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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031230238

Enrollment

Registered

2023-07-19

Start date

2023-07-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary stricture Biliary stricture

Interventions

Requires intravenous fluorescein for pCLE examination.

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 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

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 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

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

Measure

Time frame

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

—

Contacts

Public ContactYuki Tanisaka

Saitama Medical University International Medical Center

tanisaka@saitama-med.ac.jp+81-42-984-4111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026