Background
Endoscopic biliary stent drainage is effective in the palliative treatment of patients
with hilar cholangiocarcinoma (HCA). However, no randomized controlled trial comparing
the efficacy of the self-expandable metal stent (SEMS) and the plastic stent (PS)
in patients with unresectable complex HCA is available.
Objective
To compare the successful drainage rates of endoscopic SEMSs and PSs.
Design
A single-center, open-label randomized controlled trial.
Setting
University hospital in KhonKaen, Thailand.
Patients
One hundred eight patients with unresectable complex, Bismuth type II-IV HCA.
Interventions
Endoscopic retrograde cholangiography with unilateral SEMS or PS insertion.
Main Outcome Measurements
Successful drainage rate.
Limitations
Diagnosis of HCA was made by clinical presentations, imaging studies, and clinical
outcome during follow-up.
Results
One hundred eight patients were randomly allocated to the SEMS and PS groups. Intention-to-treat
analysis revealed that the successful drainage rate in the SEMS group was higher than
in the PS group (70.4% vs 46.3%, P = .011). The median survival times were 126 and 49 days, respectively, in the SEMS
and PS groups. The overall survival rates of the patients in both groups were statistically
different by log-rank test (P = .002).
Conclusions
Endoscopic biliary drainage with the SEMS provides better adequacy of drainage and
longer survival compared with the PS in patients with unresectable complex HCA. (Clinical
trial registration number: NCT00721175.)
Abbreviations:
EBD (endoscopic biliary drainage), HCA (hilar cholangiocarcinoma), ITT (intention-to-treat), PS (plastic stent), PTBD (percutaneous transhepatic biliary drainage), SEMS (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: May 17, 2012
Accepted:
February 22,
2012
Received:
November 15,
2011
Footnotes
DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
See CME section; p. 159.
Identification
Copyright
© 2012 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Is a self-expandable metal stent better than a plastic stent in unresectable complex hilar cholangiocarcinoma with regard to the adequacy of drainage and survival of the patients?Gastrointestinal EndoscopyVol. 77Issue 1
- PreviewWe read with great interest the recent article by Sangchan et al.1 The authors concluded that endoscopic biliary drainage with a self-expandable metal stent (SEMS) provides better adequacy of drainage and longer survival compared with the plastic stent (PS) in patients with unresectable complex hilar cholangiocarcinoma. It is an interesting study. Nevertheless, several issues seem worthy of comment.
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