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Comparison Between Two Methods of Bilateral Stenting for Malignant Hilar Obstruction

Phase 3
Withdrawn
Conditions
Bile Duct Neoplasm
Obstructive Jaundice
Registration Number
NCT01622803
Lead Sponsor
Samsung Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The time taken to insert bilateral stentAfter the ERCP procedure
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center
🇰🇷Seoul, Korea, Republic of

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