performance of two such models—GPT-4o and Gemini 1.5 Pro—with ENDO-AID CADe, a commercial artificial intelligence (AI) system, using colonoscopy videos. Per-lesion sensitivities were 75% for GPT-4o, 50% for Gemini and 87% for ENDO-AID. While the large language models were less effective at detecting polyps ≤5 mm, they performed comparably for larger lesions, suggesting their potential as alternative AI tools in endoscopic practice.