Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

Not Applicable

Completed

• Conditions: Pancreatic Duct Stricture; Bile Duct Stricture; Accuracy of Tissue Diagnosis
• Interventions: Procedure: ERCP with cholangiopancreatoscopy

• Registration Number: NCT01227382
• Lead Sponsor: University of Florida

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-25
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2015-06-29
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERCP with Cholangiopancreatoscopy	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Accurate Diagnoses of Cancer	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 Outcome Measures

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

Trial Locations

Locations (1)

Shands at UF Ensopcopy; 🇺🇸 Gainesville, Florida, United States