Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

Bile Duct Stricture Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227382
• Other study ID #: SpyBite
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: July 29, 2015
• Start date: November 2006
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Accuracy of Tissue Diagnosis
• Bile Duct Stricture
• Constriction, Pathologic
• Pancreatic Duct Stricture

Intervention

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

Locations

Country	Name	City	State
United States	Shands at UF Ensopcopy	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Total Procedure Time	The total time to perform ERCP	120 minutes	No
Secondary	Total Cholangioscopy Time	This is the total time it takes for the dye to be performed during the ERCP.	60 minutes	No
Secondary	Cholangioscopy Visualization Time	The portion of the total ERCP time spent on Cholangioscopy visualization.	30 minutes	No
Secondary	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	No
Secondary	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	Yes