The aims of this study are: 1) to evaluate the neoplasia miss-rate of AFI in patients with longstanding UC during colonoscopic surveillance; 2) to evaluate the feasibility of miniprobe-based confocal endomicroscopy in these patients; 3) to compareā¦
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of this study will be: 1) the neoplasia miss-rate of AFI
(per lesion analysis) and 2) the feasibility of confocal endomicroscopy,
expressed as diagnostic accuracy when compared to final histopathology.
Secondary outcome
Secondary outcomes: 1) the accuracy of AFI plus NBI for the endoscopic
diagnosis of lesions compared to confocal endomicroscopy, and 2) the yield for
neoplasia of real random biopsies compared to optical biopsies by confocal
endomicroscopy.
Background summary
Patients with longstanding ulcerative colitis (UC) are at increased risk of
developing colorectal cancer and therefore undergo regular colonoscopic
surveillance. Random biopsies are taken during surveillance, since neoplasia
mainly exists in flat mucosa and is grossly invisible at conventional
colonoscopy. Random biopsies increase workload and costs for both endoscopists
and pathologists. Novel endoscopic imaging techniques like high resolution
endoscopy (HRE), autofluorescence imaging (AFI), narrow band imaging (NBI) and
confocal endomicroscopy facilitate the detection of neoplasia and improve the
discrimination of neoplastic from non-neoplastic mucosa. Hence, the use of
these new techniques might eliminate the need for taking random biopsies and
might reduce false positive biopsies as well.
Study objective
The aims of this study are: 1) to evaluate the neoplasia miss-rate of AFI in
patients with longstanding UC during colonoscopic surveillance; 2) to evaluate
the feasibility of miniprobe-based confocal endomicroscopy in these patients;
3) to compare the accuracies of the combined use of AFI plus NBI with confocal
endomicroscopy for the endoscopic prediction of histopathology of detected
lesions; 4) to compare the yield of random biopsies with the yield of confocal
endomicroscopic optical biopsies.
Study design
Patients with longstanding UC will undergo colonoscopic surveillance by AFI.
All detected lesions will be inspected by NBI and confocal endomicroscopy for
prediction of histopathology. Biopsies from detected lesions will be used as
the gold standard diagnosis. After examination by AFI, random biopsies (with
HRE) will be taken according to current clinical guidelines. Before taking
these random biopsies, confocal endomicroscopy will be performed from the
corresponding sampling sites.
Study burden and risks
The endoscopic procedure is comparable to the standard procedure for regular
patient care with the exception of performing additional confocal
endomicroscopy. The use of AFI and confocal endomicroscopy do not increase the
risk of complications. The accepted risk of a diagnostic colonoscopy is minimal
(~0%).
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
disease history > 8 years; endoscopic and histopathological evidence of UC; and current inactive disease assessed by the modified Truelove and Witts severity index (of < 2)
Exclusion criteria
allergy to fluorescein; non-correctable coagulopathy; age * 18 years; and inability to give informed consent
Design
Recruitment
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 | NL19805.018.07 |