1) to compare NBI and standard White Light Endoscopy (WLE) for the detection of neoplasia during colonoscopic surveillance of patients with longstanding UC2) To determine the accuracy of Kudo*s classification in distinguishing neoplastic from non…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sensitivity of NBI will be compared to WLE in terms of the number of
patients with detected neoplasia.
Secondary outcome
- In addition, the number of detected neoplastic lesions will be compared
between both techniques.
- Moreover, Kudo*s classification, mucosal morphology and vascular patterns
(imaged by NBI) will be evaluated for their ability to distinguish neoplastic
and non neoplastic lesions.
Background summary
Patients with longstanding ulcerative colitis (UC) are at increased risk of
developing colorectal cancer. To reduce this risk, colonoscopic surveillance is
currently recommended in order to detect dysplasia and cancers at an early
stage. During surveillance colonoscopy random biopsies should be taken, since
neoplastic tissue exists mainly in flat mucosa and is grossly invisible at
conventional colonoscopy. Despite this laborious protocol the accuracy of this
method is low. The use of dye spraying (chromoendoscopy) has proven to be more
accurate for the detection of neoplasia but is labour-intensive and operator
dependent. Narrow Band Imaging (NBI) is a novel endoscopic imaging technique
with a similar effect as chromoendoscopy but without the use of dyes. This
technique may improve the detection and specification of lesions found during
colonoscopy.
Study objective
1) to compare NBI and standard White Light Endoscopy (WLE) for the detection of
neoplasia during colonoscopic surveillance of patients with longstanding UC
2) To determine the accuracy of Kudo*s classification in distinguishing
neoplastic from non neoplastic lesions using NBI
3) to characterize the mucosal morphology and vascular pattern of neoplastic
and non neoplastic mucosa making use of NBI.
Study design
Patients with longstanding UC will undergo colonoscopic surveillance by both
WLE and NBI with a time interval of at least 4 weeks between the procedures.
Randomization determines the order of the two techniques. During both
procedures targeted biopsies will be taken from suspicious lesions. Only during
the second procedure additional random biopsies will be taken according to
current clinical guidelines. All detected lesions will be inspected and imaged
with NBI and the mucosal morphology and vascular pattern will be classified.
The histopathological outcome of the biopsies will be used as the gold standard
for diagnosis.
Study burden and risks
The endoscopic procedures are comparable to the standard procedure for regular
patient care with the exception of performing the endoscopy twice. The use of
NBI does not increase the risk of complications. The accepted risk of a
diagnostic colonoscopy is minimal (<0.2%).
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
objective diagnosis (endoscopically and histologically proven) of ulcerative colitis
extensive colitis (defined as inflammation proximal to the splenic flexure)
disease history longer than 8 years
inactive disease
Exclusion criteria
non correctable coagulopathy
age younger than 18 years
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 | NL15028.018.06 |