EUS-CPN: A Retrospective Review | NCT00577564

Studies
EUS-CPN: A Retrospective Review

NCT00577564

Sponsor

Indiana University

Status

Completed

Last Update Posted

Sep 12, 2012Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Pancreatic Cancer

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

ID	Type	Description	Link
IRB #0606-59

Status Module

Record Verification Date

Sep 2012

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

Jul 2006

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 19, 2007

First Posted Date

Dec 20, 2007Estimated

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

Sep 11, 2012

Last Update Posted Date

Sep 12, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that have undergone this procedure in the last decade.

Detailed Description

Not provided

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

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of EUS-CPN procedures for each patient		over a ten year period

Secondary Outcomes

Measure	Description	Time Frame
Procedure-related complications		over a ten year period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any subject that has undergone EUS-CPN will be considered for this study.

Exclusion Criteria:

Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical) at an another institution.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients that underwent a EUS-CPN over a ten year period at Indiana University Medical Center will be considered.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia LeBlanc, MD, MPH	Indiana University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clarian: University Hospital		Indianpolis	Indiana	46202	United States

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided