The first prospective endoscopic experience with the ePTFE-covered Viabil stent in patients with a distal malignant biliary stenosis.

BACKGROUND AND STUDY AIMS

Endoscopic insertion of a biliary stent is standard practice in the palliative treatment of malignant biliary obstructions. Experience with the new ePTFE-covered Viabil stent is mainly limited to the percutaneous approach. We report our experience with its endoscopic application in patients with distal malignant biliary obstructions.

PATIENTS AND METHODS

Eleven patients with an inoperable tumour, without apparent metastatic disease, and with an ECOG score of 0 to 1, were included. All patients received an ePTFE-covered Viabil stent of 10 mm diameter, with transmural side-holes. Primary endpoints were stent patency and patient survival.

RESULTS

Overall median patient survival was 220 days; 10 patients died free of jaundice from non-stent related causes. Due to malfunction of the prototype stents at insertion, the introduction of 2 Viabils was required in 3 patients to acquire complete bile duct drainage. Thus, a total of 14 stents was needed in 11 patients. Stent dysfunction occurred in 3/11 patients. It always resulted from massive stone impaction needing stone removal with additional stenting in two out of 3 patients. Stent patency was 80% at 3 and 6 months, and 63% at 9 and 12 months. Lifetime palliation was 73%.

CONCLUSIONS

Although the biliary Viabil device has been developed to minimize bacterial adherence and sludge formation, stent dysfunctions in this series always resulted from stone impaction. Moreover, malfunction of the prototype stents needed the insertion of a second stent in 3 patients. Overall life time palliation was 73%. Further experience with newer versions of the device as well as comparative studies versus other metallic stents are needed.