Choledochoscopy Multicenter Registry

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.

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