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