At a glance
ClinicalIndex Comparison RecordN/ACompleted· 284 enrolled
Drug / intervention
WallFlex™ Biliary RX Fully Covered/Uncovered Stent Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
In Brief
A clinical study evaluating WallFlex™ Biliary RX Fully Covered/Uncovered Stent System for Pancreatic Carcinoma. Completed, enrolled 284 participants across 11 sites in 9 countries.
Detailed Summary
The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Carcinoma
CountriesAustralia, Belgium, China, France, Hong Kong, India, Italy, Japan, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionDec 2021
TodayJul 2026
First PostedJan 23, 2013
Enrollment StartFeb 20, 2013
Primary CompletionDec 13, 2021
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 13.4 years ago
Interventions
WallFlex™ Biliary RX Fully Covered/Uncovered Stent Systemdevice