Comparing differentiation and detection of neoplasia in patients with ulcerative colitis undergoing surveillance, by ETMI and CE, in a randomised trial.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparing ETMI and CE for detection of neoplasia in patients with ulcerative
colitis
Secondary outcome
- Diagnostic accuracy of ETMI vs. CE for the differentiation of neoplastic and
non-neoplastic mucosa, using final histopathology as reference standard
diagnosis.
- Determination of endoscopic features that predict the presence of a colitis
associated dysplasia (CAD), or a sporadic dysplastic lesion (SDL).
- The yield of random biopsies, defined by the number of patients with
neoplasia detected by random biopsies only (confirmed by histopathology).
- Location of neoplasia detected during surveillance colonoscopy
- Mean duration of both endoscopic procedures, ETMI vs. CE
Background summary
Surveillance colonosocopy in patients with longstanding ulcerative colitis
leads to early detection of neoplasia in the colon.Previous research in
experienced centers has shown that two surveillance strategies are better that
conventional colonoscopy with white light. ETMI, a combination of AFI and NBI,
and chromoendoscopy (CE). When neoplasia are detected it remains uncertain
whether these are colitis associated or just sporadic, as could happen in every
other person.
We expect that both strategies are equally efficient. However, CE is
labor-intensive and cost-inefficient, because of the use of Methylene Blue,
while ETMI appears to be more time and cost efficient. This research proposal
will be the first study that compares ETMI and CE for detection and
differentiation of early neoplasia in patients with ulcerative colitis.
Study objective
Comparing differentiation and detection of neoplasia in patients with
ulcerative colitis undergoing surveillance, by ETMI and CE, in a randomised
trial.
Study design
Randomised contrelled trial: subsequently patients with longstanding ulcerative
colitus will be randomised to undergo or ETMI or CE as surveillance colonoscopy.
(1) ETMI: AFI will be used for the detection of neoplastic lesions and AFI and
NBI for differentiation of neoplastic and non-neoplastic lesions
(2) CE: CE will be used for both detection as well as differention of the
detected lesions.
During colonoscopy targeted biopsies will be taken as well as 4x2 'random'
biopsies
Study burden and risks
The endoscopic procedure in this study is comparable with the standard
procedure. Besides, the colonoscopy could take a bit longer, with a maximum of
15 minutes, does not bring any extent of burden or risks related to the
procedure.The risk on complications in diagnostic colonoscopy is very low (<1%,
bleeding/perforation)
Meibergdreef 9
Amsterdam 1100 AZ
NL
Meibergdreef 9
Amsterdam 1100 AZ
NL
Listed location countries
Age
Inclusion criteria
Assymptomatic patients with ulcerative colitis
Exclusion criteria
- Change in bowel habits in the preceding two months (under maintenance therapy).
- Personal history of (partial) colectomy
- Proven genetic predisposition for colorectal cancer
- Currently known colonic neoplasia
- Non-correctable coagulopathy that precludes taking biopsies
- At introduction active inflammation visible
- Poor bowel preparation
- No 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 | NL42930.018.12 |