Diamond stents for palliation of malignant bile duct obstruction: A prospective multicenter evaluation

Background and Study Aims: Various types of self-expandable metal stents ha ve been introduced for biliary drainage in patients with malignant jaundice , showing prolonged patency compared with plastic endoprostheses. However, there has only been prolonged experience with a meaningful number of patien ts using the Wall-stent. We evaluated the Diamond stent, a self-expanding u ncoated biliary metal stent, in a prospective uncontrolled multicenter sett ing. Patients and Methods: The eligibility criterion was obstructive jaundice du e to inoperable malignant disease. Between August 1995 and January 2000, 12 6 patients, who received a total of 134 Diamond stents in four European cen ters, were followed prospectively. Results: Technical and clinical success rates were 96% and 98%, respectivel y. No major procedure-related complications occurred. The 30-day mortality rate was 13 %. Stent occlusion occurred in 28 patients (22 %). Overall medi an stent patency was 477 days; overall median survival was 173 days. Stent occlusion, confirmed by endoscopic retrograde cholangiopancreatography, was successfully treated with plastic stents in all patients. Cost analysis re vealed estimated costs of Euro3440 per patient for palliative treatment wit h the Diamond stent. Conclusions: The Diamond stent compares favorably with other biliary metal stents for patients requiring biliary drainage of malignant jaundice.