EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis

Starting soon · Not applicable

Conditions studied: Cholangiocarcinoma, Biliary Stricture

In brief

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.

Key facts

Study ID

NCT07620080

Run by

David KARSENTI

People needed

120

Starts

2026-09-01

Expected to finish

2030-09-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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