Probe-based confocal laser endomicroscopy(pCLE) under the direct view of cholangioscopy for diagnosis of biliary stricture

Not Applicable

Recruiting

• Conditions: Biliary stricture

• Registration Number: JPRN-jRCTs031230238
• Lead Sponsor: Tanisaka Yuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

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 conventional ERCP using fluoroscopy
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility of pCLE using fluorescein by dripping and intravenous administration in patients with biliary stricture who was impossible to definitive diagnosis by conventional ERCP using fluoroscopy

Secondary Outcome Measures

Name	Time	Method
Safety of intravenous fluorescein.<br>Diagnostic yield of pCLE under the direct view of cholangiography after fluorescein dripping(sensitivity, specificity, positive predictive value, negative predictive value).<br>Diagnostic yield of pCLE under the direct view of cholangiography after intravenous fluorescein<br>Diagnostic yield of cholangiography.<br>Diagnostic yield of cholangioscopy findings.<br>Diagnostic yield of cholangioscopy-guided biopsy.<br>Adverse event rate in whole procedure.