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Clinical Trials/NCT01622803
NCT01622803
Withdrawn
Phase 3

Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Samsung Medical Center1 site in 1 countryAugust 2011
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ConditionsBile Duct NeoplasmObstructive Jaundice

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Bile Duct Neoplasm
Sponsor
Samsung Medical Center
Locations
1
Primary Endpoint
The time taken to insert bilateral stent
Status
Withdrawn
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
August 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kwang Hyuck Lee

Assistant Professor of Medicine

Samsung Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

The time taken to insert bilateral stent

Time Frame: After the ERCP procedure

Study Sites (1)

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