gastric neoplastic benign lesions gastric neoplastic benign lesions
Conditions
Interventions
Confocal LASER Endoscopic examination using the fluorescent agent
fluorescent agent
Sponsors
Saito Yutaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for primary registration (registration for screening) 1)The patient who histologically diagnosed or suspected early gastric cancer by esophago-gastro-duodenoscopy (Biopsy revealed as Group 4 or 5) or Patient observed more than 40 weeks after endoscopic resection (EMR or ESD) for early gastric cancer 2)20 years old or older, and 79 years old under at the time of primary registration 3)ECOG performance status score 0-2 4)Written informed consent was taken from the patient himself or herself for registration to the clinical trial 5)No past medical history for gastrectomy 6)Laboratory data within 60 days before registration meets all the following conditions 1.White blood cell count =>3000 /mm3 2.Hemoglobin =>8.0g/dl 3.Platelet count =>100000 /mm3 4.Total bilirubin =<2.0mg/dl 5.AST(GOT)=<100 IU/l 6.ALT(GPT)=<100 IU/l 7.Serum creatinine =<1.5 mg/dl Inclusion criteria for secondary registration (definitive registration) 1)Patient with an gastric epithelial lesion before diagnosis
Exclusion criteria
Exclusion criteria: Exclusion criteria for primary registration (registration for screening) 1)Patient with comorbid disease that makes it difficult for biopsy from the gastric lesion (e.g. chronic hematologic disorder) 2)Patient who does not stop the antithrombotic treatment according to Guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment 3)Patient with allergy for fluorescein 4)Patient with pheochromocytoma, malignant hypertension, severe heart failure, or acute myocardial infarction within 3 months 5)Patient with uncontrollable diabetes 6)Patient with severe pulmonary fibrosis or active interstitial pneumonia 7)Patient with uncontrollable infectious disease 8)Patient who has possibility of the pregnancy, a pregnant woman, or patients during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| oninferiority of specificity of magnified narrow band imaging and superiority of non-magnified white light imaging using pCLE for gastric epithelial lesion without definitive diagnosis of neoplastic or non-neoplastic tumor in the diagnostic central review (off-line review). | — |
Secondary
| Measure | Time frame |
|---|---|
| Noninferiority of specificity, sensitivity, positive predictive value(PPV), negative predictive value(NPV), and accuracy of magnified narrow band imaging and superiority of non-magnified white light imaging using pCLE for gastric epithelial lesion without definitive diagnosis of neoplastic or non-neoplastic tumor in the diagnostic real-time diagnosis (on-site review). The ratio of adverse events of fluorescein using for pCLE examination. Noninferiority of sensitivity, specificity, positive predictive value(PPV), negative predictive value(NPV), and accuracy of magnified narrow band imaging and superiority of non-magnified white light imaging using pCLE for gastric epithelial lesion without definitive diagnosis of neoplastic or non-neoplastic tumor in the diagnostic central review (off-line review). The specificity of pCLE examination for negative margin of ESD with definitive diagnosis of gastric neoplasm in the real-time diagnosis (on-site review).The gold standard is the histological evaluation of specimens resected by ESD technique. | — |
Contacts
Public ContactHiroyuki Takamaru
National Cancer Center Hospital
Outcome results
None listed