Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

NCT06475560 | Recruiting DMC

• 1 other identifier: 322-2023-AK
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer

Keywords

colorectal cancer; capsule endoscopy; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Cost consequence analysis

  The cost-consequence analysis will draw on data from a variety of sources, including the National Technology Council and their cost outline, administrative data from the Department of Surgery, daily observations by the research team, timeline inputs from the clinical software 'Bookplan', patient and societal resource use from questionnaires, and other relevant information extracted from patients' electronic health records. The average cost per patient for each study arm will be estimated by integrating cost data from The Treatment Council and Department of Surgery with recorded resource use, into a consolidated estimate.

  1 year

Secondary Outcomes (4)

• Reinvestigation rate of CCE

  1 year

• Comparative analysis of detection rates for CCE and CC

  1 year

• Predictive value of FIT

  1 year

• Gut microbiome

  1 year

Study Arms (2)

CCE arm

ACTIVE COMPARATOR

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.

Diagnostic Test: CCE arm

CC arm

PLACEBO COMPARATOR

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.

Diagnostic Test: CC arm

Interventions

CC arm DIAGNOSTIC_TEST

Patients will start bowel cleansing according to the instructions. They will bring their completed questionnaire and the signed consent form to the scheduled colonoscopy. They will continue to follow the routine clinical setup for outpatient colonoscopy and will only receive, by digital post, after 2 weeks from the procedure, an extra second questionnaire.

CC arm

CCE arm DIAGNOSTIC_TEST

Twice a week, patients will attend the in-hospital clinic in groups of four persons. They will bring their completed FIT sample, questionnaire, and the signed consent form. A project nurse will administer the capsules in the morning, and the patients can leave after. When the capsule investigation is completed, patients must return their belt and receiver to the Department of Surgery, OUH. After a few days, the patient will receive an electronic letter with the results and information regarding upcoming steps. Those with positive findings or an incomplete investigation will be given a new appointment according to the current clinical routine. A second questionnaire will be sent to the patient 2 weeks after the completed procedure.

CCE arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Symptomatic patient referred for colonoscopy assessment
• Able to provide oral and written informed consent

You may not qualify if:

• Require hospital admission for inpatient colonoscopy
• Previous OC with poor bowel preparation within the last 5 years
• Patient is unable to provide oral and written informed consent
• History of stenosis of the digestive tract
• Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma\*
• Patient has a pacemaker/defibrillator
• Patient is pregnant or breastfeeding
• Known allergies to the bowel preparation regimen
• Have severe kidney disease
• Known chronic constipation
• Imaging examination suggestive for a colorectal tumour
• Anamnestic suspicion of microscopic colitis, where biopsy is needed \*including Whipple

Sponsors & Collaborators

• Odense University Hospital: lead
• Region Syddanmark: collaborator

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

RECRUITING

Related Publications (7)

• Mollers 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 BACKGROUND

• Deane 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 BACKGROUND

• Bretthauer 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 BACKGROUND

• Huffstetler 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 BACKGROUND

• MacLeod 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 BACKGROUND

• Jalayeri 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 BACKGROUND

• 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.

  PMID: 34574071 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Anastasios Koulaouzidis, Professor

  OUH og Svendborg Sygehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasios Koulaouzidis, Professor

CONTACT

23 41 49 95; Anastasios.Koulaouzidis@rsyd.dk

Alexandra D Agache, Postdoc

CONTACT

20 35 57 17; Alexandra.Agache@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-armed prospective clustered case-crossover randomized controlled trial

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)