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.
To compare the successful drainage rates of endoscopic SEMSs and PSs.
A single-center, open-label randomized controlled trial.
University hospital in KhonKaen, Thailand.
One hundred eight patients with unresectable complex, Bismuth type II-IV HCA.
Endoscopic retrograde cholangiography with unilateral SEMS or PS insertion.
Main Outcome Measurements
Successful drainage rate.
Diagnosis of HCA was made by clinical presentations, imaging studies, and clinical outcome during follow-up.
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).
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)
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- Causes of cholestasis in Thailand: a study of 276 consecutive patients.Am J Surg. 1984; 147: 360-366
- Trends in the incidence of primary liver and biliary tract cancers in England and Wales 1971-2001.Br J Cancer. 2006; 94: 1751-1758
- A comparison of trends in the incidence of hepatocellular carcinoma and intrahepatic cholangiocarcinoma in the United States.Cancer Epidemiol Biomarkers Prev. 2006; 15: 1198-1203
- Surgery for hilar cholangiocarcinoma: French experience in a collective survey of 552 extrahepatic bile duct cancers.J Hepatobiliary Pancreat Surg. 2000; 7: 128-134
- Optimal biliary drainage for inoperable Klatskin's tumor based on bismuth type.World J Gastroenterol. 2007; 13: 3948-3955
- Palliative treatment with self-expandable metallic stents in patients with advanced type III or IV hilar cholangiocarcinoma: a percutaneous versus endoscopic approach.Gastrointest Endosc. 2009; 69: 55-62
- Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life.Gastrointest Endosc. 2002; 56: 835-841
- Magnetic resonance cholangiopancreatography-guided unilateral endoscopic stent placement for Klatskin tumors.Gastrointest Endosc. 2001; 53: 40-46
- Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study.Gastrointest Endosc. 2003; 58: 50-53
- Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents.Gastrointest Endosc. 2003; 58: 41-49
- Optimum palliation of inoperable hilar cholangiocarcinoma: comparative assessment of the efficacy of plastic and self-expanding metal stents.Dig Dis Sci. 2011; 56: 1557-1564
- Result of endoscopic biliary drainage in hilar cholangiocarcinoma.J Clin Gastroenterol. 2004; 38: 518-523
- Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents.Gastrointest Endosc. 2002; 56: 33-39
- Plastic versus self-expanding metallic stents for malignant hilar biliary obstruction: a prospective multicenter observational cohort study.J Clin Gastroenterol. 2008; 42: 1040-1046
- Relief of malignant obstructive jaundice by endoscopic or percutaneous insertion of metal stents.Bildgebung. 1993; 60: 76-82
- Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma.Ann Surg. 2001; 234 (discussion 517-9): 507-517
- Endoscopic sphincterotomy complications and their management: an attempt at consensus.Gastrointest Endosc. 1991; 37: 383-393
- Complications of endoscopic biliary sphincterotomy.N Engl J Med. 1996; 335: 909-918
- Malignant hilar strictures: one stent or two?.Gastrointest Endosc. 2010; 72: 736-738
- Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized, and controlled study.Gastrointest Endosc. 2001; 53: 547-553
- Endoscopic retrograde cholangiopancreatography and endoscopic endoprosthesis insertion in patients with Klatskin tumors.Arch Surg. 1998; 133: 293-296
- Prediction of drainage effectiveness during endoscopic stenting of malignant hilar strictures: the role of liver volume assessment.Gastrointest Endosc. 2010; 72: 728-735
- A survival analysis of patients with malignant biliary strictures treated by percutaneous metallic stenting.Cardiovasc Intervent Radiol. 2007; 30: 66-73
- Predictive factors for survival in patients with inoperable Klatskin tumors.Hepatogastroenterology. 2006; 53: 21-27
- Endoscopic biliary therapy using the combined percutaneous and endoscopic technique.Gastroenterology. 1989; 96: 1180-1186
- Cholangiocarcinoma: lessons from Thailand.Curr Opin Gastroenterol. 2008; 24: 349-356
Published online: May 17, 2012
Accepted: February 22, 2012
Received: November 15, 2011
DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
See CME section; p. 159.
© 2012 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
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- 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.