Accuracy of Tissue DiagnosisNCT01227382

Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

A study testing ERCP with cholangiopancreatoscopy in people with Accuracy of Tissue Diagnosis and Bile Duct Stricture, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Accuracy of Tissue Diagnosis, Bile Duct Stricture, Pancreatic Duct Stricture
What is being tested?: ERCP with cholangiopancreatoscopy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Nov 2006to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Shands at UF Ensopcopy
Gainesville, Florida, 32610

Other trials in United States

About this study

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)

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

Read the 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.

Conditions: Accuracy of Tissue Diagnosis, Bile Duct Stricture, Pancreatic Duct Stricture
Being tested: ERCP with cholangiopancreatoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ERCP with cholangiopancreatoscopyProcedure or surgery
Also called Endoscopic Retrograde Cholangiopancreatography, ERCP
Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps

Study groups in NCT01227382
Study group	Role	What they receive
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. Receives: Procedure: ERCP with cholangiopancreatoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 7 days after the procedure

Secondary outcomes (6)

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.
Measured: day 1
Total Procedure Time
The total time to perform ERCP
Measured: 120 minutes
Total Cholangioscopy Time
This is the total time it takes for the dye to be performed during the ERCP.
Measured: 60 minutes
Cholangioscopy Visualization Time
The portion of the total ERCP time spent on Cholangioscopy visualization.
Measured: 30 minutes
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).
Measured: 15 minutes
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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006May 2015

First posted25 Oct 2010 (estimated)
Study startNov 2006
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Accuracy of Tissue DiagnosisStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227382
Sponsor's protocol ID: SpyBite
Status last verified: Jul 2015
First submitted: 18 Oct 2010
Last updated: 3 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22248602

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01227382
Acronym / sponsor ID: SpyBite
Conditions: Accuracy of Tissue Diagnosis, Bile Duct Stricture, Pancreatic Duct Stricture
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: Nov 2006
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 3 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ERCP with Cholangiopancreatoscopy	Other	Procedure: ERCP with cholangiopancreatoscopyThe subjects who have been scheduled for an Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangiopancreatoscopy for evaluation of a bile duct or pancreatic duct stricture sampling.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ERCP with cholangiopancreatoscopyAlso: Endoscopic Retrograde Cholangiopancreatography, ERCPEndoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps	Procedure or surgery	ERCP with Cholangiopancreatoscopy

Primary outcome

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.

6 secondary outcomes

Procedure Technical Success
Time frame: day 1
Total Procedure Time
Time frame: 120 minutes
Total Cholangioscopy Time
Time frame: 60 minutes
Cholangioscopy Visualization Time
Time frame: 30 minutes
Sampling Times for Each Device
Time frame: 15 minutes
Adverse Events
Time frame: 24 hours

Results and safety

Results posted to the registry on 3 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Indeterminate Biliary Lesions Requiring Tissue Sampling	26	26

Primary outcome: Percentage of Participants With Accurate Diagnoses of Cancer

Time frame: up to 7 days after the procedure. Number. Unit: percentage of accurate diagnoses

Measure	Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the n = 26
Cytology brush	38.5
Standard forceps biopsy	53.9
Spybite biopsy	84.6

Population analysed: Percentage of participants with accurate diagnoses of cancer

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Indeterminate Biliary Lesions Requiring Tissue Sampling	1 of 26 (3.8%)	2 of 26 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22248602Draganov 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Draganov, MD principal investigator

University of Flordia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ERCP with cholangiopancreatoscopy in people with Accuracy of Tissue Diagnosis and Bile Duct Stricture, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Accurate Diagnoses of Cancer (time frame: up to 7 days after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.