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NCT Number: NCT07620080

EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis

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.

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Biliary Stricture Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EYEMAX® cholangioscopy system

Device

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.

SPYGLASS™ DS system

Device

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.

Primary outcomes

  1. Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Positive diagnostic yield of all eight cholangioscopy-guided biopsies

    Time frame: Through study completion, an average of 1 year

    This rate will be defined as the proportion of positive pathological diagnoses obtained from all eight cholangioscopy-guided biopsies among all confirmed adenocarcinomatous biliary strictures.

  2. Histological cellularity classification of cholangioscopy-guided biopsy specimens

    Time frame: Through study completion, an average of 1 year

    Biopsy specimen cellularity will be assessed by expert gastrointestinal pathologists and classified into four predefined categories: acellular, low abundance, satisfactory abundance, or rich abundance.

  3. False negative rate of cholangioscopy-guided biopsies

    Time frame: Through study completion, an average of 1 year

    The false negative rate will be defined as the proportion of patients with negative biopsy results despite a final diagnosis of adenocarcinomatous biliary stricture confirmed during follow-up.

  4. Negative predictive value of cholangioscopy-guided biopsies

    Time frame: Through study completion, an average of 1 year

    Negative predictive value will be calculated as the proportion of patients with negative biopsy results who do not have adenocarcinomatous biliary strictures at final diagnosis.

  5. Percentage of technical failures during cholangioscopy-guided biopsy procedures

    Time frame: Periprocedural

    Technical failure will be defined as the inability to access the biliary stricture with the cholangioscope or the inability to obtain biopsy material using the dedicated biopsy forceps.

  6. Diagnostic yield of additional biliary sampling techniques

    Time frame: Through study completion, an average of 1 year

    The diagnostic yield of additional biliary sampling techniques, including biliary brushing, fluoroscopy-guided biopsies, bile aspiration cytology, and EUS-guided sampling, will be evaluated as the proportion of positive pathological diagnoses obtained using each technique.

  7. Number of participants with procedure-related adverse events

    Time frame: Up to Day 30

    Procedure-related adverse events include abdominal pain, acute pancreatitis, cholangitis, cholecystitis, hepatic abscess, perforation, bleeding, and death.

  8. Mean duration of cholangioscopy-guided biopsy procedures

    Time frame: Periprocedural

    The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems.

Study contacts

Contact information is provided by the study sponsor or research team.

David KARSENTI, MD

CONTACT

[email protected]

+33 1 43 96 78 50

MORENO MAIRA, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

David KARSENTI

Other

Registry information

Official study title

Multicenter Study on the Quality of Biliary Biopsies: EYEMAX® vs SPYGLASS™ DS

Acronym: EYE/SPY

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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