Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases

Обзор

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.

Подробное описание

As the sensitivity of CC and CCE is constantly increasing and progressively smaller-size pathologies are detected, the association between detected lesions and patients short- and long-term outcomes is becoming more uncertain. In some cases, such as with the resection of diminutive polyps, the number needed to treat to save one person (approx. 8.000) is very close to the number needed to cause one procedure-related death (10.000). Therefore, there is an increasing need to filter CC candidates and define a realistic threshold for treating or ignoring lesions.

The DanCap study fulfils this need by introducing a renewed approach to the diagnostic pathways using CCE. This approach offers out-of-hospital, accurate bowel diagnostics that allow for the decongestion of endoscopic services, as seen in the UK. It has an upscaling potential for national and international redesign of bowel diagnostics. Several clinical trials have demonstrated the strengths and weaknesses of CCE as compared to CC. The Scottish and English Services have shown the feasibility of routine use of CCE and the CCE-based services confirmed already known data with real-world equivalents regarding CCE's safety and high diagnostic quality. However, there are remaining concerns, primarily due to the high (45-60%) re-investigation rate, which makes the patient experience and cost-efficiency of CCE-based services inferior to that of the conventional CC counterpart. Based on these recent findings, setting up a routine diagnostic pathway for further evaluation of CCE in the clinical routine of patients with a low frequency of positive findings, including cost-efficiency assessment, is highly relevant. Here, introducing methods to predict a patient's findings may be extra relevant in the future. Currently, studies suggest that the use of faecal haemoglobin concentration or the microbiome composition may be useful biomarkers for colorectal cancer or precursor lesions. The predictive potential of these biomarkers in a diagnostic pathway has yet to be sufficiently tested, and more evidence is needed before clinical application is possible.

Our study aims to investigate the DanCap pathway as a viable solution for CCE-based diagnostics in symptomatic patients, considered to have a high need for endoscopic evaluation due to the symptoms compatible with neoplastic disease, as referred from general practice (GP). This approach is expected to be cost-effective and maintain high clinical quality while relieving the burden on endoscopy wards in a Danish setting.

The study will provide data for pathway cost analysis of the CCE-based pathway compared to the traditional colonoscopy pathway based on a realistic medicine outcomes assessment.

The secondary aims are to:

1. Compare the polyp detection rate (PDR) and CRC detection rates in both groups 2. Investigate the role of FIT-testing and microbiome analyses in CCE-based diagnostics for predictive purposes

Вмешательства

• Диагностический тест CCE arm
  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
• Диагностический тест CC arm
  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.

Первичные конечные точки

• Cost consequence analysis [Срок оценки: 1 year]

Вторичные конечные точки (4)

• Reinvestigation rate of CCE [Срок оценки: 1 year]
• Comparative analysis of detection rates for CCE and CC [Срок оценки: 1 year]
• Predictive value of FIT [Срок оценки: 1 year]
• Gut microbiome [Срок оценки: 1 year]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Дания · 1 центр

• Odense University Hospital — Odense C

Публикации

• 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
• 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
• 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 PMID 36214590
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06475560 · 322-2023-AK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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