⁎4651 Palliation of malignant bile duct obstruction with the diamond stent®: a prospective, multicenter evaluation.

Self expanding metal endoprostheses for biliary drainage have been designed to increase stent patency compared to plastic endoprostheses. The new Diamond® Stent (Boston Scientific Corp., USA), an uncovered self expanding metal endoprosthesis made from nitinol, is supposed to increase stent patency further more due to an improved stent design. The ESGE Research Comittee therefore initiated this prospective, mulitcenter study. Since April 1997 111 patients (53 males and 58 females; mean age 72 years, range 34 - 88ys.) were treated with 119 stents. The reasons for bile - duct obstruction were pancreatic cancer in 62 patients, bile duct cancer in 23 patient, hilar lymph nodes in 12 patients, cancer of the gallbladder in 8 patients and others in 6 patients. The site of obstruction was the distal third in 56%, the middle third in 31% and the proximal third of the main bile duct in 13%. Insertion was successful in 109 patients (98%). In 2 patients early reintervention was necessary due to insufficient stent expansion. During initial ERCP 3 stents had to be removed immediately, 2 of those did not open correctly, 1 was placed too far in the duodenum. No clinical complications due to the implantation procedure were observed. The mean follow up period is now 195 days (2 - 897). 84 patients (76%) died up to now. 30 day mortality is 15% (17 of 108). In 24 patients (22%) an occlusion of the Diamond®-Stent was observed after a mean period of 205 days. Median stent patency is 355 days and median survival is 174 days. After metal stent occlusion all patients were successfully treated with plastic endoprostheses. Stent occlusion occurred due to tumor-ingrowth or -overgrowth in 86% and due to sludge in 14%. Stent patency did not differ in patients with proximal or distal stenoses. Median patency in patients with distant metastases (n=54) was 201 days with a median survival of 93 days, whereas in patients without distant metastases (n=57) median patency was 367 days and median survival was 230 days. Cost analysis and evaluation of life quality (SF 36) are still pending. These results for biliary drainage of malignant jaundice with the Diamond®-Stent in a multicenter prospective setting compare favourably with other biliary metal stents. Metastases had a negative impact on stent patency whereas the site of the stenoses did not influence the performance of the stents.