Clinical trial · Interventional
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed. One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\<25%-30%) is desirable for patient preference and the economy. Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC arm | Diagnostic Test | — | UNRESOLVED |
| CCE arm | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CCE arm
- description
- Symptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE.
- interventionNames
- Diagnostic Test: CCE arm
- type
- PLACEBO_COMPARATOR
- label
- CC arm
- description
- Symptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Older than 18 years * Symptomatic patient referred for colonoscopy assessment * Able to provide oral and written informed consent Exclusion criteria 1. Require hospital admission for inpatient colonoscopy 2. Previous OC with poor bowel preparation within the last 5 years 3. Patient is unable to provide oral and written informed consent 4. History of stenosis of the digestive tract 5. Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma\* 6. Patient has a pacemaker/defibrillator 7. Patient is pregnant or breastfeeding 8. Known allergies to the bowel preparation regimen 9. Have severe kidney disease 10. Known chronic constipation 11. Imaging examination suggestive for a colorectal tumour 12. Anamnestic suspicion of microscopic colitis, where biopsy is needed \*including Whipple
References
Publications (8)
- BACKGROUNDMollers T, Schwab M, Gildein L, Hoffmeister M, Albert J, Brenner H, Jager S. Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. Endosc Int Open. 2021 Apr;9(4):E562-E571. doi: 10.1055/a-1353-4849. Epub 2021 Apr 12. PMID 33860073
- BACKGROUNDDeane C, Walker C, Ryan B, O'Connor A, O'Donnell S, Breslin N, McNamara D. High diagnostic yield despite a lower completion rates for inpatient versus outpatient colon and pan-intestinal capsule endoscopy: a nested case-control study. BMC Gastroenterol. 2023 Mar 9;23(1):61. doi: 10.1186/s12876-022-02561-x. PMID 36894909
- BACKGROUNDBretthauer M, Loberg M, Wieszczy P, Kalager M, Emilsson L, Garborg K, Rupinski M, Dekker E, Spaander M, Bugajski M, Holme O, Zauber AG, Pilonis ND, Mroz A, Kuipers EJ, Shi J, Hernan MA, Adami HO, Regula J, Hoff G, Kaminski MF; NordICC Study Group. Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death. N Engl J Med. 2022 Oct 27;387(17):1547-1556. doi: 10.1056/NEJMoa2208375. Epub 2022 Oct 9. PMID 36214590
- BACKGROUNDHuffstetler AN, Fraiman J, Brownlee S, Stoto MA, Lin KW. An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review. J Am Board Fam Med. 2023 May 8;36(3):493-500. doi: 10.3122/jabfm.2022.220320R2. Epub 2023 May 11. PMID 37169588
- BACKGROUNDMacLeod C, Hudson J, Brogan M, Cotton S, Treweek S, MacLennan G, Watson AJM. ScotCap - A large observational cohort study. Colorectal Dis. 2022 Apr;24(4):411-421. doi: 10.1111/codi.16029. Epub 2022 Jan 3. PMID 34935278
- BACKGROUNDJalayeri Nia G, Arasaradnam RP, Koulaouzidis A. Clinical utility of colon capsule endoscopy: a moving target? Ther Adv Gastroenterol. 2023 Oct 9;16:17562848231195680. doi: 10.1177/17562848231195680. eCollection 2023. PMID 37822570
- Deding U, Cortegoso Valdivia P, Koulaouzidis A, Baatrup G, Toth E, Spada C, Fernandez-Urien I, Pennazio M, Bjorsum-Meyer T. Patient-Reported Outcomes and Preferences for Colon Capsule Endoscopy and Colonoscopy: A Systematic Review with Meta-Analysis. Diagnostics (Basel). 2021 Sep 20;11(9):1730. doi: 10.3390/diagnostics11091730.