Gastric CancerCAFBINCT01132534
A Randomized Study Comparing Autofluorescence Imaging(AFI) Followed by Narrow Band Imaging(NBI) With Videoendoscopy for the Detection of High Risk Lesions of Stomach
An observational study of Gastric Cancer, run by National University Hospital, Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Apr 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age >=50
- Ethnic Chinese
- Presenting symptom - dyspepsia
Who cannot join
- Patients who are unable to give an informed consent.
- Patients with previous surgery of the stomach.
- Patients presented with active gastrointestinal bleeding.
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer
- Keywords
- OGD, NBI, AFI, Videoendoscopy, Narrow Band Imaging, Autofluorescence Imaging
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 6 months
Secondary outcomes (1)
To assess the diagnostic accuracy AFI and NBI imaging
We aim to identify a method to improve our diagnosis of high risk gastric lesions in our population.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Investigators
- Jimmy BY So, MBChB, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132534
- Sponsor's protocol ID
- DSRB D/07/163
- Acronym
- CAFBI
- Status last verified
- May 2010
- First submitted
- 26 May 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
So J, Rajnakova A, Chan YH, Tay A, Shah N, Salto-Tellez M, Teh M, Uedo N. Endoscopic tri-modal imaging improves detection of gastric intestinal metaplasia among a high-risk patient population in Singapore. Dig Dis Sci. 2013 Dec;58(12):3566-75. doi: 10.1007/s10620-013-2843-2. Epub 2013 Sep 1.
PubMed 23996468
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01132534
- Acronym / sponsor ID
- CAFBI / DSRB D/07/163
- Conditions
- Gastric Cancer
- Keywords
- OGD, NBI, AFI, Videoendoscopy, Narrow Band Imaging, Autofluorescence Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age >=50
- Ethnic Chinese
- Presenting symptom - dyspepsia
Key exclusion criteria (3 listed)
- Patients who are unable to give an informed consent.
- Patients with previous surgery of the stomach.
- Patients presented with active gastrointestinal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
To assess the diagnostic accuracy AFI and NBI imaging
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2010.
- Derived from this study: PubMed 23996468So J, Rajnakova A, Chan YH, Tay A, Shah N, Salto-Tellez M, Teh M, Uedo N. Endoscopic tri-modal imaging improves detection of gastric intestinal metaplasia among a high-risk patient population in Singapore. Dig Dis Sci. 2013 Dec;58(12):3566-75. doi: 10.1007/s10620-013-2843-2. Epub 2013 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy BY So, MBChB principal investigator
National University Hospital, Singapore
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by National University Hospital, Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01132534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2010.