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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholangioscopy-guided biliary biopsies performed using the EYEMAX® cholangioscope (Micro-Tech). | Experimental |
| |
| Cholangioscopy-guided biliary biopsies performed using the SPYGLASS™ DS system (Boston Scientific). | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYEMAX® cholangioscopy system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David KARSENTI, MD | Contact | +33 1 43 96 78 50 | karsenti.paris@gmail.com | |
| MORENO MAIRA, PhD | Contact | rechercheclinique@sfed.org |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Open Label with blinded pathology review
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| SPYGLASS™ DS system | Device | 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Periprocedural |
| D009369 | Neoplasms |