Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
Internal biliary drainage using stent is used for malignant hilar obstruction such as cholangiocarcinoma, hepatocellular carcinoma and other malignancy including metastasis.
Bilateral drainage is more physiologic and have more long patency than unilateral drainage.
There are two methods of bilateral drainage: Y-stent and side by side.
However there are no clinical data about comparing the effectiveness of these two methods.
Therefore the investigators want to compare the clinical outcomes of two methods:
Y-stent and side by side.
|Bile Duct Neoplasm Obstructive Jaundice||Procedure: parallel stent Device: Y-stent (BONASTENT M-Hilar)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction|
- The time taken to insert bilateral stent [ Time Frame: After the ERCP procedure ]
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: parallel stent
parallel stent insertion group
Procedure: parallel stent
bilateral parallel stent insertion (right and left side)
Other Name: bilateral pig tail plastic stent
Active Comparator: Y-stent
Y-stent insertion group
Device: Y-stent (BONASTENT M-Hilar)
Bilateral Y-stent insertion (stent in stent type)
Other Name: BONASTENT M-Hilar, Standard Sci Tech Inc, Seoul, South Korea
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622803
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Study Director:||Kwang hyuck Lee, MD, phD||Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine|