Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01227382

Enrollment

Registered

2010-10-25

Start date

2006-11-30

Completion date

2015-05-31

Last updated

2015-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREERCP with cholangiopancreatoscopy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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).
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.
Cholangioscopy Visualization Time	30 minutes	The portion of the total ERCP time spent on Cholangioscopy visualization.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Indeterminate Biliary Lesions Requiring Tissue Sampling Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.	26
Total	26

Baseline characteristics

Characteristic	Indeterminate Biliary Lesions Requiring Tissue Sampling
Age, Continuous	67.92 years STANDARD_DEVIATION 13.37
Region of Enrollment United States	26 participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	2 / 26
serious Total, serious adverse events	1 / 26

Outcome results

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.

Time frame: up to 7 days after the procedure