CompletedNot Applicable

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

64 participantsStarted 2007-06

Plain-language 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. 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age \>=50
. Ethnic Chinese
. Presenting symptom - dyspepsia

Exclusion criteria

. Patients who are unable to give an informed consent.
. Patients with previous surgery of the stomach.
. Patients presented with active gastrointestinal bleeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT01132534

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2007-12

View on ClinicalTrials.gov More Gastric Cancer trials