Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

This study has been completed.
Information provided by (Responsible Party):
University of Florida Identifier:
First received: October 18, 2010
Last updated: July 29, 2015
Last verified: July 2015
The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.

Condition Intervention
Accuracy of Tissue Diagnosis
Bile Duct Stricture
Pancreatic Duct Stricture
Procedure: ERCP with cholangiopancreatoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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)

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 26
Study Start Date: November 2006
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01227382

United States, Florida
Shands at UF Ensopcopy
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Principal Investigator: Peter Draganov, MD University of Flordia
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Florida 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

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical processed this record on November 27, 2015