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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 2015
End Date:July 2025
Contact:Pedram Paragomi, MD
Email:paragomi@pitt.edu
Phone:4126485652

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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.

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.

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.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Georgios I Papachristou, MD
Phone: 412-648-5652
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Pittsburgh, PA
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