Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 21, 2018

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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
  • 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.
  • 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
  • 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
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Scientific Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yousuke Nakai, MD, PhD, Principal Investigator, Tokyo University
    • Dong-Wan Seo, MD, Principal Investigator, Asan Medical Center

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