EYEMAX® Versus SPYGLASS™ DS for Biliary Stricture Diagnosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorDavid KARSENTI
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
1. Lithiasic biliary obstruction
2. Patients younger than 18 years
3. ASA 4 or ASA 5 patients
4. Pregnant or breastfeeding women
Trial design
Treatments tested in this trial
- EYEMAX® cholangioscopy system
- SPYGLASS™ DS system
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
David KARSENTI
Lead sponsor
Société Française d'Endoscopie Digestive
Sponsor institution
Source ClinicalTrials.gov