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Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

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ClinicalTrials.gov Identifier: NCT02238847
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 24, 2015
Actual Primary Completion Date : February 21, 2018
Actual Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Successful pre-operative biliary drainage defined as absence of reinterventions for the management of biliary obstructive symptoms. [ Time Frame: From stent placement until surgery (for patients undergoing surgery) or From stent placement until transition to palliation (for patients transitioning to palliative management) - Range for both groups: 2-7 months ]

    Successful pre-operative biliary drainage defined as absence of reinterventions for the management of biliary obstructive symptoms.

    • For patients undergoing surgery: from stent placement until surgery
    • For patients transitioning to palliative management: from stent placement until transition to palliation


Secondary Outcome Measures :
  1. Occurrence and severity of adverse events [ Time Frame: Procedure - up to 1 year after initial stent placement ]
    Adverse events will be assessed in terms of rate of occurrence and severity related to the stent and/or stenting procedure.

  2. Occurrence and severity of surgical complications [ Time Frame: At surgery ]
  3. Occurrence and severity of peri-surgical complications [ Time Frame: Procedure - 30 days post surgery ]
    Peri-surgical complications will be assessed in terms of rate of occurrence and severity from the time of procedure and up to 30 days after surgery.

  4. Stent Placement Success [ Time Frame: Procedure ]
    Stent Placement Success: ability to deploy the stent in a satisfactory position across the stricture.

  5. Improvement of biliary obstructive symptoms as relative to baseline [ Time Frame: Week 1 - surgery or transition to palliation as applicable ]
    Improvement of biliary obstructive symptoms during stent indwell at Week 1 and Monthly until surgery or transition to palliation as applicable, compared to Baseline

  6. Improvement of Laboratory Liver Function Tests (LFTs) as relative to baseline [ Time Frame: Week 1 - surgery or transition to palliation as applicable ]
    Improvement of Laboratory Liver Function Tests (LFTs) until surgery for patients undergoing surgery, and at Week 1 and Monthly until transition to palliation, and at 1 year after stent placement for patients not undergoing surgery.

  7. Number of biliary re-interventions [ Time Frame: Baseline - up to 1 year after initial stent placement ]
  8. Ability to complete neoadjuvant therapy as intended without stent related interruptions of neoadjuvant therapy [ Time Frame: Baseline - surgery (an expected average of 3-5 months) ]
  9. Stent migration rate [ Time Frame: Procedure - surgery or transition to palliation (an expected average of 3-5 months) ]
  10. Assessment by surgeon of interference, if any, of SEMS on time to surgery and/or success of pancreaticoduodenectomy [ Time Frame: Procedure - surgery (an expected average of 3-5 months) ]
  11. For patients transitioning to palliative management: Successful biliary drainage defined as absence of reinterventions for the management of biliary obstructive symptoms from stent placement to 1 year after stent placement [ Time Frame: Procedure - up to 1 year after initial stent placement ]
  12. Type of biliary re-interventions [ Time Frame: Baseline - up to 1 year after initial stent placement ]
  13. Reason of biliary re-interventions [ Time Frame: Baseline - up to 1 year after initial stent placement ]
  14. Timing of biliary re-interventions [ Time Frame: Baseline - up to 1 year after initial stent placement ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238847


Locations
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United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Belgium
CUB Hopital Erasme
Brussels, Belgium, 1070
Canada, Quebec
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, Canada, H2X 0A9
Italy
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy, 00168
Japan
Tokyo University Hospital
Tokyo, Japan, 113-8655
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Yousuke Nakai, MD, PhD Tokyo University
Principal Investigator: Dong-Wan Seo, MD Asan Medical Center

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02238847     History of Changes
Other Study ID Numbers: 90905950
E7034 ( Other Identifier: Boston Scientific )
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Boston Scientific Corporation:
Pancreatic
Pancreatic Cancer
Preoperative Biliary Drainage
Neoadjuvant Therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases