The aim of this pilot study is to interrogate the feasibility of the workflow, using this image-based CAD system real-time in the endoscopy suite.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) To evaluate feasibility of the workflow of using a real-time, image-based
CAD system in the endoscopy suite.
2) To assess the preliminary diagnostic accuracy of the CAD system for
real-time detection of Barrett neoplasia.
Secondary outcome
n.a.
Background summary
Barrett*s Esophagus (BE) is a known precursor for esophageal adenocarcinoma
(EAC). BE patients undergo regular endoscopic surveillance by general
endoscopists to detect EAC at an early stage. However, endoscopic detection of
early neoplasia is difficult and early lesions are therefore often missed.
Primarily, this is due to its subtle appearance.
The ability of modern-day computers to automatically recognize informative
patterns in data sets can potentially improve endoscopic detection of early
neoplastic BE. Recently, a CAD system has been developed by the consortium that
can automatically detect and localize early neoplastic Barrett lesions on
endoscopic WLE images with high accuracy.
Study objective
The aim of this pilot study is to interrogate the feasibility of the workflow,
using this image-based CAD system real-time in the endoscopy suite.
Study design
Multicenter pilot study in which the feasibility of usage of a computer aided
detection system will be evaluated.
Study burden and risks
The endoscopic procedure will be performed according to standard practice. For
this study, only the use of the computer aided detection system is additional.
This is safe and poses no extra risks for patients.
The computer aided detection system will work separately and independantly from
the standard endoscopic equipment, since it only outputs the video signal to an
external system on a stand-alone computer with its own monitor. On this
monitor, any visual abnormalities will be displayed, that the endoscopist can
then interrogate using the standard endoscopic equipment.
Therefore there is no in-vivo use of a medical device and there are nor
additional risks for the patient.
The computer aided detection system will never make a clinical decision: The
endoscopist will always decide whether to act or not. The endoscopic procedure
will take 5-10 minutes longer, due to the collection of additional imagery.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Minimum age 18 years;
- Patients with NDBE referred for endoscopic surveillance, or patients referred
for endoscopic work-up of HGD or EAC likely to require endoscopic resection
(EMR or ESD);
- Signed informed consent.
Exclusion criteria
- Prior history of surgical or endoscopic treatment for oesophageal neoplasia;
- Presence of erosive esophagitis (Los Angeles classification *A);
- Inability to undergo EMR/ESD and/or obtain biopsies (e.g. due to
anticoagulation, coagulation disorders, varices).
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 | NL68425.018.18 |