Biliary stricture Biliary stricture
Conditions
Sponsors
Tanisaka Yuki
Ryozawa Shomei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biliary stricture which is suspected by abdominal echo, CT scan, or MRI 2. Needs for detailed inspection of biliary stricture 3. Impossible to definitive diagnosis by cholangioscopy-guided biopsy 4. 20 years old or older 5. ECOG performance status score (PS) 0-2 6. Informed consent has been obtained 7. No gastrectomy except for Billroth I gastrectomy
Exclusion criteria
Exclusion criteria: 1. Difficult for biopsy due to comorbidity 2. Poor general condition 3. Impossible to discontinue the antithrombotic agents 4. Allergy to fluorescein 5. Patients with pheochromocytoma, pernicious hypertension, severe heart failure,or myocardial infarction within 3 months 6. Patients with poorly controlled diabetes mellitus 7. Patients with severe cerebral blood flow disorders 8. Patients with cirrhosis 9. Patients of childbearing potential, pregnant or nursing women 10. Post surgically altered anatomy such as gastrectomy(Billroth I I or Roux-en-Y) or hepaticojejunostomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cases where malignant biliary strictures, which were difficult to diagnose using direct cholangioscopic biopsy, were accurately diagnosed as malignant using pCLE under the direct view of cholangioscopy . | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic yield of pCLE under the direct view of cholangiography (sensitivity, specificity, positive predictive value, negative predictive value). Diagnostic yield of cholangiography. Diagnostic yield of cholangioscopy findings. Diagnostic yield of cholangioscopy-guided biopsy. Characteristics of biliary strictures diagnosed in this study Safety of intravenous fluorescein. Adverse event rate in whole procedure. | — |
Contacts
Public ContactYuki Tanisaka
Saitama Medical University International Medical Center
Outcome results
None listed