Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

This study is currently recruiting participants.

Verified March 2013 by University of Florida

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT01227382

First received: October 18, 2010

Last updated: March 13, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2010

Last Updated Date

March 13, 2013

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01227382 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

Official Title ^ICMJE

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)

Brief Summary

The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Crossover
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Accuracy of Tissue Diagnosis

Intervention ^ICMJE

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

Study Group/Cohort (s)

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

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
The subject is unable to give informed consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Peter Draganov, MD

352-273-9400

peter.draganov@medicine.ufl.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01227382

Other Study ID Numbers ^ICMJE

SpyBite

Has Data Monitoring Committee

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Draganov, MD

University of Flordia

Information Provided By

University of Florida

Verification Date

March 2013

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

To Top