Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

February 14, 2020 updated by: Boston Scientific Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • CUB Hôpital Erasme
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
  • Japan
      • Tokyo, Japan, 113-8655
        • Tokyo University Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • The Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: WallFlex Biliary RX Fully Covered Stent System

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
Time Frame: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related or Stent-related Serious Adverse Events
Time Frame: From stent placement procedure up to one year after stent placement procedure
Serious adverse events related to the stent placement procedure or to the stent
From stent placement procedure up to one year after stent placement procedure
Technical Success
Time Frame: During the Stent Placement Procedure
Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.
During the Stent Placement Procedure
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
Time Frame: From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS
The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention
From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS
Number of Participants With Stent Migration
Time Frame: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
The number of participants with stent migration
At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
Time Frame: At the time of curative intent surgery (CIS) (median 110 days to CIS)
The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.
At the time of curative intent surgery (CIS) (median 110 days to CIS)
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
Time Frame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery
For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.
From stent placement to one year after stent placement for participants not undergoing curative intent surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Yousuke Nakai, MD, PhD, Tokyo University
  • Principal Investigator: Dong-Wan Seo, MD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 24, 2015

Primary Completion (ACTUAL)

February 21, 2018

Study Completion (ACTUAL)

April 10, 2018

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (ESTIMATE)

September 12, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 14, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90905950
  • E7034 (OTHER: Boston Scientific)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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