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Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01227382
First received: October 18, 2010
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention
Accuracy of Tissue Diagnosis
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and stricture sampling

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • accuracy of SpyBite biopsy forceps [ Time Frame: at scheduled Endoscopic Retrograde Cholangiopancreatography (ERCP) visit approximately 4-5 hours. ] [ Designated as safety issue: No ]
    The accuracy of the Spybite Biopsy forceps will be compared to cytology brush and RJ3 biopsy forcep sampling of any stricture found on Endoscopic Retrograde Cholangiopancreatography (ERCP)


Estimated Enrollment: 25
Study Start Date: November 2006
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ERCP with Cholangiopancreatoscopy and stricture sampling
Those subjects who have been scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangiopancreatoscopy for evaluation of a bile duct ot pancreatic duct stricture
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and stricture sampling
Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Those subjects who have a bile duct or pancreatic duct stricture who are scheduled to undergo an ERCP with Cholangiopancreatoscopy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227382

Contacts
Contact: Peter Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands at UF Ensopcopy Recruiting
Gainesville, Florida, United States, 32610
Contact: Peter Draganov, MD    352-273-9400    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter Draganov, MD         
Sub-Investigator: Chris Forsmark, MD         
Sub-Investigator: Mamoon Elbedawi, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Flordia
  More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01227382     History of Changes
Other Study ID Numbers: SpyBite
Study First Received: October 18, 2010
Last Updated: October 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014