Trial reportGut2025
Choice of colon capsule or colonoscopy versus default colonoscopy in FIT positive patients in the Danish screening programme: a parallel group randomised controlled trial.
Trial report in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04049357 (Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Patient-Level Predictors of Procedural Success in Colon Capsule Endoscopy: A Systematic Review and Meta-Analysis.Journal of gastroenterology and hepatology · 2026Pooled it
- Colon Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases (DanCap): Protocol for a Cluster-Allocated Crossover Trial.Diagnostics (Basel, Switzerland) · 2026Article
- Associations between patient characteristics and completeness of colon capsule endoscopy in colorectal cancer screening participants: a cross-sectional study.BMJ open gastroenterology · 2026Article
- Expected Values of Artificial Intelligence in Colon Capsule Endoscopy: Artificial Intelligence in Capsule Endoscopy Consortium Position Statement.Endoscopy international open · 2026Article
- Re-investigation rate following colon capsule endoscopy stratified by faecal haemoglobin concentration in a screening population.Therapeutic advances in gastroenterology · 2026Article
- Reply to Lei et al. Comment on "Altobelli et al. Colon Capsule Endoscopy as a Promising Diagnostic Tool in Colorectal Cancer: A Systematic Review and Network Meta-Analysis.Diagnostics (Basel, Switzerland) · 2025Article
- Comment on Altobelli et al. Colon Capsule Endoscopy as a Promising Diagnostic Tool in Colorectal Cancer: A Systematic Review and Network Meta-Analysis.Diagnostics (Basel, Switzerland) · 2025Article
- Review
- Colon Capsule Endoscopy as a Promising Diagnostic Tool in Colorectal Cancer: A Systematic Review and Network Meta-Analysis.Diagnostics (Basel, Switzerland) · 2025Review
- Colon capsule endoscopy today: Brief overview of leading UK and Danish initiatives.Endoscopy international open · 2025Review
- Marking 25 years of capsule endoscopy: from bold innovation to enduring legacy.Therapeutic advances in gastrointestinal endoscopyArticle
- Applicability of colon capsule endoscopy in FIT-positive individuals unable or unwilling to undergo colonoscopy within a colorectal cancer screening programme: a prospective multicentre study.Therapeutic advances in gastrointestinal endoscopyArticle
- Clinical Prediction Models to Guide the Selection of Patients for Colon Capsule Endoscopy Versus Colonoscopy Following FIT-Positive Screening.Cancer control : journal of the Moffitt Cancer CenterArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundColonoscopy is among the standard tests for colorectal cancer (CRC) screening. However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available. The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting.
objectiveThe primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy.
designA randomised, intention-to-treat trial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT). The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms.
resultsA total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test. Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups. Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods. In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy. Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy. The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm.
conclusionOffering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test. Instead, it led to a very high rate of secondary colonoscopies. Therefore, CCE cannot be recommended in this setting. TRIAL REGISTRATION NUMBER: NCT04049357 (ClinicalTrials.gov).
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