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Not yet recruiting NCT07620080

EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis

No phase Interventional Cholangiocarcinoma Biliary Stricture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EYEMAX® cholangioscopy system, SPYGLASS™ DS system.
Who it may be relevant to
Registry conditions: Cholangiocarcinoma, Biliary Stricture. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 indic
  • 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 sampli

Primary outcome measures

  • Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (8)
  • Positive diagnostic yield of all eight cholangioscopy-guided biopsies [Time frame: Through study completion, an average of 1 year]
  • Histological cellularity classification of cholangioscopy-guided biopsy specimens [Time frame: Through study completion, an average of 1 year]
  • False negative rate of cholangioscopy-guided biopsies [Time frame: Through study completion, an average of 1 year]
  • Negative predictive value of cholangioscopy-guided biopsies [Time frame: Through study completion, an average of 1 year]
  • Percentage of technical failures during cholangioscopy-guided biopsy procedures [Time frame: Periprocedural]
  • Diagnostic yield of additional biliary sampling techniques [Time frame: Through study completion, an average of 1 year]
  • Number of participants with procedure-related adverse events [Time frame: Up to Day 30]
  • Mean duration of cholangioscopy-guided biopsy procedures [Time frame: Periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07620080 · SFED-160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗