Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Completed · Not applicable

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT02238847

Run by

Boston Scientific Corporation

People needed

119

Starts

2015-03-24

Expected to finish

2018-04-10

Last updated by the study team

2020-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Medical Center — Indianapolis, Indiana, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• CUB Hopital Erasme — Brussels, Belgium
• Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital — Montreal, Quebec, Canada
• Fondazione Policlinico Universitario Agostino Gemelli — Rome, Italy
• Tokyo University Hospital — Tokyo, Japan
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.