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EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis (EYE/SPY)

26. mai 2026 oppdatert av: David KARSENTI

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).
Enhet: 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.
Aktiv komparator: Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
Tidsramme: 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.
Through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
Tidsramme: 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.
Through study completion, an average of 1 year
Histological cellularity classification of cholangioscopy-guided biopsy specimens
Tidsramme: 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.
Through study completion, an average of 1 year
False negative rate of cholangioscopy-guided biopsies
Tidsramme: 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.
Through study completion, an average of 1 year
Negative predictive value of cholangioscopy-guided biopsies
Tidsramme: 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.
Through study completion, an average of 1 year
Percentage of technical failures during cholangioscopy-guided biopsy procedures
Tidsramme: 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.
Periprocedural
Diagnostic yield of additional biliary sampling techniques
Tidsramme: 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.
Through study completion, an average of 1 year
Number of participants with procedure-related adverse events
Tidsramme: Up to Day 30
Procedure-related adverse events include abdominal pain, acute pancreatitis, cholangitis, cholecystitis, hepatic abscess, perforation, bleeding, and death.
Up to Day 30
Mean duration of cholangioscopy-guided biopsy procedures
Tidsramme: Periprocedural
The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems.
Periprocedural

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

David KARSENTI

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. september 2030

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. mai 2026

Først lagt ut (Faktiske)

2. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SFED-160

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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