cholangiocarcinoma
Conditions
Interventions
Period of implementation: 3 days Maximum observation period: 12 months A single dose of 5-ALA (5-ALA 20 mg / kg dissolved in 200 ml of water
dosage approved as an intraoperative diagnostic for brain tumor)
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Bile duct stenosis suspected of cholangiocarcinoma 2. Patients who obtained informed concent 3. 20 years of age or older
Exclusion criteria
Exclusion criteria: 1. Cases in ECOG performance status 4 2. Cases with serious complications in other organs 3. Cases who have difficulty in endoscopic approach via the ampulla of Vater 4. Cases under 20 years of age 5. Cases who don't give informed consent 6. Cases with hypersensitivity porphyrin related substances or its previous history 7. Cases with porphyria 8. Pregnant women or cases who may be pregnant 9. Other cases that the research responsibility (share) person judged inappropriate as the research subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy rate of diagnosis of cholangiocarcinoma by evalation of expression of protoporphyrinIX | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Technical success rate 2.Comparison between normal light, NBI observation and fluorescence observation for evalation of mucosal cancerous extension 3.Rate of complication 4.Rate of drug-related adverse event | — |
Countries
Japan
Contacts
Public ContactShinichiro Muro
Okayama University Hospital Depertment of Endoscopy
Outcome results
None listed