Background and Aims
The optimal type of stent for the palliation of malignant biliary obstruction in patients
with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative
intent is unknown. We performed a prospective trial comparing 3 types of biliary stents—fully
covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and
plastic—to determine which best optimized cost-effectiveness and important clinical
outcomes.
Methods
In this prospective randomized trial, consecutive patients with malignant biliary
obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant
chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during
the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical
resection, or death after the initiation of neoadjuvant therapy, and the secondary
outcomes were total patient costs associated with the stent, including the index ERCP
cost, downstream hospitalization cost due to stent occlusion, and the cost associated
with procedural adverse event.
Results
Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS
group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic
or tumor characteristic differences were noted among the groups. The fcSEMSs had a
longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74
and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical
resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS =
$24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and
fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per
patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01).
Conclusions
In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant
biliary obstruction in patients undergoing neoadjuvant therapy with curative intent
for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness,
although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer
time to stent occlusion. (Clincial trial registration number: NCT01038713.)
Abbreviations:
AE (adverse event), fcSEMS (fully covered self-expandable metal stent), IV (intravenously), PEP (post-ERCP pancreatitis), SEMS (self-expandable metal stent), uSEMS (uncovered self-expandable 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: March 10, 2016
Accepted:
February 26,
2016
Received:
October 8,
2015
Footnotes
DISCLOSURE: Dr Gardner is supported in part by NIH grant 1K23DK088832. All authors disclosed no financial relationships relevant to this publication.
If you would like to chat with an author of this article, you may contact Dr Gardner at [email protected]
Identification
Copyright
Copyright © 2016 by the American Society for Gastrointestinal Endoscopy
