Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

NCT ID: NCT01227382

Last Updated: 2015-08-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Accuracy of Tissue Diagnosis Bile Duct Stricture Pancreatic Duct Stricture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

ERCP with cholangiopancreatoscopy

Intervention Type PROCEDURE

Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps

Interventions

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ERCP with cholangiopancreatoscopy

Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps

Intervention Type PROCEDURE

Other Intervention Names

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Endoscopic Retrograde Cholangiopancreatography ERCP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Draganov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Flordia

Locations

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Shands at UF Ensopcopy

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22248602 (View on PubMed)

Other Identifiers

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SpyBite

Identifier Type: -

Identifier Source: org_study_id

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