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Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

NCT01774019 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2023-04-10

Study results available
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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.

Conditions

  • Pancreatic Carcinoma

Interventions

DEVICE

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Guido Costamagna, MD · Fondazione Policlinico Universitario Agostino Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-20
Primary Completion
2021-12-13
Completion
2021-12-13

Countries

  • United States
  • Australia
  • Belgium
  • China
  • France
  • Hong Kong
  • India
  • Italy
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774019 on ClinicalTrials.gov