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

Ki Tae Suk, Jae Woo Kim, Hyunsoo Kim, Soonkoo Baik, Seok Jin Oh, Se Joon Lee, Ho Gak Kim, Don Haeng Lee, Yong Hyun Won, DongKi Lee

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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.

Original languageEnglish
Pages (from-to)798-803
Number of pages6
JournalGastrointestinal Endoscopy
Volume66
Issue number4
DOIs
Publication statusPublished - 2007 Oct 1

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Paclitaxel
Multicenter Studies
Stents
Membranes
Cholecystitis
Cholangitis
Survival
Obstructive Jaundice
Biliary Tract
Sewage
Bile
Endoscopy
Drainage
Neoplasms
Safety

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Suk, Ki Tae ; Kim, Jae Woo ; Kim, Hyunsoo ; Baik, Soonkoo ; Oh, Seok Jin ; Lee, Se Joon ; Kim, Ho Gak ; Lee, Don Haeng ; Won, Yong Hyun ; Lee, DongKi. / Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction : multicenter pilot study. In: Gastrointestinal Endoscopy. 2007 ; Vol. 66, No. 4. pp. 798-803.
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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.",
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Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction : multicenter pilot study. / Suk, Ki Tae; Kim, Jae Woo; Kim, Hyunsoo; Baik, Soonkoo; Oh, Seok Jin; Lee, Se Joon; Kim, Ho Gak; Lee, Don Haeng; Won, Yong Hyun; Lee, DongKi.

In: Gastrointestinal Endoscopy, Vol. 66, No. 4, 01.10.2007, p. 798-803.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Human application of a metallic stent covered with a paclitaxel-incorporated membrane for malignant biliary obstruction

T2 - multicenter pilot study

AU - Suk, Ki Tae

AU - Kim, Jae Woo

AU - Kim, Hyunsoo

AU - Baik, Soonkoo

AU - Oh, Seok Jin

AU - Lee, Se Joon

AU - Kim, Ho Gak

AU - Lee, Don Haeng

AU - Won, Yong Hyun

AU - Lee, DongKi

PY - 2007/10/1

Y1 - 2007/10/1

N2 - 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.

AB - 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.

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