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Trial record 21 of 503 for:    pancreatitis

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

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ClinicalTrials.gov Identifier: NCT03075618
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Georgios Papachristou, University of Pittsburgh

Brief 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.

Condition or disease Intervention/treatment
Pancreatitis Behavioral: Questionnaires

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 : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)
Study Start Date : July 2015
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Acute Pancreatitis
Patients with Acute Pancreatitis.
Behavioral: Questionnaires
Questionnaires



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Biospecimen Retention:   Samples With DNA
Samples will be obtained to study DNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Acute Pancreatitis, ages 18 and over.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075618


Contacts
Contact: Emily C Baehr, BA 4126485652 ecb42@pitt.edu

Locations
United States, Pennsylvania
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Emily C Baehr, BA    412-648-5652    ecb42@pitt.edu   
Principal Investigator: Georgios I Papachristou, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Georgios I Papachristou, MD University of Pittsburgh

Responsible Party: Georgios Papachristou, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03075618     History of Changes
Other Study ID Numbers: PRO15040389
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Findings will be shared with co-collaborators and the Collaborative Alliance for Pancreatic Education and Research.

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases