CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
WallFlex™ Biliary RX Fully Covered/Uncovered Stent Systemdevice
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age 18 or older
  • ✓Suspicion of pancreatic adenocarcinoma with distal biliary obstruction
  • ✓Distal biliary obstruction consistent with pancreatic cancer
  • ✓Likely indicated for neoadjuvant treatment
Key exclusion· 6
  • ✕Benign biliary strictures
  • ✕Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
  • ✕Surgically altered anatomy precluding ERCP
  • ✕Prior biliary drainage with metal stent or multiple plastic stents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02238847
NCT02238847N/ACompleted
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Sep 12, 2014·Updated Feb 17, 2020

In Brief

A clinical study evaluating WallFlex™ Biliary RX Fully Covered/Uncovered Stent System for Pancreatic Cancer. Completed, enrolled 119 participants across 9 sites in 6 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesBelgium, Canada, Italy, Japan, South Korea, United States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 12, 2014
Enrollment StartMar 24, 2015
Primary CompletionFeb 21, 2018
Study CompletionApr 10, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.8 years ago

Interventions

WallFlex™ Biliary RX Fully Covered/Uncovered Stent Systemdevice

Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System