Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction: multicenter pilot study

Abstract

BACKGROUND: Paclitaxel, with its antitumor effect, may improve the function of metallic stents used for biliary drainage. However, clinical studies that use metallic stents covered with a paclitaxel-incorporated membrane (MSCPM) in the biliary tract of human beings have not been previously carried out. OBJECTIVE: To evaluate the safety and efficacy of an MSCPM for patients with malignant biliary obstruction. DESIGN AND SETTING: A case series that includes 4 endoscopy centers. PATIENTS: From July 2003 to August 2006, a total of 21 patients diagnosed with unresectable malignant biliary obstruction. INTERVENTION: Endoscopic placement of an MSCPM. MAIN OUTCOME MEASUREMENTS: Stent occlusion, complications, stent patency, patient survival, and the periodic mean concentration of paclitaxel in the blood. RESULTS: Occlusion of the MSCPM was observed in 9 patients and was caused by bile sludge or clog in 4, tumor overgrowth in 3, and tumor ingrowth in 2. Complications included obstructive jaundice in 6, cholangitis in 3, and 1 patient showed stent migration with cholecystitis. The mean patency of a MSCPM was 429 days (median 270 days, range 68-810 days) and cumulative patency rates at 3, 6, and 12 months were 100%, 71%, and 36%, respectively. The mean survival of patients was 350 days (median 281 days, range 68-811 days). The highest concentration of paclitaxel in the blood was found between 1 and 10 days after insertion. LIMITATIONS: Small number of patients and low rate of pathologic diagnosis. CONCLUSIONS: The endoscopic insertion of MSCPM is technically feasible, safe, and effective in patients with malignant biliary obstruction. In addition, MSCPM may exert local antitumor activity because of the steady release of paclitaxel.