EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis (EYE/SPY)

David KARSENTI

Status: Begins enrollment in 2 months

Conditions: Biliary Stricture; Cholangiocarcinoma

Treatments: Device: EYEMAX® cholangioscopy system; Device: SPYGLASS™ DS system

Study type: Interventional

Funder types: Other

Identifiers

NCT07620080

SFED-160

Details and patient eligibility

About

Cholangiocarcinoma remains difficult to diagnose because of the limited sensitivity of currently available endobiliary sampling techniques. Cholangioscopy-guided biopsies performed with the SPYGLASS™ DS system have improved tissue acquisition compared with conventional brushing techniques, but diagnostic sensitivity remains suboptimal, partly because of the small diameter of the dedicated biopsy forceps.

The EYEMAX® cholangioscopy system has a larger working channel, potentially allowing the use of larger biopsy forceps and improved tissue acquisition. This multicenter randomized study aims to compare the diagnostic performance of EYEMAX® versus SPYGLASS™ DS for the diagnosis of malignant biliary strictures.

The primary objective is to compare the positive diagnostic yield of the first four cholangioscopy-guided biopsies obtained with each system in patients with adenocarcinomatous biliary strictures.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Adult patients aged 18 to 84 years
• 2. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture
• 3. Absence of a mass easily accessible to EUS-guided fine needle aspiration
• 4. ASA physical status 1-3
• 5. No participation in another clinical trial
• 6. Written informed consent obtained
• 7. Patient affiliated with a social security system or equivalent

Exclusion criteria

• 1. Lithiasic biliary obstruction
• 2. Patients younger than 18 years
• 3. ASA 4 or ASA 5 patients
• 4. Pregnant or breastfeeding women
• 5. Coagulation disorders preventing biopsy procedures
• 6. Surgical anatomy preventing papillary access
• 7. Patients unable to provide informed consent
• 8. Upper gastrointestinal obstruction
• 9. Intolerance to endoscopy
• 10. Severe cardiopulmonary disease
• 11. Acute pancreatitis or severe cholangitis
• 12. Severe contrast agent allergy
• 13. Patients under legal protection measures

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).

Experimental group

Treatment:

Device: EYEMAX® cholangioscopy system

Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).

Active Comparator group

Treatment:

Device: SPYGLASS™ DS system