Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01227382
First received: October 18, 2010
Last updated: July 29, 2015
Last verified: July 2015
Results First Received: June 29, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Accuracy of Tissue Diagnosis
Bile Duct Stricture
Pancreatic Duct Stricture
Intervention: Procedure: ERCP with cholangiopancreatoscopy

  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
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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
Indeterminate Biliary Lesions Requiring Tissue Sampling Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.

Participant Flow:   Overall Study
    Indeterminate Biliary Lesions Requiring Tissue Sampling  
STARTED     26  
COMPLETED     26  
NOT COMPLETED     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.
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Reporting Groups
  Description
Indeterminate Biliary Lesions Requiring Tissue Sampling Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.

Baseline Measures
    Indeterminate Biliary Lesions Requiring Tissue Sampling  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Mean (Standard Deviation)
  67.92  (13.37)  
Gender  
[units: participants]
 
Female     11  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Accurate Diagnoses of Cancer   [ Time Frame: up to 7 days after the procedure ]

2.  Secondary:   Procedure Technical Success   [ Time Frame: day 1 ]

3.  Secondary:   Total Procedure Time   [ Time Frame: 120 minutes ]

4.  Secondary:   Total Cholangioscopy Time   [ Time Frame: 60 minutes ]

5.  Secondary:   Cholangioscopy Visualization Time   [ Time Frame: 30 minutes ]

6.  Secondary:   Sampling Times for Each Device   [ Time Frame: 15 minutes ]

7.  Secondary:   Adverse Events   [ Time Frame: 24 hours ]


  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: Dr. Peter V. Draganov
Organization: University of Florida
phone: (352) 273-9472
e-mail: Peter.Draganov@medicine.ufl.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01227382     History of Changes
Other Study ID Numbers: SpyBite
Study First Received: October 18, 2010
Results First Received: June 29, 2015
Last Updated: July 29, 2015
Health Authority: United States: Institutional Review Board