Background: PolyDeep is a computer-aided detection and characterization system that has demonstrated a high diagnostic yield for in vitro detection of colorectal polyps. Our objective is to compare the diagnostic performance of expert endoscopists and PolyDeep for colorectal polyp detection. Methods: PolyDeep Advance 1 (NCT05514301) is an unicentric diagnostic test study with a second observer design. Endoscopists performed colonoscopy blinded to PolyDeep’s detection results. The main endpoint was the sensitivity for colorectal polyp (adenoma, serrated or hyperplastic lesion) detection. The secondary endpoints were the diagnostic performance for diminutive lesions (≤5 mm), neoplasia (adenoma, serrated lesion) and adenoma detection. Results: We included 205 patients (55.1% male, 63.0 ± 6.2 years of age) referred to colonoscopy (positive faecal immunochemical occult blood test = 60.5%, surveillance colonoscopy = 39.5%). We excluded eight patients due to incomplete colonoscopy. Endoscopists detected 384 lesions, of which 39 were not detected by PolyDeep. In contrast, PolyDeep predicted 410 possible additional lesions, 26 of these predictions confirmed by endoscopists as lesions, resulting in a potential 6.8% detection increase with respect to the 384 lesions detected by the endoscopists. In total, 410 lesions were detected, 20 were not retrieved, five were colorectal adenocarcinoma, 343 were colorectal polyps (231 adenomas, 39 serrated and 73 hyperplastic polyps), 42 were normal mucosa and 289 were ≤5 mm. We did not find statistically significant differences between endoscopists and PolyDeep for colorectal polyp detection (Sensitivity = 94.2%, 91.5%, p = 0.2; Specificity = 9.5%, 14.3%, p = 0.7), diminutive lesions (Sensitivity = 92.3%, 89.5%, p = 0.4; Specificity = 9.8%, 14.6%, p = 0.7), neoplasia (Sensitivity = 95.2%, 92.9%, p = 0.3; Specificity = 9.6%, 13.9%, p = 0.4) and adenoma detection (Sensitivity = 94.4%, 92.6%, p = 0.5; Specificity = 7.2%, 11.8%, p = 0.2). Conclusions: Expert endoscopists and PolyDeep have similar diagnostic performance for colorectal polyp detection.

Background: Organised colorectal cancer (CRC) screening programmes have been widely implemented across Europe; however, robust population-level evaluations of their real-world effectiveness, particularly for programmes based exclusively on faecal immunochemical testing (FIT), remain limited. The Galician CRC screening programme was progressively implemented between 2013 and 2019. Methods: We conducted a population-based ecological time-series study using data from the Galician Tumour Registry (ICD-10 C18–C21) for 2015–2023. Age-standardised mortality (ASMR) and incidence (ASIR) rates were analysed. They were calculated using the direct standardisation method, applying age-specific rates to the 2013 European Standard Population (ESP2013). Structural changes associated with programme implementation were evaluated using interrupted time-series (ITS) models, estimating annual percent change (APC) before and after implementation and the net change in slope (ΔAPC). Absolute and relative changes in ASMR and ASIR were calculated by comparing 2015–2017 and 2019–2023. Analyses were performed for the overall population and for individuals aged 50–69 years. Results: Between 2015 and 2023, overall CRC mortality declined significantly (APC −3.00%; 95% CI −3.37 to −2.63). ITS analysis demonstrated a marked modification of mortality trajectories following programme implementation. Mortality shifted from an increasing pre-implementation slope (APC +13.70%; 95% CI 10.12, 17.39) to a significant annual decline post-implementation (APC −3.62%; 95% CI −4.47, −2.76), yielding a ΔAPC of −17.32. In individuals aged 50–69 years, the structural change was more pronounced (ΔAPC −19.88), with post-implementation mortality decreasing by −8.08% annually (95% CI −10.43, −5.66). Incidence showed a comparable structural modification. Overall APC changed from +15.26% (95% CI 5.48, 25.95) before implementation to −2.48% (95% CI −5.29, 0.41) afterwards (ΔAPC −17.74). In the screening-eligible population, APC shifted from +21.32% (95% CI 4.60, 40.71) to −3.74% (95% CI −7.62, 0.30), corresponding to a ΔAPC of −25.06. Descriptively, ASMR declined from 41.92 to 35.91 per 100,000 (−14.33%), and ASIR from 98.37 to 85.16 per 100,000 (−13.42%) between 2015 and 2017 and between 2019 and 2023. Relative reductions were larger in individuals aged 50–69 years and were more pronounced for colon cancer than for rectal cancer. Conclusions: Implementation of an organised FIT-based screening programme was associated with a structural change in CRC mortality and incidence trends, particularly among individuals aged 50–69 years.

Colorectal cancer is the third most common cancer worldwide and presents a high mortality rate. Colonoscopy is the gold standard for screening, as it can reduce its incidence and mortality. Deep Learning techniques have become state-of-the-art in lesion detection and classification, and several Deep-Learning-based Computer-Aided Diagnosis systems are already undergoing clinical evaluation or commercialization. However, the development of reliable models requires large, high-quality datasets, which are costly and time-consuming to create. Thus, the availability of public datasets is critical for the scientific community to develop artificial intelligent models. This work aims to contribute to the available resources by presenting PIBAdb, a new multimodal public cohort of colorectal videos and images. The PIBAdb cohort contains polyp data derived from routine colonoscopies conducted between January 2018 and May 2021 at Hospital Universitario de Ourense, under the PolyDeep project. Each polyp was resected, histologically analysed, morphologically classified, and annotated by expert clinicians with bounding boxes in images and temporal segments in videos. The main characteristics of PIBAdb were compared with another 25 public datasets. The utility of PIBAdb was evaluated in polyp detection and classification scenarios using Deep Learning models. PIBAdb includes detailed clinical and histological metadata from 1176 polyps, 31,946 manually annotated polyp images, 14,124 non-polyp images, nearly 7 h of annotated video segments showing polyps, and over 4 h of annotated video segments without polyps. It comprises both the raw database and several curated image datasets, each accompanied by metadata and documentation. PIBAdb is publicly available upon request for non-profit purposes. PIBAdb is one of the largest and most complete multimodal public datasets for colorectal polyp research. It is characterized by its rich per-polyp metadata (histology and PARIS/NICE classifications), inclusion of NBI and WL images, and non-polyp images at multiple levels of cleanness. While the image datasets included are practical for developing classification or detection models, the full database enables more complex video-based research and custom dataset creation using the PIBA management tool, supported by a queryable relational database. Its availability is expected to support the development of Deep Learning models and to foster future contributions from the research community.

Background and study aims: Computer-aided detection (CADe) increases adenoma detection in colonoscopy, but its effectiveness in post-polypectomy surveillance remains uncertain. This study compared CADe-assisted versus standard high-definition colonoscopy for adenoma detection rate (ADR) during surveillance. Patients and methods: We conducted a population-based, randomized controlled trial in the Galician colorectal cancer screening program. Colonoscopy days were randomized in a 1:1 ratio to high-definition colonoscopy with or without CADe. The primary endpoint was ADR. Prespecified subgroup analyses evaluated endoscopist baseline performance (median ADR in the standard arm). Effect estimates are reported as adjusted risk ratios (aRR) and confidence interval (CI). Results: Of 5,309 randomized surveillance colonoscopies, 4,824 surveillance colonoscopies were included in the final analysis (2,469 standard; 2,355 CADe-assisted) after exclusion of incomplete examinations. ADR did not differ between groups (57.4% vs 58.8%; aRR 1.02 [95% CI 0.95–1.10]). CADe increased ADR among low-performing (ADR<54.5%) endoscopists (45.5% vs 52.1%; aRR 1.15 [95% CI 1.01–1.30]), but not among high-performing endoscopists (65.9% vs 63.5%; aRR 0.96 [95% CI 0.88–1.05]). Conclusions: In a high-performing screening program, CADe did not increase ADR in surveillance colonoscopy. Its benefit may be limited to lower-performing endoscopists.

Background/Objectives: Computer-aided detection (CADe) systems are increasingly used in endoscopy to enhance lesion recognition. PolyDeep is a CADe/x tool previously assessed in an observational study. The aim of our study is to determine if PolyDeep-assisted colonoscopy reduces the adenoma miss rate (AMR) compared with conventional colonoscopy. Methods: We carried out a multicenter randomized controlled trial with a tandem colonoscopy design in participants from a colorectal cancer screening program (positive fecal immunochemical test-FIT or surveillance). Expert endoscopists performed all colonoscopies, and patients were allocated to groups by a computer-generated sequence. The primary endpoint was AMR; secondary endpoints included polyp miss rate (PMR), serrated lesion miss rate (SLMR) and advanced polyp miss rate (APMR). Results: From May to November 2023, we recruited 260 patients and excluded 20, leaving 240 for analysis. Baseline characteristics were balanced between groups (62.1% male; mean age 62.3 ± 6.5 years; 65.8% FIT-positive; mean first withdrawal time 13:38 ± 08:07 min; mean second withdrawal time 07:50 ± 03:38 min; lesion detection rate 76.6%; mean polyps per patient 3.4 ± 3.1). We did not find statistically significant differences between PolyDeep-assisted and conventional colonoscopy groups in AMR (21.3% vs. 18.1%, p = 0.5), PMR (21.8% vs. 20.3%, p = 0.7), SLMR (23.4% vs. 25.6%, p = 0.9) or APMR (7.3% vs. 11.3%, p = 0.5). In the subgroup analysis according to indication, we did not find any statistically significant differences. Conclusions: In the context of a CRC screening program, PolyDeep-assisted colonoscopy did not reduce AMR.

Background: Organized colorectal cancer (CRC) screening programs have been widely implemented across Europe; however, robust population-level evaluations of their real-world effectiveness, particularly for programmes based exclusively on faecal immunochemical testing (FIT), remain limited. The Galician CRC screening programme was progressively implemented between 2013 and 2019. Methods: We conducted a population-based ecological time-series study using data from the Galician Tumour Registry (ICD-10 C18–C21) for 2015–2023. Age-standardized mortality (ASMR) and incidence (ASIR) rates were analyzed. Structural changes associated with program implementation were evaluated using interrupted time-series (ITS) models, estimating annual percent change (APC) before and after implementation and the net change in slope (ΔAPC). Absolute and relative changes in ASMR and ASIR were calculated by comparing 2015–2017 and 2019–2023. Analyses were performed for the overall population and for individuals aged 50–69 years. Results: Between 2015 and 2023, overall CRC mortality declined significantly (APC −3.00%; 95% CI −3.37 to −2.63). ITS analysis demonstrated a marked modification of mortality trajectories following program implementation. Mortality shifted from an increasing pre-implementation slope (APC +13.70%; 95% CI 10.12, 17.39) to a significant annual decline post-implementation (APC −3.62%; 95% CI −4.47, −2.76), yielding a ΔAPC of −17.32. In individuals aged 50–69 years, the structural change was more pronounced (ΔAPC −19.88), with post-implementation mortality decreasing by −8.08% annually (95% CI −10.43, −5.66). Incidence showed a comparable structural modification. Overall APC changed from +15.26% (95% CI 5.48, 25.95) before implementation to −2.48% (95% CI −5.29, 0.41) afterwards (ΔAPC −17.74). In the screening-eligible population, APC shifted from +21.32% (95% CI 4.60, 40.71) to −3.74% (95% CI −7.62, 0.30), corresponding to a ΔAPC of −25.06. Descriptively, ASMR declined from 41.92 to 35.91 per 100,000 (−14.33%), and ASIR from 98.37 to 85.16 per 100,000 (−13.42%) between 2015–2017 and 2019–2023. Relative reductions were larger in individuals aged 50–69 years and were more pronounced for colon cancer than for rectal cancer. Conclusions: Implementation of an organized FIT-based screening program was associated with a structural change in CRC mortality and incidence trends, particularly among individuals aged 50–69 years.