The aims of this study are to assess the additional value of NBI in comparison to white-light endoscopy (WLE) for the detection and classification of HPs, SAs, MPs and adenomas in patients with HPS.
ID
Source
Brief title
Condition
- Gastrointestinal tract disorders congenital
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sensitivity of WLE will be compared to that of NBI for the detection of
polyps and cancer in the colon. The sensitivity of each technique will be
calculated as the number of lesions detected during the first inspection,
divided by the total number of lesions detected by both inspections.
Furthermore, the surface pit pattern of the detected lesions on NBI will be
used to obtain the overall accuracy (representing sensitivity and specificity)
of this technique, by using the histological diagnosis as the gold standard
diagnosis.
Secondary outcome
Moreover, the prevalence and distribution of HPs, SAs, MPs and adenomas in this
patient population will be described.
Background summary
Hyperplastic polyposis syndrome (HPS) is a condition in which multiple
hyperplastic polyps (HPs) are spread throughout the colon. Patients with HPS
are at increased risk of developing colorectal cancer (CRC) through a suggested
HP-serrated adenoma (SA)-CRC pathway. While complete clearing of all polyps can
sometimes prove difficult when multiple lesions exist, regular removal of at
least all lesions with a possible risk, e.g. high-risk SAs, MPs and adenomas
might adequately prevent the development of CRC. In this respect, endoscopic
detection and differentiation of these polyps as well as adenomas is an
important undertaking. However, the distinctive endoscopic appearance of SAs
has never been described. Novel endoscopic techniques, like narrow-band imaging
(NBI) may improve the endoscopic detection and differentiation of polyps in
HPS.
Study objective
The aims of this study are to assess the additional value of NBI in comparison
to white-light endoscopy (WLE) for the detection and classification of HPs,
SAs, MPs and adenomas in patients with HPS.
Study design
Patients with HPS will be evaluated by colonoscopy using a prototype endoscopic
imaging system which integrates WLE and NBI in one unit (Spectrum system,
Olympus, Tokyo, Japan). All segments of the colon will be inspected twice,
using both WLE and the NBI-mode in a randomized order. During the withdrawal
phase, any lesion found will be classified according to macroscopic appearance.
Size and localization will be recorded. Still images using white light and NBI
will be taken and the lesion will be removed. In addition, the pit-pattern
according to Kudo [4] will be scored using NBI. During the second withdrawal,
after reintroduction to the beginning of the segment, these steps will be
repeated using the other modality. The histopathological outcome of the
biopsies will be used as the gold standard diagnosis.
Study burden and risks
The endoscopic procedure in this study is comparable to the standard procedure
for regular patient care except that each segment of the colon will be
inspected twice, which may lead to increasing the procedural time with about 15
minutes. Increasing the procedural time does not increase the risk of
complications. The risk of a diagnostic colonoscopy is minimal (< 1*).
meibergdreef 9
1105 AZ, Amsterdam
Nederland
meibergdreef 9
1105 AZ, Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
All patients presenting, or under surveillance at the Endoscopy Department of the AMC with:
1) *10 HPs found at colonoscopy, or
2) *5 HPs proximal to the sigmoid colon, or
3) Any number of HPs occurring proximal to sigmoid colon in an individual who has a first-degree relative with HPS
Exclusion criteria
1) history of inflammatory bowel disease, 2) severe coagulopathy, 3) age less than 18 years and 4) insufficient bowel preparation (<90% of colonic mucosa visible).
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 | NL19031.018.07 |