SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

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.

Official Title
-----------------
Preoperative Endoscopic Biliary Drainage With Self Expanding Metal Stents (SEMS) vs. Direct Surgical Resection for Patients With Severe Obstructive Jaundice

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: Endoscopic Retrograde Cholangiopancreatography
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEMS<br>Patients undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) with Self Expanding Metal Stents (SEMS) placement before standard of care surgical resection. | Procedure: Endoscopic Retrograde Cholangiopancreatography<br>* Undergo ERCP with SEMS placement<br>* Other names: ERCP;|
| Active Comparator: Standard of care surgical resection<br>Patients undergo standard of care surgical resection. | Other: Standard of care<br>* Undergo standard of care surgical resection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rates of Grade III or Higher | The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval. | At 30 days post-surgery | 
| Intraoperative Estimated Blood Loss | Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests. | At time of surgery |