The aim of this randomized controlled multi-center study is to establish whether ETMI improves the detection early colorectal neoplasia compared to standard video endoscopy in a non-expert setting and is effective in differentiating neoplastic from…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Number of patients with adenomatous polyps/neoplasia detected with
Endoscopic Tri-Modality Imaging (ETMI) or Standaard Video Endoscopy (SVE).
2) Number of adenomatous polyps/neoplastic lesions detected with ETMI and SVE
Secondary outcome
1) Number of early neoplastic lesions detected with Auto Fluorescence Imaging
(AFI) only.
2) Reduction of false positives findings after detailed NBI evaluation
(differentiating between hyperplastic and adenomatous polyps).
3) Patients* health condition.
Background summary
Colorectal carcinoma is one of the commonest cancers in the Netherlands. Its
precursor, the adenoma, can be detected and removed during colonoscopy and the
patient is cured by complete resection of such lesions. However, it is
estimated that 15-27% of small adenomas may be missed during routine
colonoscopy. Furthermore, during colonoscopy there is a need for immediate
differentiation between neoplastic and nonneoplastic lesions, since neoplastic
lesions should be removed during the same session and other lesions may be left
in situ. Recently a new endoscopic technique, autofluorescence imaging (AFI),
is developed which may improve the detection of early dysplastic lesions.
Narrow band imaging (NBI) is another novel endoscopic imaging technique that
might be useful in analysing the pit-patterns of the normal and dysplastic
mucosa. Endoscopic Trimodality Imaging incorporates these techniques (AFI, NBI)
and may improve the detection and differentiation of early neoplastic lesions.
Study objective
The aim of this randomized controlled multi-center study is to establish
whether ETMI improves the detection early colorectal neoplasia compared to
standard video endoscopy in a non-expert setting and is effective in
differentiating neoplastic from non-neoplastic lesions.
Study design
It is a randomized controlled multi-center study, at six hospitals in the
Netherlands.
Patients who are coming for surveillance will be undergo either Endoscopic
Tri-Modality Imaging (ETMI) or standard endoscopy for the detection of
gastrointestinal neoplasie.
Patients undergoing colonoscopy because of a history of adenomatous polyps, a
history of adenocarcinoma of the colon for which partial colectomy was
performed, hereditary non-polyposis colorectal cancer or a family history of
colorectal cancer at the six participating non-university hospitals will be
randomized to undergo either ETMI or standard endoscopy for the endoscopic
detection of gastrointestinal neoplasia.
The calculated sample size is 234 patients (117 per group).
Study burden and risks
Increasing the procedural time does not increase the risk of complications. The
risk of a diagnostic colonoscopy is minimal (< 1*).
Meibergdreef 9
1105 AZ
Nederland
Meibergdreef 9
1105 AZ
Nederland
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Written informed consent
- History of adenomatous polyps
- History of adenocarcinoma of the colon for which a partial colectomy was performed.
- Hereditary non-polyposis colorectal cancer
- A family history of colorectal cancer according to the revised Bethesda criteria
Exclusion criteria
- Poor bowel preparation
- familial adenomatous polyposis
- history of inflammatory bowel disease
- presence of conditions precluding histological sampling of the colon
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 | NL15099.018.06 |