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Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01038713
First received: December 23, 2009
Last updated: June 21, 2016
Last verified: June 2016
Results First Received: June 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Device: Biliary stent placement

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The protocol initially was designed to measure five groups - we elected not to study patients with unresectable disease and thus only patients with presumed resectable disease are included

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
94 patients recruited for the study. 63 were randomized into three arms

Reporting Groups
  Description
Resectable; Plastic Stent

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.

Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Resectable; Uncovered Metal Stent

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.

Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Resectable; Fully Covered Metal Stent

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.

Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.


Participant Flow:   Overall Study
    Resectable; Plastic Stent   Resectable; Uncovered Metal Stent   Resectable; Fully Covered Metal Stent
STARTED   26   20   17 
COMPLETED   21   17   16 
NOT COMPLETED   5   3   1 
Patient to hospice                1                1                1 
Lost to Follow-up                3                0                0 
Neuroendocrine Tumor                0                1                0 
died from PEP                0                1                0 
Autoimmune Pancreatitis                1                0                0 



  Baseline Characteristics
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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
Resectable; Plastic Stent

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.

Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Resectable; Uncovered Metal Stent

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.

Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Resectable; Fully Covered Metal Stent

Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.

Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.

Total Total of all reporting groups

Baseline Measures
   Resectable; Plastic Stent   Resectable; Uncovered Metal Stent   Resectable; Fully Covered Metal Stent   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   17   16   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.9  (9.67)   64.8  (8.47)   67.2  (11.4)   65.9  (9.74) 
Gender 
[Units: Participants]
       
Female   10   6   7   23 
Male   11   11   9   31 
Region of Enrollment 
[Units: Participants]
       
United States   21   17   16   54 


  Outcome Measures
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1.  Primary:   Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.   [ Time Frame: Time of stent occlusion, attempted surgical resection or patient death to 300 days ]

2.  Secondary:   Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.   [ Time Frame: Costs measured up to 500 days ]

3.  Secondary:   Determine the Days of Hospitalization Following Stent Placement   [ Time Frame: From stent placement up to 500 days post stent ]

4.  Secondary:   Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents   [ Time Frame: Time from stent placement to 500 days ]

5.  Secondary:   Assess Rate of Acute Cholecystitis Associated With Each Type of Stent   [ Time Frame: time from stent placement to 500 days ]


  Serious Adverse Events


  Other Adverse Events


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


Results Point of Contact:  
Name/Title: Timothy Gardner
Organization: Dartmouth-Hitchcock Medical Center
phone: 603-650-6472
e-mail: timothy.b.gardner@hitchcock.org



Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01038713     History of Changes
Other Study ID Numbers: 2009-01
Study First Received: December 23, 2009
Results First Received: June 9, 2016
Last Updated: June 21, 2016
Health Authority: United States: Institutional Review Board