MedTrace Logo

EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis

NCT07620080 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

EYEMAX® cholangioscopy system

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.

DEVICE

SPYGLASS™ DS system

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.

Sponsors & Collaborators

  • David KARSENTI

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2030-09-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620080 on ClinicalTrials.gov