Prospective Evaluation of Idiopathic Pancreatitis: Role o... | NCT00609726

Studies
Prospective Evaluation of Idiopathic Pancreatitis: Role of Endoscopic Ultrasonography

NCT00609726

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Jan 25, 2016Estimated

Enrollment

199Actual

Phase

Not provided

Conditions

Gallbladder Disease
Pancreatitis

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
228552	Other Identifier	Institutional OGCA Reference Number

Status Module

Record Verification Date

Jan 2015

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

Dec 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 24, 2008

First Submission Date that Met QC Criteria

Feb 6, 2008

First Posted Date

Feb 7, 2008Estimated

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

Jan 21, 2016

Last Update Posted Date

Jan 25, 2016Estimated

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

The purpose of the study is to determine the best evaluation for patients with idiopathic (unexplained) pancreatitis.

Detailed Description

The study evaluates the role of endoscopic ultrasonography, given that the minimally invasive procedures can diagnosis gallbladder disease as well as pancreatitis abnormalities.

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

199Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of current clinical practice for patients with idiopathic pancreatitis		3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients referred to the principal investigator for unexplained pancreatitis will be enrolled.

Exclusion Criteria:

There are no gender nor racial exclusion.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men and women diagnosed with unexplained pancreatitis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles M Wilcox, M.D.	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama		Birmingham	Alabama	35294	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27325219	Derived	Wilcox CM, Seay T, Kim H, Varadarajulu S. Prospective Endoscopic Ultrasound-Based Approach to the Evaluation of Idiopathic Pancreatitis: Causes, Response to Therapy, and Long-term Outcome. Am J Gastroenterol. 2016 Sep;111(9):1339-48. doi: 10.1038/ajg.2016.240. Epub 2016 Jun 21.

ID	Term
D005705	Gallbladder Diseases
D010195	Pancreatitis

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D010182	Pancreatic Diseases