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

NCT01132534 | Completed DMC

• 1 other identifier: DSRB D/07/163
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer

Keywords

OGD; NBI; AFI; Videoendoscopy; Narrow Band Imaging; Autofluorescence Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• To assess the diagnostic accuracy AFI and NBI imaging

  6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Related Publications (1)

• 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.

  PMID: 23996468 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jimmy BY So, MBChB

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: June 16, 2010

Record last verified: 2010-05