Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Bile Duct Neoplasm, Obstructive Jaundice
Both
Bile Duct Neoplasm, Obstructive Jaundice
Trial Information
Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Inclusion Criteria:
- age ≥ 18 years
- patient who have obstructive jaundice (bilirubin > 2.0mg/dl) due to hilar malignancy
Exclusion Criteria:
- patients with endoscopic retrograde cholangiogram is not possible
- bleeding tendency (PT INR > 1.5, platelet < 50,000)
- poor general condition (ECOG 3-4) or cardiopulmonary deterioration
- pregnancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
The time taken to insert bilateral stent
Outcome Time Frame:
After the ERCP procedure
Safety Issue:
Yes
Principal Investigator
Kwang hyuck Lee, MD, phD
Investigator Role:
Study Director
Investigator Affiliation:
Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Authority:
South Korea: Institutional Review Board
Study ID:
KH0LEE
NCT ID:
NCT01622803
Start Date:
August 2011
Completion Date:
August 2013
Related Keywords:
- Bile Duct Neoplasm
- Obstructive Jaundice
- Bile Duct Neoplasms
- Neoplasms
- Jaundice
- Jaundice, Obstructive
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