Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: A prospective randomized comparative study

Sung Ill Jang, Kyu Taek Lee, Jung Sik Choi, Seok Jeong, Don Haeng Lee, Yong Tae Kim, Sang Hyub Lee, Jeong Sik Yu, DongKi Lee

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Backgrounds The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III) were compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. Methods Patients with unresectable distal malignant biliary obstructions (n=106) were prospectively enrolled in this study at multiple treatment centers. Stents were placed endoscopically: MSCPM-III in 54 patients and CMS in 51 patients. The patients received systemic chemotherapy regimens according to their disease characteristics. Results The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS.Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups (P =0.84 and P =0.29, respectively). However, tumor size at 2 months after stent insertion was significantly decreased in patients in the MSCPM-III group with bile duct cancers or those who experienced stent migration compared with the CMS group.Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. Conclusions Although compared with a CMS the MSCPM-III did not significantly influence time to RBO or survival duration in patients with malignant biliary obstructions, MSCPM-III reduced tumor volume and was used safely in humans.

Original languageEnglish
Pages (from-to)843-851
Number of pages9
JournalEndoscopy
Volume51
Issue number9
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Paclitaxel
Stents
Metals
decanoic acid
Bile Duct Neoplasms
Cholangitis
Survival
Tumor Burden
Pancreatitis
Neoplasms
Safety
Drug Therapy

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

Jang, Sung Ill ; Lee, Kyu Taek ; Choi, Jung Sik ; Jeong, Seok ; Lee, Don Haeng ; Kim, Yong Tae ; Lee, Sang Hyub ; Yu, Jeong Sik ; Lee, DongKi. / Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction : A prospective randomized comparative study. In: Endoscopy. 2019 ; Vol. 51, No. 9. pp. 843-851.
@article{a7ac746bf656456fa34601330154dbed,
title = "Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: A prospective randomized comparative study",
abstract = "Backgrounds The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III) were compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. Methods Patients with unresectable distal malignant biliary obstructions (n=106) were prospectively enrolled in this study at multiple treatment centers. Stents were placed endoscopically: MSCPM-III in 54 patients and CMS in 51 patients. The patients received systemic chemotherapy regimens according to their disease characteristics. Results The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS.Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups (P =0.84 and P =0.29, respectively). However, tumor size at 2 months after stent insertion was significantly decreased in patients in the MSCPM-III group with bile duct cancers or those who experienced stent migration compared with the CMS group.Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. Conclusions Although compared with a CMS the MSCPM-III did not significantly influence time to RBO or survival duration in patients with malignant biliary obstructions, MSCPM-III reduced tumor volume and was used safely in humans.",
author = "Jang, {Sung Ill} and Lee, {Kyu Taek} and Choi, {Jung Sik} and Seok Jeong and Lee, {Don Haeng} and Kim, {Yong Tae} and Lee, {Sang Hyub} and Yu, {Jeong Sik} and DongKi Lee",
year = "2019",
month = "1",
day = "1",
doi = "10.1055/a-0754-5763",
language = "English",
volume = "51",
pages = "843--851",
journal = "Endoscopy",
issn = "0013-726X",
publisher = "Georg Thieme Verlag",
number = "9",

}

Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction : A prospective randomized comparative study. / Jang, Sung Ill; Lee, Kyu Taek; Choi, Jung Sik; Jeong, Seok; Lee, Don Haeng; Kim, Yong Tae; Lee, Sang Hyub; Yu, Jeong Sik; Lee, DongKi.

In: Endoscopy, Vol. 51, No. 9, 01.01.2019, p. 843-851.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction

T2 - A prospective randomized comparative study

AU - Jang, Sung Ill

AU - Lee, Kyu Taek

AU - Choi, Jung Sik

AU - Jeong, Seok

AU - Lee, Don Haeng

AU - Kim, Yong Tae

AU - Lee, Sang Hyub

AU - Yu, Jeong Sik

AU - Lee, DongKi

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Backgrounds The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III) were compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. Methods Patients with unresectable distal malignant biliary obstructions (n=106) were prospectively enrolled in this study at multiple treatment centers. Stents were placed endoscopically: MSCPM-III in 54 patients and CMS in 51 patients. The patients received systemic chemotherapy regimens according to their disease characteristics. Results The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS.Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups (P =0.84 and P =0.29, respectively). However, tumor size at 2 months after stent insertion was significantly decreased in patients in the MSCPM-III group with bile duct cancers or those who experienced stent migration compared with the CMS group.Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. Conclusions Although compared with a CMS the MSCPM-III did not significantly influence time to RBO or survival duration in patients with malignant biliary obstructions, MSCPM-III reduced tumor volume and was used safely in humans.

AB - Backgrounds The placement of a self-expandable metal stent (SEMS) is widely used in patients with unresectable malignant biliary obstructions, but SEMSs are susceptible to occlusion by tumor ingrowth or overgrowth. The efficacy and safety of a novel paclitaxel-eluting biliary metal stent incorporating sodium caprate (MSCPM-III) were compared prospectively with those of a covered metal stent (CMS) in patients with malignant biliary obstructions. Methods Patients with unresectable distal malignant biliary obstructions (n=106) were prospectively enrolled in this study at multiple treatment centers. Stents were placed endoscopically: MSCPM-III in 54 patients and CMS in 51 patients. The patients received systemic chemotherapy regimens according to their disease characteristics. Results The two groups did not differ significantly in basic characteristics or mean follow-up period. Stent occlusion occurred in 14 patients who received MSCPM-III and in 11 patients who received CMS.Time to recurrent biliary obstruction (RBO) and survival time did not differ significantly between the two groups (P =0.84 and P =0.29, respectively). However, tumor size at 2 months after stent insertion was significantly decreased in patients in the MSCPM-III group with bile duct cancers or those who experienced stent migration compared with the CMS group.Complications, including cholangitis and pancreatitis, were found to be acceptable in both groups. Conclusions Although compared with a CMS the MSCPM-III did not significantly influence time to RBO or survival duration in patients with malignant biliary obstructions, MSCPM-III reduced tumor volume and was used safely in humans.

UR - http://www.scopus.com/inward/record.url?scp=85069927067&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85069927067&partnerID=8YFLogxK

U2 - 10.1055/a-0754-5763

DO - 10.1055/a-0754-5763

M3 - Article

C2 - 30414164

AN - SCOPUS:85069927067

VL - 51

SP - 843

EP - 851

JO - Endoscopy

JF - Endoscopy

SN - 0013-726X

IS - 9

ER -