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Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent


N/A
18 Years
N/A
Open (Enrolling)
Both
Obstruction of Biliary Tree, Cholangiocarcinoma, Hepatocellular Carcinoma, Malignant Lymphadenopathy, Gall Bladder Cancer

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Trial Information

Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent


Inclusion Criteria:



- Age> 18

- diagnosis of malignancy in pathology or cytology

- jaundice(Total bilirubin)> 2.0 mg/dL

- Diagnosed malignant hilar invasion to CT or other image finding

Exclusion Criteria:

- bleeding tendency(INR>1.5)

- Pregnancy

- severe liver,kidney disease

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:

Participants will followed for the new obstruction(new jaundice) will occur.

Outcome Time Frame:

up to 1year

Safety Issue:

Yes

Principal Investigator

Kwang hyuck Lee, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Division of Gastroenterology,Department of internal medicaion,samsung medical center,Sungkyunkwan University School of Medicine

Authority:

South Korea: Institutional Review Board

Study ID:

2013-03-014-002

NCT ID:

NCT01875549

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Obstruction of Biliary Tree
  • Cholangiocarcinoma
  • Hepatocellular Carcinoma
  • Malignant Lymphadenopathy
  • Gall Bladder Cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Lymphatic Diseases
  • Carcinoma, Hepatocellular

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