Metallic stents in malignant biliary obstruction: prospective long-term clinical results.

OBJECTIVE: The purpose of this prospective study was to evaluate the long-term clinical efficacy of metallic stents when used as the initial palliative treatment of patients with inoperable malignant biliary obstruction.

SUBJECTS AND METHODS: From August 1991 through May 1995, 100 consecutive patients with malignant biliary obstruction were treated with percutaneous placement of metallic stents. The causes of obstruction were bile duct carcinoma (n = 50), pancreatic carcinoma (n = 17), gallbladder carcinoma (n = 6), hepatocellular carcinoma (n = 2), and metastatic lymphadenopathy in the hepatoduodenal ligament (n = 25). We used 123 stents: 64 Gianturco Z stents, 39 Hanaro spiral stents, 16 Wallstents, two tantalum Strecker stents, one Endocoil stent, and one Memotherm nitinol stent. Every 3 months we followed up all patients except those who died. The average length of follow-up was 220 days (range, 4-1125 days). Patient survival and stent patency rates were estimated by life-table analysis.

RESULTS: The median length of survival for the entire patient group was 246 days: 25-week and 50-week survival rates were 62% and 25%, respectively. We found no statistically significant difference in the median length of survival between patients with hilar obstruction (256 days) and patients with common bile duct (CBD) obstruction (227 days). Patients with bile duct carcinoma had longer median survival (269 days) than did patients with other conditions (197 days). The overall median length of patency for all stents was 360 days; the 25-week and 50-week patency rates were 81% and 53%, respectively. The stent patency rate at the median length of survival was 71%. The median length of stent patency in patients with hilar obstruction (617 days) was nearly double that of patients with CBD obstruction (324 days). However, the median length of stent patency in patients with bile duct carcinoma showed no statistically significant difference from the median length in patients with other disease. Four patients (4%) died within 1 month after stent placement. Twenty-one patients (21%) developed recurrent jaundice or cholangitis. In order of frequency, the causes of recurrent jaundice were tumor overgrowth, incrustation of bile sludge, duodenal obstruction due to tumor invasion, stent impaction into the bile duct wall, stent malposition, and tumor ingrowth.

CONCLUSION: Metallic stents showed a favorable patency rate with regard to patient survival. In patients with hilar obstruction, the clinical efficacy of metallic stents was superior to that in patients with CBD obstruction. We believe that placement of metallic stents is the procedure of choice for palliation of malignant biliary obstruction.