Colon capsule endoscopy diagnostic accuracy compared with as standard colonoscopy Digestive System
Conditions
Interventions
This study has three research workstreams (WS). In WS 1, a paired (back-to-back) study will be performed. Patients due for a colonoscopy because of suspected serious bowel disease or for routine surve
Sponsors
York Teaching Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with suspected CRC who have had a FIT within 3 months of referral, where a new IBD Colitis is suspected or patients having a 3-yearly post-polypectomy surveillance colonoscopy 2. Patients who feel they can tolerate a same-day CCE and colonoscopy investigation or would be willing to have the colonoscopy on an alternative day 3. Patients who feel able to swallow the CCE 4. Patients who are able and willing to give informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Patients < 18 years 2. Patients who are unable to safely swallow the CCE* 3. Patients who are unable to safely and fully comply with the bowel preparation* 4. Patients clinically at risk of stricturing bowel disease, such as Crohn’s disease 5. Patients who have ever received abdominal or pelvic external beam radiotherapy 6. Patients with a history of bowel obstruction 7. Patients who have had a (partial) colectomy 8. Patients who are currently pregnant or breastfeeding 9. Symptomatic patients with suspected CRC who have not had a FIT within 3 months of referral 10. Patients with a permanent pacemaker or other implanted electromedical device 11. Patients who will not be able to safely tolerate the study* 12. Patients in whom the bowel preparation for CCE will likely be inadequate? * These exclusion criteria will require some clinical judgement in line with the existing approach to CCE and colonoscopy in clinical practice. Judgement of ability to tolerate the study requires an assessment of frailty per se, rather than a specific co-morbidity. However, it is likely to include patients with conditions such as cirrhosis, diabetes, stroke, peripheral vascular, heart or renal disease or cognitive impairment. ?This exclusion criteria will also require some clinical judgement in line with the existing approach to CCE and colonoscopy in clinical practice. It will include patients with slow gastrointestinal motility, such as idiopathic slow transit constipation, those currently using opioid or tricyclic antidepressant medication, a history or prior poor bowel preparation and/or who require regular laxatives in their daily rounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per-patient detection of the combined endpoint of visible mucosal colorectal lesions (CRC, polyps and colitis) in participants who have had a complete and adequately prepared colon capsule endoscopy (CCE) and colonoscopy; the endpoint will include post-review colonoscopy when appropriate, on days 0-7 for per-patient reporting with interim analyses in months 12, 18, 24, 30 and 36, and final analysis between months 36-40 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed on days 0-7 for per-patient reporting with interim analyses in months 12, 18, 24, 30 and 36, and final analysis between months 36-40: 1. Diagnostic accuracy for specific lesion types including all polyps and by size (9mm) 2. Per-lesion matching 3. Colon capsule endoscopy (CCE) completion rates and times, bowel preparation adequacy rates, retention rates and adverse events will be recorded while for colonoscopy it will be standard performance measures and adverse events 4. CCE performance characteristics compared to colonoscopy will be assessed based on patient demographics, FIT and other disaggregated groups 5. A supplementary ‘intention to investigate’ comparative analysis of CCE versus colonoscopy Further objectives will be measured as follows: 6. Intra- and inter-reader variability assessed via the identification and impact of any variability on diagnostic accuracy of CCE. A structured proforma will be developed to address this at months 28-37 7. The development of health economic models (months 17-37) assessed by evaluating the costs and benefits of CCE in relevant patient groups will be undertaken between months 38-40: The key outputs of the symptomatic and surveillance CRC models will be: 7.1. Total incremental costs 7.2. Total incremental QALYs and life-years 7.3. Cost per colonoscopy avoided 7.4. The excess number of CRC detected 7.5. For IBD colitis a third model will be developed to capture the economic impact of using CCE within the diagnostic pathway for IBD 8. The evaluation of the patient and clinician experience of CCE will be measured using qualitative analyses to provide a thematic account, using patient and clinician experience, between months 34-39 | — |
Countries
England, United Kingdom
Contacts
Public ContactMonica Haritakis
Outcome results
None listed