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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Accurate Diagnoses of Cancer
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: ERCP with cholangiopancreatoscopy (Procedure)
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.
Secondary Outcomes
- Total Procedure Time(120 minutes)
- Total Cholangioscopy Time(60 minutes)
- Adverse Events(24 hours)
- Sampling Times for Each Device(15 minutes)
- Cholangioscopy Visualization Time(30 minutes)
- Procedure Technical Success(day 1)