A single-center, prospective pilot study to elucidate the fluorescence diagnostic ability of 5-aminolevulinic acid for cholangiocarcinoma
Not Applicable
- Conditions
- cholangiocarcinoma
- Registration Number
- JPRN-UMIN000025915
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy rate of diagnosis of cholangiocarcinoma by evalation of expression of protoporphyrinIX
- Secondary Outcome Measures
Name Time Method 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