Cholangioscopy

Conventional Cholangioscopy

Developed in 1961, cholangioscopy (also known as intraductal endoscopy) is the examination of the bile ducts with the use of a fiberoptic endoscope for direct visualization of the biliary tree during an ERCP (Endoscopic Retrograde Cholangiopancreatography). A physician may choose to perform a cholangioscopy in the event that x-ray imaging from an ERCP is insufficient to make an adequate diagnosis, or therapeutic intervention requires direct visualization.

A conventional cholangioscopy procedure requires two endoscopists - one to operate the duodenoscope and a second to steer the cholangioscope and operate its working channel. The fragility of the optical fibers, and less invasive methods like ultrasound and CT, contributed to its decreased use. Peroral cholangioscopy (POCS) was not used in the diagnosis of biliary disease as a result of these technological difficulties.

Cholangioscopy with the SpyGlass® Direct Visualization System

The SpyGlass Direct Visualization System is one of the latest advancements in intraductal visualization during a cholangioscopy. The SpyGlass System is a single-operator system that allows not only optical viewing, but also optically guided biopsies and has been shown to be compatible with electrohydraulic lithotripsy (EHL).* The SpyGlass System is designed to allow the physician the ability to directly visualize the site of interest - whether it be a stricture, stones or an area of concern - vs. traditional non-direct visualization techniques such as x-ray.

Cholangioscopy with the SpyGlass System is performed by a single operator with the SpyScope® Access and Delivery Catheter, which is positioned just below the operating channel of the duodenoscope. This allows the endoscopist to control both the tip deflection wheels of the duodenoscope and the knobs of the SpyScope Catheter with the same hand. The physician's other hand holds the duodenoscope, which is inserted into the patient's mouth and navigated through the anatomy to a position in front of the papilla where a sphincterotomy may be performed as necessary.

At this point, the SpyGlass Probe is introduced into the SpyScope Access and Delivery Catheter. The bile duct is cannulated, and the SpyScope Catheter guides the SpyGlass Probe into the biliary tree. The SpyScope Catheter and SpyGlass Probe are maneuvered up to the desired area of interest within the duct for direct visualization. Additionally, selected ducts and branches of interest can be examined during repeated advancement and withdrawal of the system utilizing the four-way tip deflection. Two separate channels in the SpyScope Catheter allow for adequate irrigation to clear debris and aid in guiding both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the biliary system including the hepatic ducts. If necessary, the SpyBite® Biopsy Forceps or an EHL probe*, guided by the SpyScope Catheter, is introduced. At this point, an optically-guided biopsy can be taken or stones may be fragmented.

 

* Data on file, Boston Scientific. The SpyGlass System has been shown to be compatible with the Northgate® 1.9Fr Biliary Probe and the Northgate Autolith® Intracorporeal Electrohydraulic Lithotripsy iEHL Generator.

Northgate and Autolith are trademarks of Northgate Technologies, Inc.

References

¹ Kawai K, Nakajima M, Akasaka Y, Shimamotu K, Murakami K. A new endoscopic method: the peroral choledocho-pancreatoscopy [author’s translation]. Leber-Magen-Darm 1976; 6: 121-4.

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Intended Use

The SpyGlass Probe and Ocular are intended to provide direct visualization for examination for diagnostic and therapeutic applications during endoscopic procedures of the biliary system and hepatic ducts. For specific instructions on each of the SpyGlass Capital components, please refer to the Users Manuals for those components.

Contraindications

Contraindications associated with the use of the SpyGlass Probe and Ocular include:

• Patients for whom endoscopic procedures are medically contraindicated
• Patients for whom endoscopic retrograde cholangiopancreatography (ERCP) are medically contraindicated
• Any use other than those specifically outlined under the Indications for Use

Cautions and Warnings

The SpyGlass Probe and Ocular should only be used by or under the supervision of physicians thoroughly trained in ERCP procedures. A thorough understanding of the techniques, principles, clinical applications and risks associated with this procedure is necessary before using the device.

Rx Only

Refer to the Instructions for Use provided with each product for complete user information.