A Randomized Study Comparing Autofluorescence Imaging(AFI) Followed by Narrow Band Imaging(NBI) With Videoendoscopy for the Detection of High Risk Lesions of Stomach (CAFBI)

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01132534
First received: May 26, 2010
Last updated: June 15, 2010
Last verified: May 2010
  Purpose

Videoendoscopy is the standard tool for examination of gastrointestinal tract. However, precancerous lesions and early gastric cancer can be easily missed by routine videoendoscopy. Autofluorescence Imaging (AFI) and Narrow band imaging (NBI) are 2 new imaging systems used in endoscopy which are recently developed. AFI based on the presence of natural tissue fluorescence on the gastrointestinal tract. By computation of the difference in the reflecting images, the system can reveal early cancers that are not detectable by standard endoscopy. NBI is a high resolution imaging using lights with narrowed wavelength range, which able to enhance the fine structure of the mucosa. Recent studies suggested combined AFI and NBI can improve the detection of early esophageal and gastric cancers.

The investigators are conducting a prospective randomized cross-over study to compare the accuracy between this combined AFI/NBI imaging with standard videoendoscopy in the detection of precancerous lesions and gastric cancer in a high risk population inSingapore. The investigators hypothesis is that this new combined imaging system improves the investigators detection of high risk lesions of stomach.


Condition Phase
Gastric Cancer
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To assess the diagnostic accuracy AFI and NBI imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We aim to identify a method to improve our diagnosis of high risk gastric lesions in our population.


Enrollment: 64
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
SE then AFI/NBI
Patients will be randomised to be examined by standard videoendoscopy (SE) then combined AFI/NBI during the esophagogastroduodenoscopy (EGD) examination at same setting.
AFI/NBI then SE
Patients will be randomised to be examined by combined AFI/NBI then standard videoendoscopy (SE) during the EGD examination at same setting.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The inclusion criteria of this study is based on our previous study "Dan YY, So JBY, Yeoh KG. Endoscopic screening for gastric cancer: Clin Gastroenterol Hepatol 2006;4:709-716." which showed that ethnic Chinese and aged 50 or above have increased risk of developing gastric cancer.

In another study "Zhu F, Yeoh KG, So JBY, et al. Risk factors associated with intestinal metaplasia, a gastric pre-malignant lesion, in a chinese cohort under surveillance for gastric cancer: AACR; L.A. 2007 April" which is still ongoing, showed that the prevalence of intestinal metaplasia, a precancerous gastric lesion, is about 35% in this high risk population. Our sample size calculation is based on this finding and other relevant literature.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132534

Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Jimmy BY So, MBChB National University Hospital, Singapore
  More Information

No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A/Prof Jimmy So, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01132534     History of Changes
Other Study ID Numbers: DSRB D/07/163
Study First Received: May 26, 2010
Last Updated: June 15, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
OGD
NBI
AFI
Videoendoscopy
Narrow Band Imaging
Autofluorescence Imaging

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 30, 2014