Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction
|ClinicalTrials.gov Identifier: NCT01622803|
Recruitment Status : Withdrawn (Patients enrollment problem)
First Posted : June 19, 2012
Last Update Posted : April 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Bile Duct Neoplasm Obstructive Jaundice||Procedure: parallel stent Device: Y-stent (BONASTENT M-Hilar)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
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
- The time taken to insert bilateral stent [ Time Frame: After the ERCP procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|