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Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Bile Duct Obstruction, Klatskin's Tumor

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Trial Information

Uncovered Self-expandable Metal Stent Versus DoubleLayer Plastic Stent for Malignant Hilar Stricture: a Prospective Randomized Multicenter Trial


Inclusion Criteria:



- Patient over 18 years old

- Patient with malignant hilar obstruction

Exclusion Criteria:

- No written informed consent

- Patient with uncorrectable severe coagulopathy

- Indication for surgical operation

- Karnofsky score < 60%

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stent patency

Outcome Description:

Interval time (d) from stent insertion to occlusion

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Authority:

Korea: Institutional Review Board

Study ID:

SCH-2010-04

NCT ID:

NCT01125865

Start Date:

May 2010

Completion Date:

December 2011

Related Keywords:

  • Bile Duct Obstruction
  • Klatskin's Tumor
  • Malignant hilar stricture
  • Cholestasis
  • Klatskin's Tumor
  • Constriction, Pathologic

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