Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Boston Scientific

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02238847

90905950

E7034 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

WallFlex Biliary RX Fully Covered Stent System

Active Comparator group

Description:

Patients in this group will receive a fully covered study SEMS (self-expanding metal stent) Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System

Treatment:

Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

WallFlex Biliary RX Uncovered Stent System

Active Comparator group

Description:

Patients in this group will receive an uncovered study SEMS (self-expanding metal stent). Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System

Treatment:

Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System