Uncovered Self-expandable Metal Stent Versus Double Layer Plastic Stent for Malignant Hilar Stricture
NCT ID: NCT01125865
Last Updated: 2011-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2010-05-31
2011-12-31
Brief Summary
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There are few comparative study as to whether self-expanding metallic or plastic stent, especially DLS (double layer plastic stent) are preferable in the technical success, stent patency, and cost-effectiveness for palliating malignant hilar obstruction.
The study was designed to compare the the technical success, stent patency, and cost-effectiveness of self-expandable metal stent and DLS in patients with malignant hilar obstruction.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SEMS
Self-expandable metallic stent will be inserted for the malignant hilar obstruction.
SEMS insertion
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
DLS
DoubleLayer plastic stent (Olympus) will be inserted for malignant hilar obstruction.
DLS insertion
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
Interventions
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SEMS insertion
Self-expandable metallic stent will be inserted for malignant hilar obstruction.
DLS insertion
DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with malignant hilar obstruction
Exclusion Criteria
* Patient with uncorrectable severe coagulopathy
* Indication for surgical operation
* Karnofsky score \< 60%
18 Years
ALL
No
Sponsors
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Soon Chun Hyang University
OTHER
Responsible Party
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Soon Chun Hyang University Cheonan Hospital
Locations
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Soon Chun Hyang University Cheonan Hospital
Cheonan, 23-20 Bongmyung-dong, South Korea
Inje University Pusan Paik Hospital
Pusan, Busanjin-gu, Gaegeum-dong, South Korea
Asan Medical Center
Seoul, Pungnap-2dong, Songpagu, South Korea
Eulji University Hospital
Daejeon, Seo-gu, Dunsan-dong, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Tringali A, Mutignani M, Perri V, Zuccala G, Cipolletta L, Bianco MA, Rotondano G, Philipper M, Schumacher B, Neuhaus H, Schmit A, Deviere J, Costamagna G. A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures. Endoscopy. 2003 Dec;35(12):992-7. doi: 10.1055/s-2003-44601.
Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8. doi: 10.1055/s-2007-1010295.
de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999 Oct 28;341(18):1368-78. doi: 10.1056/NEJM199910283411807. No abstract available.
Yeoh KG, Zimmerman MJ, Cunningham JT, Cotton PB. Comparative costs of metal versus plastic biliary stent strategies for malignant obstructive jaundice by decision analysis. Gastrointest Endosc. 1999 Apr;49(4 Pt 1):466-71. doi: 10.1016/s0016-5107(99)70044-1.
Chang WH, Kortan P, Haber GB. Outcome in patients with bifurcation tumors who undergo unilateral versus bilateral hepatic duct drainage. Gastrointest Endosc. 1998 May;47(5):354-62. doi: 10.1016/s0016-5107(98)70218-4.
Davids PH, Groen AK, Rauws EA, Tytgat GN, Huibregtse K. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet. 1992 Dec 19-26;340(8834-8835):1488-92. doi: 10.1016/0140-6736(92)92752-2.
Prat F, Chapat O, Ducot B, Ponchon T, Pelletier G, Fritsch J, Choury AD, Buffet C. A randomized trial of endoscopic drainage methods for inoperable malignant strictures of the common bile duct. Gastrointest Endosc. 1998 Jan;47(1):1-7. doi: 10.1016/s0016-5107(98)70291-3.
Cheng JL, Bruno MJ, Bergman JJ, Rauws EA, Tytgat GN, Huibregtse K. Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents. Gastrointest Endosc. 2002 Jul;56(1):33-9. doi: 10.1067/mge.2002.125364.
Other Identifiers
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SCH-2010-04
Identifier Type: -
Identifier Source: org_study_id
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