NCT01227382

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 3, 2015

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

8.5 years

First QC Date

October 18, 2010

Results QC Date

June 29, 2015

Last Update Submit

July 29, 2015

Conditions

Accuracy of Tissue DiagnosisBile Duct StricturePancreatic Duct Stricture

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Procedure Technical Success

    day 1

  • Total Procedure Time

    120 minutes

  • Total Cholangioscopy Time

    60 minutes

  • Cholangioscopy Visualization Time

    30 minutes

  • Sampling Times for Each Device

    15 minutes

  • +1 more secondary outcomes

Study Arms (1)

ERCP with Cholangiopancreatoscopy

OTHER

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.

Procedure: ERCP with cholangiopancreatoscopy

Interventions

ERCP with cholangiopancreatoscopyPROCEDURE

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

Also known as: Endoscopic Retrograde Cholangiopancreatography, ERCP
ERCP with Cholangiopancreatoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
  • The subject is unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands at UF Ensopcopy

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Draganov PV, Chauhan S, Wagh MS, Gupte AR, Lin T, Hou W, Forsmark CE. Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study. Gastrointest Endosc. 2012 Feb;75(2):347-53. doi: 10.1016/j.gie.2011.09.020.

    PMID: 22248602DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Dr. Peter V. Draganov
Organization
University of Florida
Peter.Draganov@medicine.ufl.edu
(352) 273-9472

Study Officials

  • Peter Draganov, MD

    University of Flordia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 25, 2010

Study Start

November 1, 2006

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 3, 2015

Results First Posted

August 3, 2015

Record last verified: 2015-07

Locations

US(1)