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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Pancreatitis | Patients with Acute Pancreatitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Behavioral | Questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with persistent organ failure as assessed by their clinical course. | 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. | 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 |
| Number of patients with pancreatic necrosis as assessed by their clinical course. | Evaluation of the current management and outcomes of acute pancreatitis around the world. | 12 months |
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Inclusion Criteria:
The diagnosis of AP based upon presence of two out of the three following criteria:
Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).
Exclusion Criteria:
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Patients with Acute Pancreatitis, ages 18 and over.
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| Name | Affiliation | Role |
|---|---|---|
| George Papachristou, MD | Ohio State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37428139 | Derived | Lee PJ, Culp S, Kamal A, Paragomi P, Pothoulakis I, Talukdar R, Kochhar R, Goenka MK, Gulla A, Gonzales J, Stevens T, Barbu S, Nawaz H, Gutierrez S, Zarnescu N, Capurso G, Easler J, Triantafyllou K, Ocampo C, de-Madaria E, Wu B, Hart PA, Akshintala VS, Singh VK, Bischof J, Buxbaum J, Pelaez M, Papachristou GI. Lactated Ringers Use in the First 24 Hours of Hospitalization Is Associated With Improved Outcomes in 999 Patients With Acute Pancreatitis. Am J Gastroenterol. 2023 Dec 1;118(12):2258-2266. doi: 10.14309/ajg.0000000000002391. Epub 2023 Jul 10. | |
| 33604947 |
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Findings will be shared with co-collaborators and the Collaborative Alliance for Pancreatic Education and Research.
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Samples will be obtained to study DNA.
| Derived |
| Paragomi P, Tuft M, Pothoulakis I, Singh VK, Stevens T, Nawaz H, Easler JJ, Thakkar S, Cote GA, Lee PJ, Akshintala V, Kamal A, Gougol A, Phillips AE, Machicado JD, Whitcomb DC, Greer PJ, Buxbaum JL, Hart P, Conwell D, Tang G, Wu BU, Papachristou GI. Dynamic changes in the pancreatitis activity scoring system during hospital course in a multicenter, prospective cohort. J Gastroenterol Hepatol. 2021 Sep;36(9):2416-2423. doi: 10.1111/jgh.15430. Epub 2021 Feb 18. |
| 31712075 | Derived | Matta B, Gougol A, Gao X, Reddy N, Talukdar R, Kochhar R, Goenka MK, Gulla A, Gonzalez JA, Singh VK, Ferreira M, Stevens T, Barbu ST, Nawaz H, Gutierrez SC, Zarnescu NO, Capurso G, Easler J, Triantafyllou K, Pelaez-Luna M, Thakkar S, Ocampo C, de-Madaria E, Cote GA, Wu BU, Paragomi P, Pothoulakis I, Tang G, Papachristou GI. Worldwide Variations in Demographics, Management, and Outcomes of Acute Pancreatitis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1567-1575.e2. doi: 10.1016/j.cgh.2019.11.017. Epub 2019 Nov 9. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |