NCT01622803

Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bile Duct Neoplasm
• Obstructive Jaundice

Interventions

Type	Name	Description
PROCEDURE	parallel stent	bilateral parallel stent insertion (right and left side)
DEVICE	Y-stent (BONASTENT M-Hilar)	Bilateral Y-stent insertion (stent in stent type)

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-06-19
• Last updated: 2016-04-26

Locations

1 site across 1 country: South Korea