Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Complication Rates of Grade III or Higher
Study Overview
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 jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.
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 stents (SEMS) and patients undergoing direct surgical resection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
SEMS
Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection.
Intervention: Endoscopic Retrograde Cholangiopancreatography (Procedure)
Standard of care surgical resection
Patients undergo standard of care surgical resection.
Intervention: Standard of care (Other)
Outcomes
Primary Outcomes
Complication Rates of Grade III or Higher
Time Frame: At 30 days post-surgery
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Intraoperative Estimated Blood Loss
Time Frame: At time of surgery
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
Secondary Outcomes
No secondary outcomes reported