New Kid on the Block: Development of a Partially Disposable System for Cholangioscopy

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History and evolution of cholangioscopy

Cholangioscopy allows for direct visualization of the bile duct using a miniature endoscope. It was first performed more than 60 years ago during surgical open bile-duct exploration for intraoperative localization of stones.1 Early diagnostic and therapeutic cholangioscopy was performed through either a surgically created or percutaneous biliary access.2, 3, 4, 5, 6, 7 Duodenoscope-assisted retrograde cholangioscopy with the mother-daughter system, as we know it, was first performed in the

Limitations of cholangioscopy before SpyGlass

Despite the availability of cholangioscopes, direct visualization of the pancreatobiliary system for diagnosis and therapy has not been widely applied in clinical practice thus far because of technical and technological limitations. These limitations, including suboptimal functionality and lack of user-friendliness of the available systems, have confined its use to select academic centers. For example, these cholangioscopy systems required 2 trained operators; 1 physician to handle the “mother”

SpyGlass Direct Visualization System features and description

Although the clinical value of optically guided biliary diagnosis and intervention was obvious, failure to overcome these technical handicaps limited advancement in this field. The SpyGlass Direct Visualization System (SDVS) was designed to address many of these issues by being the first single-use direct visualization system requiring only 1 physician operator, featuring dedicated irrigation and therapeutic channels, and providing 4-way steerability in a sturdy 4-lumen single-use catheter.

The

Technique for using the SpyGlass system in cholangioscopy

The cholangioscopy procedure using the SpyGlass System is performed by a single operator, by strapping the SADC to the handle of the duodenoscope just below the operating channel (see Fig. 2). In this configuration, the endoscopist controls the tip deflection wheels of both the duodenoscope and the SC visualization system with the right hand. The physician's left hand holds the duodenoscope to stabilize both systems and to torque the duodenoscope as needed. Preloading the SDVP into the optic

Preclinical study

The initial studies with SpyGlass helped to define the design and later verified safety and efficacy. During preclinical characterization, the SDVS was evaluated by bench simulation and porcine model experiments.15 The capabilities of the SpyGlass System for direct access, visualization, and biopsy in all quadrants were compared with those of a control fiberoptic choledochoscope with 2-way deflection (CHF-BP30; Olympus America Inc, Center Valley, PA) using an innovative bench simulator, with

First human use

Results from the first human use series provided the first clinical evidence that the SpyGlass System is safe and technically feasible.16 Consecutive SpyGlass examinations were performed in 35 patients undergoing ERCP at 2 centers. Indications for peroral cholangioscopy included indeterminate strictures, indeterminate filling defects, EHL stone therapy, evaluation of cystic lesions, and gallbladder stenting. The rate of procedural success was 91%; access to some areas of interest was precluded

SpyGlass registry

The largest case series on cholangioscopy has been completed. A 15-center international registry has documented the performance and utility of peroral cholangioscopy using the SpyGlass System in 297 patients requiring the procedure for stone therapy or investigation of suspected biliary pathology.17, 18, 19 Twelve-month follow-up data will be completed on the registry patients by April 2009. Interim results from this registry (N = 296) were presented at Digestive Disease Week in San Diego on

Other applications of SpyGlass

SpyGlass cholangioscopy has been reported to be superior to cholangiography in demonstrating anastomotic patency in liver transplant recipients.20 SpyGlass was used successfully to enter the cystic duct for guidewire placement and gallbladder stenting in a patient with pretransplant cirrhosis and symptomatic cholelithiasis who had previously failed multiple attempts to cannulate the cystic duct for gallbladder stenting at ERCP.16 Similarly, the system was used to place a guidewire across a

Future

The SDVS offers several unique features, including a single-operator design, 4-way tip deflection, and dedicated irrigation channels, which conventional cholangioscopes do not have. However, there are opportunities to improve this system. The most obvious need is for improved image quality. The fiberoptic images of the current SDVS are inferior in quality to digital images routinely acquired in the gastrointestinal tract with standard video endoscopes.25 Although fiberoptic images are

Acknowledgments

The authors would like to thank Boston Scientific Corporation for providing the figures used in this article.

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  • Cited by (25)

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