Choledochoscopy Multicenter Registry

Study Overview
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Brief Summary
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The purpose of this registry is to record information and evaluate the impact of SpyGlassTM Direct Visualization System for choledochoscopy on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by SpyGlass. This multi-center registry has been initiated: To document the impact of SpyGlass Choledochoscopy in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies. To assess the sensitivity, specificity, accuracy, technical feasibility, safety and cost effectiveness of SpyGlass and compare it to other diagnostic modalities.

Detailed Description
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Our institution performs therapeutic Interventional Endoscopy in around 750-1000 patients a year. During these interventional procedures, advanced and emerging imaging techniques including choledochoscopy, choledochopancreatoscopy, confocal endomicroscopy, chromoendoscopy, narrow band imaging, etc. are conducted for presumptive or definitive diagnoses in some of the patients suffering pancreatico-biliary disorders; including malignancies. Early and accurate diagnosis is necessary to improve the prognosis for pancreatic cancer or cholangiocarcinoma. Initial studies have shown that advanced imaging including confocal microendoscopy may majorly impact the clinical management of patients by providing accurate diagnosis early on. Choledochoscopy is used for microendoscopic visualisation of lumen and mucous membrane, for diagnosis, classification and therapy of abnormally functioning gall-bladder and pancreatic systems. New refinements have allowed for single user direct imaging with endobiliary biopsy. SpyGlassTM Direct Visualization System (Boston Scientific, Natick, MA) is a platform designed to enhance diagnostic accuracy during ERCP (Endoscopic Retrograde Cholangiopancreatography) and allowing guided biopsy. It is an FDA approved instrument with the ability of performing cholangiopancreatoscopy by a single endoscopist during ERCP. A 1.2 mm working channel exists within the Spyglass system allowing for instrument access to the biliary or pancreatic tree. Advanced Endoscopists at various centers in the U.S, and outside U.S., use Choledochoscopy with SpyGlass to assist in the confirmation of diagnosis in patients having Billiary lesions. However, there is little data and thus neglibible evidence regarding the agreement of SPY interpretation within doctors. However, advanced endoscopists have only recently started to employ the SpyGlassTM Direct Visualization System for single operator choledochoscopy. Hence we lack enough data to accurately evaluate the sensitivity, specificity, accuracy, technical feasibility, safety and cost effectiveness of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate imaging techniques for biliary and pancreatic disorders and improve clinical management of patients. The purpose of this registry is to record information and evaluate the impact of SpyGlassTM Direct Visualization System for choledochoscopy on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by SpyGlass.

Official Title
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Choledochoscopy For Diagnosing Pancreatico-Biliary Disorders: A Multicenter Registry

Conditions
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Pancreatico-biliary Disorder

Intervention / Treatment
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* Procedure: Choledochoscopy using Digital Spyglass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder Above 18 years of age Exclusion Criteria: Any patient who has not undergone choledochoscopy for pancreatico-biliary disorders Below 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SpyGlass Choledochoscopy procedure<br>Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder | Procedure: Choledochoscopy using Digital Spyglass<br>* Choledochoscopy using Digital Spyglass during Endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Management | Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable (followup at a year for confirmed diagnosis if tissue results are negative or indeterminate). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile | Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events. | 30 days post procedure |