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


METHODS
A case series that includes 4 endoscopy centers.


METHODS
From July 2003 to August 2006, a total of 21 patients diagnosed with unresectable malignant biliary obstruction.


METHODS
Endoscopic placement of an MSCPM.


METHODS
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.


CONCLUSIONS
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.
Suk
Ki Tae
KT
Division of Gastroenterology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea.
Kim
Jae Woo
JW
Kim
Hyun Soo
HS
Baik
Soon Koo
SK
Oh
Seok Jin
SJ
Lee
Se Joon
SJ
Kim
Ho Gak
HG
Lee
Don Haeng
DH
Won
Yong Hyun
YH
Lee
Dong Ki
DK
D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology; D001650:Bile Duct Neoplasms / Q000150:complications / Q000401:mortality / Q000601:surgery*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D002779:Cholestasis / Q000209:etiology / Q000401:mortality / Q000601:surgery*; D020099:Coated Materials, Biocompatible; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008670:Metals; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000295:instrumentation*; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D020099:Coated Materials, Biocompatible; D008670:Metals; D017239:Paclitaxel