Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression
NCT ID: NCT01675908
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2012-08-22
2019-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Metal stent
Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
Stent Dysfunction
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
Complications
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
Plastic Stent
At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
Stent Dysfunction
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
Complications
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
Interventions
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Stent Dysfunction
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
Complications
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
Eligibility Criteria
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Inclusion Criteria
2. Patients 19 yrs of age and older
3. Serum bilirubin \> 2mg/dl
4. CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
Exclusion Criteria
2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication
3. Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day)
4. Ongoing or planned neoadjuvant therapy
5. Cholangitis at presentation or coagulopathy needing reversal medication
6. Post-surgical anatomy
7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
19 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
University of Maryland, Baltimore
OTHER
AdventHealth
OTHER
Responsible Party
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Principal Investigators
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shyam varadarajulu, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Hospital Center for Interventional Endoscopy
Locations
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Florida Hospital
Orlando, Florida, United States
Countries
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Other Identifiers
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356090
Identifier Type: -
Identifier Source: org_study_id
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