Gut Liver.
2016 Nov;10(6):969-974. 10.5009/gnl15112.
A Double-Layered Covered Biliary Metal Stent for the Management of Unresectable Malignant Biliary Obstruction: A Multicenter Feasibility Study
- Affiliations
-
- 1Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
- 2The National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea.
- 3Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea.
- 4Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University School of Medicine, Bucheon, Korea.
- 5Division of Gastroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
- 6Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea. gidrdong@hanmail.net
- KMID: 2412104
- DOI: http://doi.org/10.5009/gnl15112
Abstract
- BACKGROUND/AIMS
The covered self-expandable metal stent (CMS) was developed to prevent tumor ingrowth-induced stent occlusion during the treatment of malignant biliary obstruction. However, complications such as cholecystitis, pancreatitis, and stent migration can occur after the endoscopic insertion of CMSs. The aim of the present study was to assess the efficacy and safety of a double-layered CMS (DCMS) for the management of malignant bile duct obstruction.
METHODS
DCMSs were endoscopically introduced into 59 patients with unresectable malignant extrahepatic biliary obstruction at four tertiary referral centers, and the patient medical records were retrospectively reviewed.
RESULTS
Both the technical and functional success rates were 100%. Procedure-related complications including pancreatitis, cholangitis, stent migration, and liver abscess occurred in five patients (8.5%). The median follow-up period was 265 days (range, 31 to 752 days). Cumulative stent patency rates were 68.2% and 40.8% at 6 and 12 months, respectively. At the final follow-up, the rate of stent occlusion was 33.9% (20/59), and the median stent patency period was 276 days (range, 2 to 706 days).
CONCLUSIONS
The clinical outcomes of DCMSs were comparable to the outcomes previously reported for CMSs with respect to stent patency period and complication rates.
Keyword
MeSH Terms
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Adult
Aged
Aged, 80 and over
Bile Duct Neoplasms/complications/surgery
Biliary Tract Surgical Procedures/*instrumentation/methods
Cholangitis/epidemiology/etiology
Cholestasis/etiology/*surgery
*Equipment Design
Feasibility Studies
Female
Follow-Up Studies
Foreign-Body Migration/epidemiology/etiology
Humans
Male
Metals
Middle Aged
Pancreatitis/epidemiology/etiology
Postoperative Complications/*epidemiology/etiology
Retrospective Studies
Stents/*adverse effects
Treatment Outcome
Metals
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