Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic .

Diagnostic Accuracy of ERCP-guided Versus Cholangioscopy-guided Tissue Acquisition in Patients With Indeterminate Biliary Strictures Suspected to be Intrinsic - a Randomized Controlled Study

Primary Objective: To assess the diagnostic accuracy of cholangioscopy-based assessment using SpyDS technology compared to cholangiography-based assessment using ERCP-guided biopsy and brushing in patients with indeterminate biliary strictures in the setting of cholangiocarcinoma.

Study Design : Prospective,multi-center, randomized controlled, Post market Study (PMS)

Two groups:

• Control arm - ERCP arm: ERCP impression and ERCP-guided brushing and biopsy
• Study arm - Cholangioscopy arm: SpyDS impression and SpyDS-guided SpyBite biopsy Randomization 1:1 ratio. Primary Endpoint: Diagnostic accuracy of cholangioscopy or cholangiography assessed at 6 months after initial ERCP procedure
• Malignancy will be determined by cytology or histology on tissue sampling during the index procedure, or from other tissue acquisition or surgical specimen histopathology up to 6 months after the index procedure.
• Overall diagnostic accuracy.
• The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure.
• Overall diagnostic accuracy will be assessed for
• ERCP impression of malignancy
• ERCP-guided brushing and biopsies separately and combined*
• SpyDS impression of malignancy
• SpyBite biopsies
• In case of discordant results, the following will be followed for the combined pathology/cytology measure:
• If at least one is malignancy, then combine metric is malignant
• If both are benign or one is benign and one is non-diagnostic, then combined metric is benign
• If both are non-diagnostic, then combined metric is non-diagnostic

Secondary Endpoints:

1. Occurrence and severity of procedure related serious adverse events from index procedure through 30 days after procedure. Hospitalization and ICU admissions
2. Technical success of procedure defined as ability to collect tissue deemed adequate for cytology or histology. Indeterminate or equivocal or atypical or non-conclusive cytology or histology will be considered failures to this endpoint.
3. Correlation between impression of malignancy and cytopathology in the ERCP arm compared to the Cholangioscopy arm.
4. Additional diagnostic accuracy metrics: Sensitivity, specificity, positive predictive value, negative predictive value. The assessed strictures will be considered benign if there was no confirmation of malignancy by 6 months after the index procedure.
5. Impact of ERCP or cholangioscopy on patient management.
6. Need for additional diagnostic procedures beyond the index procedure.
7. Procedural measures: Type and number of devices used,
8. Duration of procedure from duodenoscope in to duodenoscope out

Inclusion Criteria:

1. Age 18 or older.
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
3. Biliary obstructive symptoms
4. Indeterminate biliary stricture suspected to be intrinsic based on prior imaging

Exclusion Criteria:

1. Contraindications for endoscopic techniques
2. Prior ERCP for assessment of indeterminate biliary stricture
3. Pancreatic head mass identified on prior non-invasive imaging and thought to be the cause of the biliary obstructive symptoms