Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE) (APPRENTICE)

April 2, 2020 updated by: David Whitcomb, University of Pittsburgh
The management of acute pancreatitis is mainly based on expert opinions; large randomized controlled trials are missing and novel therapeutic approaches are considered necessary. This study will evaluate the current management and outcomes of acute pancreatitis around the world.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The initial study design with discussions about the different variables to be included into the investigators' 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. The investigators 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. The webinar will be chaired by Dr. Papachristou at the University of Pittsburgh and again sponsored by CAPER. The investigators plan to discuss previous experience with collaborative, multi-continent, clinical studies in pancreas research, details of IRB submission, access and technical aspects of REDCap, and review the current datasheet for any further edits needed.

Following this, each investigator will initiate the process of applying for approval to the Institutional Review Board of his/her center. University of Pittsburgh will share their accepted, ongoing PROOF protocol as a reference. Investigators/centers with active protocol approval will start enrolling patients. The investigators plan to have a Webinar every 3-4 months and/or schedule a working group meeting at DDW in May 2015 and/or EPC in June 2015 pending on attendance of these meetings by the investigators. Finally, the investigators will present all the above steps and the progress made by our working group in 2015 PancreasFest in Pittsburgh, PA.

The initial aim of this study is to develop a core of highly motivated investigators throughout the world and enroll large number of subjects into an Internet-based database. The study team plans to monitor data recording closely and prepare our first manuscript when we reach a critical number of patients. The future goal is to maintain this collaborative core and expand into designing randomized controlled trials addressing critical questions in the management of acute pancreatitis as well as applying for funding.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
623

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Acute Pancreatitis, ages 18 and over.

Description

Inclusion Criteria:

  1. 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
  2. Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Acute Pancreatitis
Patients with Acute Pancreatitis.
Behavioral: Questionnaires
Questionnaires

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with persistent organ failure as assessed by their clinical course.
Time Frame: 12 months
Evaluation of the existing risks, predictive scores, and markers of severe disease.
12 months
Number of patients with pancreatic necrosis as assessed by their clinical course.
Time Frame: 12 months
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.
Time Frame: 12 months
Evaluation of the current management and outcomes of acute pancreatitis around the world.
12 months
Number of patients with pancreatic necrosis as assessed by their clinical course.
Time Frame: 12 months
Evaluation of the current management and outcomes of acute pancreatitis around the world.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO15040389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Findings will be shared with co-collaborators and the Collaborative Alliance for Pancreatic Education and Research.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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