Biliary Stricture, Cholangiocarcinoma
Conditions
Keywords
Cholangioscopy, ERCP, EYEMAX, SpyGlass DS, Biliary biopsy, Cholangiocarcinoma diagnosis
Brief summary
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.
Interventions
DEVICEEYEMAX® 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.
DEVICESPYGLASS™ 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.
Sponsors
David KARSENTI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Open Label with blinded pathology review
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of positive pathological diagnoses obtained from the first four cholangioscopy-guided biopsies | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive diagnostic yield of all eight cholangioscopy-guided biopsies | 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. |
| Histological cellularity classification of cholangioscopy-guided biopsy specimens | 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. |
| False negative rate of cholangioscopy-guided biopsies | 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. |
| Negative predictive value of cholangioscopy-guided biopsies | 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. |
| Percentage of technical failures during cholangioscopy-guided biopsy procedures | 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. |
| Diagnostic yield of additional biliary sampling techniques | 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. |
| Number of participants with procedure-related adverse events | Up to Day 30 | Procedure-related adverse events include abdominal pain, acute pancreatitis, cholangitis, cholecystitis, hepatic abscess, perforation, bleeding, and death. |
| Mean duration of cholangioscopy-guided biopsy procedures | Periprocedural | The duration required to complete the eight cholangioscopy-guided biopsies will be measured and compared between the two cholangioscopy systems. |
Contacts
CONTACTDavid KARSENTI, MD
CONTACTMORENO MAIRA, PhD
Outcome results
None listed