Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

Study Overview
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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.

Official Title
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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)

Conditions
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Accuracy of Tissue Diagnosis, Bile Duct Stricture, Pancreatic Duct Stricture

Intervention / Treatment
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* Procedure: ERCP with cholangiopancreatoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ERCP with Cholangiopancreatoscopy<br>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<br>* Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps<br>* Other names: ERCP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Accurate Diagnoses of Cancer | 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. | up to 7 days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Technical Success | 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. | day 1 | 
| Total Procedure Time | The total time to perform ERCP | 120 minutes | 
| Total Cholangioscopy Time | This is the total time it takes for the dye to be performed during the ERCP. | 60 minutes | 
| Cholangioscopy Visualization Time | The portion of the total ERCP time spent on Cholangioscopy visualization. | 30 minutes | 
| Sampling Times for Each Device | 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). | 15 minutes | 
| Adverse Events | 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. | 24 hours |