Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Status:	Completed
Conditions:	Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/27/2018
Start Date:	March 24, 2015
End Date:	April 10, 2018

Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to
Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary
obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.

Inclusion Criteria:

- Age 18 or older

- Patient indicated for biliary metal stent placement for the treatment of jaundice
and/or cholestasis

- Willing and able to comply with the study procedures and provide written informed
consent to participate in the study

- Suspicion of pancreatic adenocarcinoma

- Likely indicated for neoadjuvant treatment

- Distal biliary obstruction consistent with pancreatic cancer

- Location of distal biliary obstruction such that it would allow the proximal end of a
stent to be positioned at least 2 cm from the hilum

- Endoscopic and surgical treatment to be provided at the same institution

Exclusion Criteria:

- Benign biliary strictures

- Malignancy secondary to Intraductal Papillary Mucinous Neoplasm

- Surgically altered anatomy where ERCP is not possible

- Previous biliary drainage using a SEMS or multiple plastic stents

- Contraindications for endoscopic techniques

- Patients who are currently enrolled in another investigational trial that would
directly interfere with the current study

- Pregnancy

We found this trial at

sites

Virginia Mason Medical Center

Seattle, Washington 98101

(888) 862-2737