Gastrointestinal (GI) lesions Digestive System
Conditions
Interventions
Patients will first be administered a mild sedative as used in conventional gastroscopic examinations. The upper GI tract will be carefully inspected under white light endoscopy. White light endoscopi
Sponsors
National Medical Research Council
National Research Foundation-Proof-of-Concept
Academic Research Fund from Ministry of Education
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is undergoing endoscopy for suspected or known GI lesions such as peptic ulcer, gastritis, intestinal metaplasia, dysplasia, gastric cancer, reflux oesophagitis, Barrett’s oesophagus or oesophageal cancer 2. The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study 3. The subject must be willing and able to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated 2. The subject with liver cirrhosis 3. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy 4. The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study 5. The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a five-day washout period before gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before gastroscopy. The subject’s physician or study co-investigator will exercise their clinical judgement to ensure subject’s safety 6. The subject is unwilling or unable to provide signed informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic sensitivity and specificity of near-infrared autofluorescence imaging and/or Raman spectroscopy for upper gastrointestinal (GI) lesions | — |
Secondary
| Measure | Time frame |
|---|---|
| Predicative sensitivity and specificity of near-infrared autofluorescence imaging and/or Raman spectroscopy for upper gastrointestinal (GI) lesions | — |
Countries
Singapore
Contacts
Public ContactKhek Yu Ho
Outcome results
None listed