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)

University of Florida1 site in 1 country26 target enrollmentNovember 2006

ConditionsAccuracy of Tissue Diagnosis Bile Duct Stricture Pancreatic Duct Stricture

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Accuracy of Tissue Diagnosis
Sponsor: University of Florida
Enrollment: 26
Locations: 1
Primary Endpoint: Percentage of Participants With Accurate Diagnoses of Cancer
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of Participants With Accurate Diagnoses of Cancer

Time Frame: up to 7 days after the procedure

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.