Endoscopy 2021; 53(06): 578-585
DOI: 10.1055/a-1256-0571
Original article

Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study

Woo Hyun Paik
1  Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
,
Sang Myung Woo
2  Center for Liver and Pancreatobiliary Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea
,
Jung Won Chun
1  Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
,
Byeong Jun Song
3  Department of Internal Medicine, Myongji Hospital, Goyang, Korea
,
Woo Jin Lee
2  Center for Liver and Pancreatobiliary Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Korea
,
Dong-Won Ahn
4  Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Republic of Korea
,
Yoon Suk Lee
5  Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Korea
,
Young Hoon Choi
6  Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
,
Ji Kon Ryu
1  Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
,
Yong-Tae Kim
1  Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
,
Sang Hyub Lee
1  Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
› Author Affiliations
Trial Registration: ClinicalTrials.gov Registration number (trial ID): NCT03439020 Type of study: prospective randomized multi-center study


Abstract

Background Two types of self-expandable metal stents (SEMS) are available for malignant distal biliary obstruction: fully covered SEMS (FCSEMS) and uncovered SEMS. FCSEMS can prevent stent ingrowth, but a major concern is spontaneous migration. This study aimed to determine whether the additional insertion of a double-pigtail plastic stent to anchor the FCSEMS can prevent migration.

Methods 68 patients with unresectable, malignant, distal, biliary obstruction were included in this multicenter, randomized, superiority trial. The patients were randomly assigned to receive either the FCSEMS plus an anchoring plastic stent (n = 33) or an FCSEMS alone (n = 35). After placement of the FCSEMS, the anchoring stent was inserted inside the FCSEMS. The primary outcome was the rate of stent migration during the 6-month follow-up. The secondary outcomes were stent-related adverse events, stent patency, and survival rates.

Results The baseline characteristics were similar between the two groups. The rate of stent migration at 6 months was significantly lower in patients with the FCSEMS plus anchoring stent (15 % vs. 40 %; P = 0.02). The mean stent patency was significantly longer in the FCSEMS plus anchoring group (237 days [95 % confidence interval [CI] 199 to 275] vs. 173 days [95 %CI 130 to 217]; P = 0.048). There were no significant differences in stent-related adverse events and overall survival rates at 6 months between the two groups.

Conclusions Our data suggest that the additional double-pigtail plastic stent anchored the FCSEMS to prevent migration and prolonged patency without any serious adverse events.



Publication History

Received: 02 June 2020

Accepted: 04 September 2020

Publication Date:
04 September 2020 (online)

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