Endoscopy 2019; 51(09): 843-851
DOI: 10.1055/a-0754-5763
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Sung Ill Jang
1  Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
,
Kyu Taek Lee
2  Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
,
Jung Sik Choi
3  Department of Internal Medicine, Busan Paik Hospital Inje University College of Medicine, Pusan, South Korea
,
Seok Jeong
4  Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea
,
Don Haeng Lee
4  Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea
5  Utah-Inha DDS and Advanced Therapeutics Research Center, Incheon, South Korea
,
Yong Tae Kim
6  Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea
,
Sang Hyub Lee
6  Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea
,
Jeong-Sik Yu
7  Department of Radiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
,
Dong Ki Lee
1  Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
› Author Affiliations
TRIAL REGISTRATION: Multi-Center, Randomized, prospective trial NCT02460432 at clinicaltrials.gov
Further Information

Publication History

submitted 17 May 2018

accepted after revision 20 August 2018

Publication Date:
09 November 2018 (online)

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.

Fig. e5, Table e4 – e5