Factors Predicting Positive Yields on Biliary Brush Cytol... | NCT00894348

Studies
Factors Predicting Positive Yields on Biliary Brush Cytology During Endoscopic Retrograde Cholangiopancreatography

NCT00894348

Sponsor

The Cleveland Clinic

Status

Completed

Last Update Posted

Mar 30, 2017Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Biliary Stricture

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 5, 2009

First Submission Date that Met QC Criteria

May 6, 2009

First Posted Date

May 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2017

Last Update Posted Date

Mar 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP.

Detailed Description

There are only 3 studies available that have tried to evaluate factors influencing the yield of brush cytology. Two of the 3 studied one parameter. The third study, which is also the largest, reported on 199 samples which the authors evaluated in a retrospect fashion. We plan to conduct a larger study assessing several other factors that have not been studied before. The study findings would help develop strategies to improve sensitivity of brush cytology specimens. This would ultimately result in more effective use of health care resources and improve patient outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP determine the factors associated with a positive yield of malignancy on biliary brush cytology obtained by ERCP		3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ERCP Patients

Exclusion Criteria:

Non ERCP Patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing an ERCP for evaluation of biliary strictures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mansour Parsi, M.D.	Staff Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Foundation		Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided