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Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590394
Recruitment Status : Terminated (Difficulty in enrolling subjects and transporting scope for sterilization)
First Posted : May 3, 2012
Results First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Olympus America, Inc.
Information provided by (Responsible Party):
Christopher J. Gostout, Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stricture
Obstruction
Cancer
Intervention Device: Large plastic biliary stent
Enrollment 3
Recruitment Details Patients were enrolled at Mayo Clinic in Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description:
A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pancreatic Cancer Patients
Hide Arm/Group Description A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
All-Cause Mortality
Pancreatic Cancer Patients
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Serious Adverse Events
Pancreatic Cancer Patients
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pancreatic Cancer Patients
Affected / at Risk (%)
Total   0/3 (0.00%) 
The study was terminated early due to difficulty in enrolling subjects and transporting the scope for sterilization.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher J. Gostout
Organization: Mayo Clinic
Phone: 507-284-7647
EMail: gostout.christopher@mayo.edu
Layout table for additonal information
Responsible Party: Christopher J. Gostout, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01590394    
Other Study ID Numbers: 11-003154
First Submitted: April 30, 2012
First Posted: May 3, 2012
Results First Submitted: September 18, 2017
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017