Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01227382
First received: October 18, 2010
Last updated: October 21, 2014
Last verified: October 2014

October 18, 2010
October 21, 2014
November 2006
September 2016   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01227382 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

Those subjects who have a bile duct or pancreatic duct stricture who are scheduled to undergo an ERCP with Cholangiopancreatoscopy

Accuracy of Tissue Diagnosis
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and stricture sampling
Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps
ERCP with Cholangiopancreatoscopy and stricture sampling
Those subjects who have been scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangiopancreatoscopy for evaluation of a bile duct ot pancreatic duct stricture
Intervention: Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and stricture sampling
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.
 
Recruiting
25
September 2016
September 2016   (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
No
Contact: Peter Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu
United States
 
NCT01227382
SpyBite
No
University of Florida
University of Florida
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Principal Investigator: Peter Draganov, MD University of Flordia
University of Florida
October 2014

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