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A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures (Wallstent)

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ClinicalTrials.gov Identifier: NCT01047332
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Inoperable Tumors of the Bile Duct
Interventions: Device: Partially Covered Wallstent
Device: Uncovered Wallstent

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Uncovered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Partially Covered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).

Participant Flow:   Overall Study
    Uncovered Wallstent   Partially Covered Wallstent
STARTED   61   68 
COMPLETED   4 [1]   4 [1] 
NOT COMPLETED   57   64 
SEMS Obstruction                11                20 
Died Unobstructed                38                41 
Lost to Follow-up                8                3 
[1] Alive at final follow-up



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Uncovered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Partially Covered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Total Total of all reporting groups

Baseline Measures
   Uncovered Wallstent   Partially Covered Wallstent   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   68   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (13)   66  (14)   66  (14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      30  49.2%      38  55.9%      68  52.7% 
Male      31  50.8%      30  44.1%      61  47.3% 


  Outcome Measures

1.  Primary:   Time to Recurrent Biliary Obstruction   [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]

2.  Secondary:   Patient Survival   [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]

3.  Secondary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: From time of stent placement to participant death or lost to follow-up (up to 1302 days) ]

4.  Secondary:   Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism   [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David L. Carr-Locke, MD, FRCP
Organization: Brigham and Women’s Hospital
e-mail: dcarrlocke@chpnet.org


Publications of Results:

Responsible Party: David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01047332     History of Changes
Other Study ID Numbers: BS-816
First Submitted: January 8, 2010
First Posted: January 12, 2010
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017