Status:
TERMINATED
SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive j...
Detailed Description
PRIMARY OBJECTIVES: I. To compare the 30-day overall complication rates between patients with severe obstructive jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal...
Eligibility Criteria
Inclusion
- Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care
- Serum bilirubin \> 10 mg/dl
- Adequate birth control
Exclusion
- Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI)
- Patients anticipated to require vascular reconstruction
- Patients with cholangitis
- Patients for whom surgery is deemed inappropriate by surgeon
- Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL
- Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC)
- Patients with low performance score (Karnofsky performance status scale \< 50)
- Patients with known preexisting liver disease with associated elevated bilirubin
- Patients who are pregnant or actively breast feeding
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03820544
Start Date
September 1 2017
End Date
April 4 2019
Last Update
April 30 2025
Active Locations (1)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107