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A Randomized Study Comparing Endoscopic Video-Autofluorescence Imaging Followed by Narrow Band Imaging With Standard Videoendoscopy for the Detection of High Risk Lesions of Stomach


Phase 3
50 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

A Randomized Study Comparing Endoscopic Video-Autofluorescence Imaging Followed by Narrow Band Imaging With Standard Videoendoscopy for the Detection of High Risk Lesions of Stomach


Gastric cancer remains one of the leading causes of cancer deaths worldwide. Early detection
and diagnosis of gastric cancer improves the outcomes of treatment. However, most of gastric
cancers detected in Singapore are late and advanced in stages.

Videoendoscopy is the standard tool for examination of gastrointestinal tract. Despite the
improvement of technology, early gastric cancers can be easily missed by routine
examination, because there are few morphological changes. Therefore, a functional imaging
modality, that can distinguish abnormal lesion from surrounding normal mucosa may complement
the current videoendoscopy.

Autofluorescence Imaging (AFI) based on the presence of natural tissue fluorescence on the
gastrointestinal tract. When the mucosa was exposed by an excitation light, certain
endogenous molecules (fluorophores) will emit fluorescence light of longer wavelength. The
fluorescent light can be detected and spectrally analyzed. By computation of the difference
in the reflecting images, the system can specify lesions, including malignancies from the
adjacent mucosa, and can reveal early cancers that are not detectable by standard endoscopy.

Narrow band imaging (NBI) is another novel optical imaging technique based on high
resolution imaging, which aims at enhancing the fine structure of the mucosa. In NBI, the
band widths of the red, blue, green components of the excitation light are narrowed to
certain wavelength ranges, which allow better contrast of the superficial mucosa and the
vascular structure. NBI has a maximum zoom capacity of 115 times. Abnormal lesions are
detected by the presence of abnormal mucosal and vascular patterns.

Recent studies suggested that these AFI and NBI systems can be complementary to each other.
The resolution of AFI is low but it can be used as a 'red flag' technique to screen any
suspicious lesions from the normal mucosa. On the other hand, NBI produces high resolution
images which allows detailed examination and subsequent target biopsy of the suspicious
lesions based on AFI. Preliminary reports from Japan and the Netherlands suggested this
combined imaging method improves the detection of early esophageal and gastric cancers.
Recently, a new endoscopy system has been developed that incorporates standard
videoendoscopy system with both AFI and NBI modes. By pressing a switch, the endoscopy
system can switch from normal white light to either a narrow band light or autofluorescence
mode. This novel system reduces the convenience and discomfort for the patients to avoid
repeated intubation. The purpose of this study is to prospectively evaluate this combined
imaging modality for detection of high risk gastric lesions and early cancers by comparing
it with standard videoendoscopy in a randomized fashion.


Inclusion Criteria:



1. Age >=50

2. Ethnic Chinese

3. Presenting symptom - dyspepsia

Exclusion Criteria:

1. Patients who are unable to give an informed consent.

2. Patients with previous surgery of the stomach.

3. Patients presented with active gastrointestinal bleeding.

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Prospective

Outcome Measure:

To compare the detection rate of premalignant lesions(intestinal metaplasia, gastric atrophy, dysplasia) and early neoplasia of stomach between combined AFI/NBI endoscopy versus standard endoscopy

Outcome Description:

The purpose of this study is to prospectively evaluate this combined imaging modality for detection of high risk gastric lesions and early cancers by comparing it with standard videoendoscopy in a randomized fashion.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jimmy BY So, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore

Authority:

Singapore: Domain Specific Review Boards

Study ID:

DSRB D/07/163

NCT ID:

NCT01132534

Start Date:

June 2007

Completion Date:

April 2008

Related Keywords:

  • Gastric Cancer
  • OGD
  • NBI
  • AFI
  • Videoendoscopy
  • Narrow Band Imaging
  • Autofluorescence Imaging
  • Stomach Neoplasms

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