The aims of the study are: 1) to characterize the mucosal morphology and vascular pattern of neoplastic and non neoplastic mucosa by NBI and standard White Light Endoscopy (WLE) in the upper gastrointestinal tract; 2) to compare the accuracy of NBIā¦
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The morphology and vascular pattern of duodenal adenomas will be
characterized by NBI and WLE and related to histopathology.
2. Making use of this characterization NBI will be compared to WLE for accuracy
in predicting high grade neoplasia and villous architecture.
Secondary outcome
Staging duodenal adenomatosis according to Spigelman's classification will be
compared between NBI and WLE.
Background summary
Familial adenomatous polyposis (FAP) is an inherited autosomal dominant
condition, in which multiple gastrointestinal adenomas are found. Aside from
colonic polyps, duodenal adenomas have a reported prevalence of nearly 100%.
Since these adenomas have a malignant potential, duodenal surveillance
endoscopies are recommended to overcome the occurrence of duodenal cancer.
Until now, no accurate method has been identified for the detection of patients
at high risk for the development of duodenal cancer. We evaluate the use of
Narrow Band Imaging (NBI) as a novel endoscopic imaging technique to define
groups at high risk for cancer development.
Study objective
The aims of the study are: 1) to characterize the mucosal morphology and
vascular pattern of neoplastic and non neoplastic mucosa by NBI and standard
White Light Endoscopy (WLE) in the upper gastrointestinal tract; 2) to compare
the accuracy of NBI and WLE for the identification of high grade neoplastic and
villous duodenal adenomas; 3) to compare NBI and WLE in staging duodenal
adenomatosis according to Spigelman's classification.
Study design
Patients with FAP will undergo an upper endoscopy with WLE, followed by a
second inspection with NBI. The stomach will be investigated for fundic gland
polyposis and suspicious polyps. In the duodenum the number and size of
detected polyps will be noted. Suspicion of duodenal adenomas is based on size
> 10 mm, central depression, irregular surface or irregular vascular pattern.
Overview and focused WLE and NBI images of all suspicious adenomas and 2
control areas are taken before sampling. Histopathology will be linked to
corresponding images. All images are reviewed according to a systematic image
evaluation process, consisting of an unblinded assessment of an exploratory set
of images and a blinded evaluation of a learning set and validation set.
Histopathological outcome will be used as gold standard for diagnosis.
Study burden and risks
In comparison to the procedure for regular patient care, the endoscopy time for
study patients takes about 5 minutes longer. Secondly, additional biopsies are
taken in study patients, although sampling by a biopsy forceps has no risk for
perforation.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
APC gene mutation on genetic testing or >100 adenomas during colonoscopy
Exclusion criteria
1) non-correctable coagulopathy
2) age * 18 years
3) 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 | NL16594.018.07 |