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

26 maj 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Periprocedural
The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems.
Periprocedural

Samarbetspartners och utredare

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Sponsor

David KARSENTI

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2029

Avslutad studie (Beräknad)

1 september 2030

Studieregistreringsdatum

Först inskickad

19 maj 2026

Först inskickad som uppfyllde QC-kriterierna

26 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • SFED-160

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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