Choledochoscopy Multicenter Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-12-30

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.

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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.

Conditions

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Pancreatico-biliary Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SpyGlass Choledochoscopy procedure

Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder

Choledochoscopy using Digital Spyglass

Intervention Type PROCEDURE

Choledochoscopy using Digital Spyglass during Endoscopy

Interventions

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Choledochoscopy using Digital Spyglass

Choledochoscopy using Digital Spyglass during Endoscopy

Intervention Type PROCEDURE

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