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

October 18, 2010
July 29, 2015
November 2006
May 2015   (final data collection date for primary outcome measure)
Percentage of Participants With Accurate Diagnoses of Cancer [ Time Frame: up to 7 days after the procedure ] [ Designated as safety issue: No ]
The diagnostic accuracy of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps sampling of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP). All three methods were used at baseline to obtain a sample for the determination of cancer vs. no cancer.
accuracy of SpyBite biopsy forceps [ Time Frame: at scheduled Endoscopic Retrograde Cholangiopancreatography (ERCP) visit approximately 4-5 hours. ] [ Designated as safety issue: No ]
The accuracy of the Spybite Biopsy forceps will be compared to cytology brush and RJ3 biopsy forcep sampling of any stricture found on Endoscopic Retrograde Cholangiopancreatography (ERCP)
Complete list of historical versions of study NCT01227382 on ClinicalTrials.gov Archive Site
  • Procedure Technical Success [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    The procedure technical success was defined when all of the following criteria were met: Successful advancement of the cholangioscope to the desired target, adequate cholangioscopic visualization of the area of interest, and successful applications of of all sampling maneuvers with visible tissue seen macroscopically when obtaining mini forceps and standard forceps biopsy samples.
  • Total Procedure Time [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    The total time to perform ERCP
  • Total Cholangioscopy Time [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    This is the total time it takes for the dye to be performed during the ERCP.
  • Cholangioscopy Visualization Time [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The portion of the total ERCP time spent on Cholangioscopy visualization.
  • Sampling Times for Each Device [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    The sampling time of the Spybite Biopsy forceps was compared to both the cytology brush and the RJ3 biopsy forceps of any stricture or biliary lesions found on Endoscopic Retrograde Cholangiopancreatography (ERCP).
  • Adverse Events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Adverse events were prospectively evaluated at the end of the procedure, at discharge from the endoscopy unit, and by telephone call 24 hours post procedure. Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria.
Not Provided
Not Provided
Not Provided
 
Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods
Prospective Evaluation of the Accuracy of Spybite Biopsy Forceps for the Tissue Diagnosis of Lesion of the Pancreatobiliary System. ( Part of the "The Clinical Utility of Cholangioscopy and Pancreatoscopy in the Diagnosis and Treatment of Pancreaticobiliary Disorders" Study)
The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.
The participants will undergo an Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy and evaluation of a bile duct or pancreatic duct stricture with three different types of techniques for biopsy: SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Accuracy of Tissue Diagnosis
  • Bile Duct Stricture
  • Pancreatic Duct Stricture
Procedure: ERCP with cholangiopancreatoscopy
Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps
Other Names:
  • Endoscopic Retrograde Cholangiopancreatography
  • ERCP
ERCP with Cholangiopancreatoscopy
The subjects who have been scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangiopancreatoscopy for evaluation of a bile duct or pancreatic duct stricture sampling.
Intervention: Procedure: ERCP with cholangiopancreatoscopy
Draganov PV, Chauhan S, Wagh MS, Gupte AR, Lin T, Hou W, Forsmark CE. Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study. Gastrointest Endosc. 2012 Feb;75(2):347-53. doi: 10.1016/j.gie.2011.09.020.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects is 18 years or older
  2. Scheduled to undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) wiht cholangioscopy and/or pancreatoscopy at the University of Florida Gainesville Florida as medically indicated.
  3. Lesion of the pancreatobiliary system that requires tissue sampling as medically indicated
  4. Subject myst be able to give informed consent

Exclusion Criteria:

  1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
  2. The subject is unable to give informed consent
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01227382
SpyBite
No
Not Provided
Not Provided
University of Florida
University of Florida
Not Provided
Principal Investigator: Peter Draganov, MD University of Flordia
University of Florida
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP