1. Fanelli Laparoscopic Endobiliary Stent Suggested Instructions for Use
Robert D. Fanelli, MD, FACS
Assistant Professor of Surgery University of Massachusetts Medical School Director of Surgical Endoscopy Berkshire Medical Center

2. Wire Guide Placement
After performing fluorocholangiography, place wire guide through the central port of the cholangiogram catheter. Advance wire guide through common bile duct, across ampulla, and allow to coil gently in the duodenum.

3. Catheter Removal
The cholangiogram catheter is then removed over the wire guide, maintaining good wire position across the ampulla. Visual confirmation is achieved by maintaining the entire blue colored portion of the wire guide within the cystic duct.

4. Dilate Cystic Duct
The outer diameter of the stent system is 8.5 French. Cystic duct dilation with a biliary dilation balloon is recommended if there is any concern that the cystic duct is too small to accommodate stent placement. About 30% of ducts required dilation in clinical studies.

5. Stent Introduction
Using fluoroscopic guidance, the stent system is introduced over the wire guide, through the common bile duct, and across the ampulla. The Tuohy-Borst valve is tightened during contrast injection to minimize leakage.

6. Positioning
After directing the stent across the ampulla over the wire guide, the stent is positioned so that markers 1 and 2 reside within the duodenum and markers 3 and 4 are within the common bile duct. Fluoroscopic imaging is essential to confirm proper positioning.

7. Retracting Safety Sheath
Remove the wire guide slowly, and recoil within the raceway in which it was shipped. Slowly retract the outer sheath, which securely attaches the stent to the delivery mechanism, back toward the purple and white Luer hubs, until it contacts the white hub.
Warning: Once the outer sheath has been retracted, it may not be possible to retrieve the stent using the delivery mechanism.

8. Stent Deployment
Unscrew purple Luer connector from white Luer connector. Deploy stent by pulling white Luer and inner cannula completely out while holding the outer assembly still. Visualize deployment under fluoroscopy by watching radiopaque markers 1, 2, and 3 pull through the larger fourth marker.

9. Assembly Removal
Remove delivery assembly and proceed with laparoscopic cholecystectomy. Prior to assembly removal, a completion cholangiogram can be performed by injecting contrast through the assembly, if desired.

10. Laparoscopic Endobiliary Stent
Final placement