Z80.0
Conditions
Interventions
Group 1: Standard high-definition white-light endoscopy (HD-WLE) in Lynch syndrome patients during colorectal cancer surveillance
Group 2: Standard high-definition white-light endoscopy (HD-WLE) and a
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General inclusion criteria: Age =18 years Written informed consent of the subject for voluntary participation in the study Subjects with the ability to follow study instructions and likely to attend and complete all required visits Indication-specific inclusion criteria: Diagnosis of Lynch-syndrome (presence of a (likely-) pathogenic germline variant in MLH1, MSH2, MSH6, PMS2; deletion in the 3` region of the EPCAM gene) Surveillance colonoscopy
Exclusion criteria
Exclusion criteria: General exclusion criteria: Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this study Patients with a physical or psychiatric condition/ a systemic disease which at the investigator’s discretion may compromise safety of the subject, may confound the trial results, may interfere with the subject’s participation in this clinical study or may prevent sufficient compliance Simultaneously participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning Exclusion criteria regarding special restrictions for females: Current pregnancy Indication specific exclusion criteria: Previous extensive colorectal surgery (proctocolectomy or colectomy with ileorectal anastomosis) Recent surveillance colonoscopy within 12 months from current examination Symptoms such as rectal bleeding, change in bowel habits, unexplained weight loss, anemia Concomitant inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the adenoma detection rate (ADR) during high-definition white-light endoscopy (HD-WLE) with versus without real-time automated detection (CAD EYE Fujifilm) | — |
Secondary
| Measure | Time frame |
|---|---|
| Total/mean number and size of detected adenomas Detection rate, mean and total number of advanced adenomas Detection rate, mean and total number of polyps Detection rate, number of adenomas in relation to morphology (ac-cording to Paris classification) Detection rate and number of colorectal carcinomas Detection rate, mean and total number of sessile serrated lesions Detection rate, total and mean number of proximal serrated polyps Detection rate, total and mean number of proximal adenomas Detection rate, total and mean number of sessile serrated lesions, ad-enomas and carcinomas in dependence to the previous colonoscopy result and interval and underlying pathogenic variant Detection rate, total and mean number of sessile serrated lesions, ad-enomas and carcinomas in dependence to previous CAD EYE experience and/or center Mean examination/procedure time with and without CAD EYE system (examination time and time of endoscopic therapy) Specificity and sensitivity of the polyp differentiation mode of the CAD EYE system Rate of false positives of the CADEYE system Occurrence of (serious) adverse events | — |
Countries
Germany, Netherlands, Spain
Contacts
Public ContactRobert Hüneburg
Universitätsklinikum Bonn
Outcome results
None listed