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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
EYEMAX® cholangioscopy system
DeviceCholangioscopy-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.
SPYGLASS™ DS system
DeviceCholangioscopy-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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech).Experimental treatment 1 intervention
Group B: Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific).Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies
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.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Positive diagnostic yield of all eight cholangioscopy-guided biopsies
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.
Time frame
Through study completion, an average of 1 year2
Histological cellularity classification of cholangioscopy-guided biopsy specimens
Biopsy specimen cellularity will be assessed by expert gastrointestinal pathologists and classified into four predefined categories: acellular, low abundance, satisfactory abundance, or rich abundance.
Time frame
Through study completion, an average of 1 year3
False negative rate of cholangioscopy-guided biopsies
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.
Time frame
Through study completion, an average of 1 year4
Negative predictive value of cholangioscopy-guided biopsies
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.
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
David KARSENTI
Lead sponsor
Société Française d'Endoscopie Digestive
Sponsor institution
Source ClinicalTrials.gov
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