To compare adenoma detection rates of colonoscopy with and without a CADe system during surveillance colonoscopy of patients with Lynch syndrome.
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adenoma detection rate of colonoscopy with CADe system versus colonoscopy
without CADe system
Secondary outcome
- The difference in polyp detection rate between colonoscopy with and without
CADe system
- The difference in mean number of polyps between colonoscopy with and without
CADe system
- The difference in mean number of adenomas between colonoscopy with and
without CADe system
- The difference in mean number of serrated polyps between colonoscopy with and
without CADe system
- The difference in proximal serrated polyp detection rate between colonoscopy
with and without CADe system
- The difference in mean number of proximal serrated polyps between colonoscopy
with and without CADe system
- The mean duration of both endoscopic procedures with and without CADe system:
time for inspection and time for performing endoscopic resection
- False positive detections of the CADe system: a flashing alert (whereby a
detection box, circle and/or sound signal appears then disappears) and
consistent false detection (whereby the CADe system consistently identifies a
non-polyp structure as a polyp but the endoscopist disagrees at close
observation)
Background summary
Colonoscopy with computer-aided detection (CADe) has been shown to improve
detection of colon polyps and adenomas in the average-risk population during
randomized trials. Patients with Lynch syndrome have accelerated carcinogenesis
and even the smallest polyps have malignant potential. In addition, polyps in
patients with Lynch syndrome are more often non-polypoid and proximally
located, and therefore more difficult to recognize. Increasing polyp and
adenoma detection rates with CADe systems is therefore of importance. Recently
Fujifilm has developed a new technology known as *CAD EYE* to support colonic
polyp detection and characterization during colonoscopy, utilizing Fujifilm's
medical AI technology named REiLI (CADE-EYE, Fujifilm, Japan). Recently, in an
image-based study setting, this CAD EYE detection system showed a sensitivity,
specificity and accuracy of 92.9%, 90.6% and 91.7%, respectively [24]. To this
date, no study has assessed this CAD EYE Detection technique in a comparable
fashion for adenoma detection in patients with Lynch syndrome or regular
surveillance patients.
Study objective
To compare adenoma detection rates of colonoscopy with and without a CADe
system during surveillance colonoscopy of patients with Lynch syndrome.
Study design
International, multicenter, parallel, randomized controlled trial
Intervention
HD-WL endoscopy with computer aided detection system
Study burden and risks
Each colonoscopy is associated with a small, but not negligible risk of
bleeding (~1%) or perforation (~0.1%). The use of the CADe does not increase
the risk of endoscopy.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes
(MLH1, MSH2, MSH6) or deletions in the 3* region of the EpCAM gene
- Age >18 years
- Surveillance colonoscopy for Lynch syndrome.
Exclusion criteria
- Recent surveillance colonoscopy within 1 year from current exam (e.g. after
piecemeal EMR) or patients referred for endoscopic evaluation of known
colorectal neoplasia.
- Colonoscopy planned for the evaluation of symptoms like rectal blood loss,
recent change in bowel habits, weight loss or anemia.
- Patients with a concurrent diagnosis of (serrated) polyposis syndrome or
inflammatory bowel disease.
- Patients who are unwilling or unable to give informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77827.018.21 |