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Completed

NCT Number: NCT01227382

Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

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

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Key information

Conditions

Accuracy of Tissue Diagnosis Bile Duct Stricture Pancreatic Duct Stricture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shands at UF Ensopcopy

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP with cholangiopancreatoscopy

Procedure

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

Other names: Endoscopic Retrograde Cholangiopancreatography, ERCP

Primary outcomes

  1. 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

  1. Procedure Technical Success

    Time frame: 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.

  2. Total Procedure Time

    Time frame: 120 minutes

    The total time to perform ERCP

  3. Total Cholangioscopy Time

    Time frame: 60 minutes

    This is the total time it takes for the dye to be performed during the ERCP.

  4. Cholangioscopy Visualization Time

    Time frame: 30 minutes

    The portion of the total ERCP time spent on Cholangioscopy visualization.

  5. Sampling Times for Each Device

    Time frame: 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).

  6. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2010
Registry last updated
Aug 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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