Early gastric cancer and colorectal neoplasm
Conditions
Interventions
1. pCLE 2. Intravenous fluorescene administration on pCLE
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, A patient with eary gastric cancer or colorectal neoplasm who is going to undergo endoscopic treatment or surgery. 2, Obtained written informed concent. 3, Fulfilled all of the laboratory data mentioned below within 60 days before enrollment. WBC =>3,000/mm3 Hb =>8.0g/dl Plt =>100,000 T.BIl <=2.0mg/dl AST(GOT) <=100 IU/l ALT (GPT) <=100 IU/l Cre <=1.5 mg/dl
Exclusion criteria
Exclusion criteria: Those who have comorbidities or clinical issue mentioned below are excluded; 1. Severe chronic anemia or thrombocytopenia which is not tolerable for endodscopic treatment or surgery 2. Allergy for fluorescene 3. Phaeochromocytoma, malignany hypertention or severe heart failure within 3 months 4. Uncontrolled diabetes mellitus 5. Severe pulmonary fibrosis or interstitial pneumonia 6. Uncontrolled infection 7. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achieve effective histological prediction such as malignancy, histological type and lateral tumor extention of gastrointestinal neoplasm by pCLE | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirm safety of fluorescene for pCLE in Japanese patients | — |
Countries
Japan
Contacts
Public ContactSeiichiro Abe
National Cancer Center Hospital Endoscopy Division
Outcome results
None listed