Acute Pancreatitis Patient Registry To Examine Novel Ther... | NCT03075631

Studies
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2

NCT03075631

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

May 6, 2020Actual

Enrollment

1,183Actual

Phase

Not provided

Conditions

Pancreatitis

Interventions

Questionnaire

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

May 2020

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

Mar 4, 2020Actual

Completion Date

Mar 4, 2020Actual

First Submitted Date

Feb 2, 2017

First Submission Date that Met QC Criteria

Mar 3, 2017

First Posted Date

Mar 9, 2017Actual

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

May 5, 2020

Last Update Posted Date

May 6, 2020Actual

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

This study is an ancillary of APPRENTICE. This will be the international based study.

Detailed Description

This study is an ancillary of APPRENTICE. This will be the international based study. The initial study design with discussions about the different variables to be included into our prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. We now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited.University of Pittsburgh will be responsible for collecting all required regulatory documents from other sites. Developing templates for questionnaires and other data collection forms. Will train approved sites on procedures. The coordinating center will be the recipient of de-identified data and will not be involved in the collection of data.

Note that copies of training records, licenses, certificates should be maintained in the study regulatory binder and are subject to audit by the Research Conduct and Compliance Office (RCCO).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,183Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Acute Pancreatitis		Patients with Acute Pancreatitis	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaires	Patients with Acute Pancreatitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with pancreatic necrosis as assessed by their clinical course.	Evaluation of the existing risks, predictive scores, and markers of severe disease.	12 months
Number of patients with persistent organ failure as assessed by their clinical course.	Evaluation of the current management and outcomes of acute pancreatitis around the world.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The diagnosis of AP based upon presence of two out of the three following criteria:
1. Abdominal pain typical to AP
2. Serum amylase or lipase levels more than three times the upper limit of normal
3. Imaging findings suggestive of AP
Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).

Exclusion Criteria:

Age under 18 years
Unwilling to provide consent by patient or his/her proxy
Presence of pancreatic cancer
Presence of chronic pancreatitis
Occurrence of AP following a multiple trauma episode
Having history of organ transplant
Presence of any cancer which required chemotherapy or radiation therapy in the past year.

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

Patients with Acute Pancreatitis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georgios I Papachristou, MD	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC Presbyterian		Pittsburgh	Pennsylvania	15213	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The results will be shared with the other IRB approved sites associated with this study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided