Background and Aims
In a recent randomized controlled trial, a double bare metal stent (DBS) showed better
stent patency than single-layer metal stents. However, clear evidence comparing the
efficacy of uncovered (UCDBS) and partially covered (PCDBS) DBSs for distal malignant
biliary obstruction (MBO) is lacking. Therefore, we compared the clinical outcomes
including stent patency of UCDBSs versus PCDBSs.
Methods
A multicenter, randomized study was performed in patients with distal MBO. The primary
endpoint was stent patency. Secondary endpoints were the proportion of patients with
patent stents at 6 months, risk factors for stent dysfunction, overall survival, technical
and clinical success rates of stent placement, and other adverse events (AEs).
Results
Among 258 included patients, 130 were randomly assigned to the PCDBS group and 128
to the UCDBS group. The mean duration of stent patency of the PCDBS (421.2 days; 95%
confidence interval [CI], 346.7-495.7) was longer than that of the UCDBS (377.4 days;
95% CI, 299.7-455.0), although total stent dysfunction and stent dysfunction within
6 months were not different between groups. Multivariate analysis indicated that chemotherapy
after stent placement was a significant factor for overall survival (hazard ratio,
.570; 95% CI, .408-.796) and had a marginal impact on stent patency (hazard ratio,
1.569; 95% CI, .923-2.667). There were no remarkable differences in AEs, including
pancreatitis, cholecystitis, and stent migration, between the 2 groups.
Conclusions
The use of PCDBSs compared with UCDBSs in patients with distal MBO has unclear benefits
regarding stent patency and overall survival, although PCDBSs have a lower rate of
tumor ingrowth. (Clinical trial registration number: NCT 02937246.)
Graphical abstract
Graphical Abstract
Abbreviations:
AE (adverse event), CI (confidence interval), DBS (double bare metal stent), HR (hazard ratio), MBO (malignant biliary obstruction), PCDBS (partially covered double bare metal stent), SEMS (self-expandable metal stent), UCDBS (uncovered double bare metal stent)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: September 06, 2022
Accepted:
August 30,
2022
Received:
January 28,
2022
Footnotes
DISCLOSURE: All authors disclosed no financial relationships. Research support for this study was provided by the Korea Medical Device Development Fund grant funded by the Korea government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, the Ministry of Food and Drug Safety; Project No. KMDF_PR_20200901_0149) and the “SnG BIOTECH” Faculty Research Assistance Program of Yonsei University College of Medicine (4-2015-1147).
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