Clinical trial · Interventional
EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis
Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EYEMAX® cholangioscopy system | Device | — | UNRESOLVED |
| SPYGLASS™ DS system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).
- interventionNames
- Device: EYEMAX® cholangioscopy system
- type
- ACTIVE_COMPARATOR
- label
- Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).
- interventionNames
- Device: SPYGLASS™ DS system
Primary outcomes (1)
- measure
- Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 84 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available