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, Dong Ki Lee

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10 Citations (Scopus)


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
Issue number9
Publication statusPublished - 2019

Bibliographical note

Funding Information:
This work was supported by the following programs: the Technology Innovation Program (10044021, Development of non-vascular drug eluting stent for treatment of gastrointestinal disease), funded by the Ministry of Trade, Industry and Energy (MI, Korea). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors would like to thank Dong-Su Jang, MFA, (Medical Illustrator) for his help with the illustrations.

Publisher Copyright:
© Georg Thieme Verlag KG Stuttgart New York.

All Science Journal Classification (ASJC) codes

  • Gastroenterology


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