PancreatitisAPPRENTICENCT03075618
Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)
An observational study of Pancreatitis, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 623 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 23 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Acute Pancreatitis, ages 18 and over.
Who may be able to join
- The diagnosis of AP based upon presence of two out of the three following criteria:
- Abdominal pain typical to AP
- Serum amylase or lipase levels more than three times the upper limit of normal
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pancreatitis
- Being tested
- Questionnaires
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Acute Pancreatitis | Patients with Acute Pancreatitis. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startJul 2015
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Whitcomb, University of Pittsburgh
- Investigators
- George Papachristou, MD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075618
- Sponsor's protocol ID
- PRO15040389
- Acronym
- APPRENTICE
- Status last verified
- Apr 2020
- First submitted
- 2 Feb 2017
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Findings will be shared with co-collaborators and the Collaborative Alliance for Pancreatic Education and Research.
Publications
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.
PubMed 37428139Paragomi 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.
PubMed 33604947Matta 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.
PubMed 31712075
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)
- ClinicalTrials.gov ID
- NCT03075618
- Acronym / sponsor ID
- APPRENTICE / PRO15040389
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Pancreatitis | – | Behavioral: QuestionnairesPatients with Acute Pancreatitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Acute Pancreatitis, ages 18 and over.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuestionnaires | Behavioural | Acute Pancreatitis |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 37428139Lee 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.
- Derived from this study: PubMed 33604947Paragomi 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.
- Derived from this study: PubMed 31712075Matta 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.
- Individual participant dataSharing planned: Undecided. Findings will be shared with co-collaborators and the Collaborative Alliance for Pancreatic Education and Research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Papachristou, MD study chair
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with persistent organ failure as assessed by their clinical course. (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.