EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis
EYE/SPY
Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2026
CompletedFirst Posted
Study publicly available on registry
June 2, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
Study Completion
Last participant's last visit for all outcomes
September 1, 2030
June 2, 2026
May 1, 2026
3 years
May 19, 2026
May 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
The positive diagnostic yield will be assessed for the first four biopsies obtained under cholangioscopy in patients with adenocarcinomatous biliary strictures. This rate will be defined as the ratio between the number of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies and the total number of confirmed adenocarcinomatous biliary strictures.
Through study completion, an average of 1 year
Secondary Outcomes (8)
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
Through study completion, an average of 1 year
Histological cellularity classification of cholangioscopy-guided biopsy specimens
Through study completion, an average of 1 year
False negative rate of cholangioscopy-guided biopsies
Through study completion, an average of 1 year
Negative predictive value of cholangioscopy-guided biopsies
Through study completion, an average of 1 year
Percentage of technical failures during cholangioscopy-guided biopsy procedures
Periprocedural
- +3 more secondary outcomes
Study Arms (2)
Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).
EXPERIMENTALCholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).
ACTIVE COMPARATORInterventions
Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the EYEMAX® working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.
Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS cholangioscopy system (Boston Scientific) during ERCP under general anesthesia. Following biliary cannulation and guidewire passage across the stricture, two series of four targeted biopsies are obtained using the dedicated biopsy forceps through the SPYGLASS™ DS working channel. Additional diagnostic sampling procedures, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling when clinically indicated, may also be performed according to local practice.
Eligibility Criteria
You may qualify if:
- \. Adult patients aged 18 to 84 years
- \. Patients requiring ERCP with cholangioscopy-guided biopsy for biliary stricture
- \. Absence of a mass easily accessible to EUS-guided fine needle aspiration
- \. ASA physical status 1-3
- \. No participation in another clinical trial
- \. Written informed consent obtained
- \. Patient affiliated with a social security system or equivalent
You may not qualify if:
- \. Lithiasic biliary obstruction
- \. Patients younger than 18 years
- \. ASA 4 or ASA 5 patients
- \. Pregnant or breastfeeding women
- \. Coagulation disorders preventing biopsy procedures
- \. Surgical anatomy preventing papillary access
- \. Patients unable to provide informed consent
- \. Upper gastrointestinal obstruction
- \. Intolerance to endoscopy
- \. Severe cardiopulmonary disease
- \. Acute pancreatitis or severe cholangitis
- \. Severe contrast agent allergy
- \. Patients under legal protection measures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David KARSENTIlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label with blinded pathology review
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator, Medical doctor
Study Record Dates
First Submitted
May 19, 2026
First Posted
June 2, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
September 1, 2030
Last Updated
June 2, 2026
Record last verified: 2026-05