gastric cancer, gastric adenoma
Conditions
Interventions
Study drug administration, endoscopy
Sponsors
Isomoto Hajime
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients scheduled for endoscopic resection of differentiated gastric cancer or gastric adenoma in the stomach after HP infection or eradication 2) Patients of over 18 years at the time of consent 3) Patients with ECOG Performance Status 0 or 1 4) Patients with preserved function of major organs such as heart, lungs, liver, and kidney. In particul ar, the liver, kidneys, and blood coagulation capacity must meet the following criteria based on blood tests at screening. -Liver: bilirubin 45ml/min -Blood coagulability: PT INR and APTT values judged acceptable by the study investigator to undergo endoscopic examination. 5) Females of reproductive potential and males who are willing to use a highly effective contracepti ve method (Pearl index <1) during the study period. (6) Patients who have given free and voluntary written consent to the study
Exclusion criteria
Exclusion criteria: 1) Patients with a history of gastric surgery 2) Patients scheduled on endoscopic resection for local recurrence after endoscopic treatment 3) Patients with active cancer of other organs 4) Patients with hypersensitivity to porphyrin analogues 5) Patients with a history of photosensitivity 6) Patients with serious infections 7) Patients with contraindications to gastrointestinal endoscopy 8) Pregnant or lactating women, or women of childbearing potential 9) Other patients deemed ineligible by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of fluorescence with 5-ALA-PEI for lesions already noted | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of lesions newly detected by 5-ALA-PEI alone and its frequency in relation to the total number of lesions 2) Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, false positive value, and false negative value) of 5-ALA-PEI for lesions newly detected in this study 3) Detection rate of fluorescence by 5-ALA-PEI in all lesions 4) Difference in detection rate of 5-ALA-PEI when all lesions are divided into those currently infected with Helicobacter pylori and those after Helicobacter pylori eradication 5) Verification of the relationship between fluores cence intensity (strong positive/weak positive/neg ative) and histopathological type 6) Concordance rate of fluorescence diagnosis between 5-ALA-PEI performing physicians and central judgment committee members 7) Adverse events | — |
Contacts
Public ContactHiroki Kurumi
Tottori University Hospital
Outcome results
None listed