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Endoscopic Retrograde Cholangiography for Bile Duct Cancer (INTERCPT Trial)
N/A
Waitlist Available
Led By B. Joseph Elmunzer
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 months after initial procedure
Awards & highlights
INTERCPT Trial Summary
The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.
Eligible Conditions
- Bile Duct Cancer
- Hilar Lymphadenopathy
- Biliary Strictures
INTERCPT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-3 months after initial procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 months after initial procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful biliary drainage
Secondary outcome measures
Adequate tissue diagnosis
Adverse events
Alternate definition of successful biliary drainage
+1 moreINTERCPT Trial Design
2Treatment groups
Active Control
Group I: Endoscopic Retrograde CholangiographyActive Control1 Intervention
Subjects randomized to this arm will undergo ERC as the first drainage intervention.
Group II: Percutaneous Transhepatic DrainageActive Control1 Intervention
Subjects randomized to this arm will undergo PTBD as the first drainage intervention.
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Who is running the clinical trial?
Yale UniversityOTHER
1,870 Previous Clinical Trials
2,742,973 Total Patients Enrolled
Vanderbilt UniversityOTHER
706 Previous Clinical Trials
6,143,490 Total Patients Enrolled
Case Western Reserve UniversityOTHER
300 Previous Clinical Trials
246,598 Total Patients Enrolled
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