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

• Published in: Gastrointestinal endoscopy Vol. 66; no. 4; pp. 798 - 803
• Main Authors: Suk, Ki Tae, MD, Kim, Jae Woo, MD, PhD, Kim, Hyun Soo, MD, PhD, Baik, Soon Koo, MD, PhD, Oh, Seok Jin, MD, Lee, Se Joon, MD, PhD, Kim, Ho Gak, MD, PhD, Lee, Don Haeng, MD, PhD, Won, Yong Hyun, PhD, Lee, Dong Ki, MD, PhD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01-10-2007; Elsevier
• Subjects: Aged; Aged, 80 and over; Antineoplastic Agents, Phytogenic - pharmacology; Bile Duct Neoplasms - complications; Bile Duct Neoplasms - mortality; Bile Duct Neoplasms - surgery; Biological and medical sciences; Cholangiopancreatography, Endoscopic Retrograde - methods; Cholestasis - etiology; Cholestasis - mortality; Cholestasis - surgery; Coated Materials, Biocompatible; Digestive system. Abdomen; Endoscopy; Female; Follow-Up Studies; Gastroenterology and Hepatology; Humans; Incidence; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Metals; Middle Aged; Paclitaxel - pharmacology; Pilot Projects; Postoperative Complications - epidemiology; Prospective Studies; Prosthesis Design; Prosthesis Implantation - instrumentation; Stents; Survival Rate; Treatment Outcome; metallic stent covered with a paclitaxel membrane; MSCPM; Antineoplastic agent; Human; Biliary tract; Taxane derivatives; Paclitaxel; Instrumentation therapy; Malignant tumor; Antimitotic; Stent; Cancer
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2007.05.037

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.