An interventional study of EYEMAX® cholangioscopy system and SPYGLASS™ DS system in Cholangiocarcinoma and Biliary Stricture, sponsored by David KARSENTI. Not yet recruiting. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by David KARSENTI · Not applicable, Interventional, and Diagnostic
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
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Exclusion Criteria:
Device: EYEMAX® cholangioscopy system
Device: SPYGLASS™ DS 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.
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.
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 year
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 year
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 year
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 year
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 year
Percentage of technical failures during cholangioscopy-guided biopsy procedures
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.
Time frame: Periprocedural
Diagnostic yield of additional biliary sampling techniques
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.
Time frame: Through study completion, an average of 1 year
Number of participants with procedure-related adverse events
Procedure-related adverse events include abdominal pain, acute pancreatitis, cholangitis, cholecystitis, hepatic abscess, perforation, bleeding, and death.
Time frame: Up to Day 30
Mean duration of cholangioscopy-guided biopsy procedures
The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems.
Time frame: Periprocedural
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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