结合EUS和ERCP胆管癌患者与疑似

                               
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Patient with history of colon cancer presents with jandice and ampullary lesion. Goal of combined EUS and ERCP procedure to ease symptoms of jaundice and determine if patient is a candidate for an endoscopic resection. Evolution Biliary Uncovered stent placed to provide CBD drainage.

Prof. Marc Giovannini is a paid consultant for Cook Medical.

INTENDED USE: This device is used in palliation of malignant neoplasms in the biliary tree.

NOTES: Do not use this device for any other purpose than the stated intended use.

If the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. Please notify Cook for return authorization.

Use of this device is restricted to a trained healthcare professional. Store in a dry location, away from temperature extremes.Not compatible with THSF wire guide.

CONTRAINDICATIONS: Those specific to ERCP and any procedure to be performed in conjunction with stent placement.

Additional contraindications include, but are not limited to: inability to pass the wire guide or stent through the obstructed area, biliary duct strictures of benign etiology, biliary obstruction preventing endoscopic cholangiography, concurrent perforated bile duct, those patients for whom endoscopic procedures are contraindicated, patients with coagulopathy, concurrent bile duct stones, very small intrahepatic ducts and any use other than those specifically outlined under Intended Use.

POTENTIAL COMPLICATIONS: Potential complications associated with ERCP include, but are not limited to: pancreatitis, cholangitis, cholecystitis, cholestasis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.

Additional complications that can occur in conjunction with biliary stent placement include, but are not limited to: trauma to the biliary tract or duodenum; perforation; obstruction of the pancreatic duct; stent migration; stent occlusion; ingrowth due to tumor or excessive hyperplastic tissue; tumor overgrowth; stent misplacement, pain, fever, nausea, vomiting, inflammation, recurrent obstructive jaundice, bile duct ulceration, death (other than due to normal disease progression).

PRECAUTIONS: Refer to the package label for the minimum channel size required for this device.

A complete diagnostic evaluation should be performed prior to placement to measure the stricture length and determine the proper stent length. The stent length chosen should allow for additional length on either side of the stricture.

Note: In the event a single stent will not adequately cover the stricture, a second stent of the same diameter should be placed providing adequate overlapping (minimum 1cm) of the initially placed stent to ensure a bridging of the stricture between the stents. If wire guide or stent cannot advance through obstructed area, do not attempt to place stent.

Stent should be placed using fluoroscopic and endoscopic monitoring.

The stent should only be placed with the Cook delivery system, which is provided with each stent.

This stent is intended for palliative treatment only. Alternate methods of therapy should be investigated prior to placement.

After stent placement, additional methods of treatment such as chemotherapy and irradiation may increase the risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding.

Long-term patency with this stent has not been established. Periodic evaluation of the stent is advised. Assessment must be made to determine the necessity of sphincterotomy or balloon dilation prior to stent placement. In the event sphincterotomy or balloon dilation is required, all appropriate cautions, warnings and contraindications must be observed.