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

Pancreatitis Clinical Trial

— APPRENTICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075618
• Other study ID #: PRO15040389
• Status: Completed
• Start date: July 2015
• Est. completion date: March 23, 2020

Study information

• Verified date: April 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Behavioral:
• Questionnaires
Questionnaires

Locations

Country	Name	City	State
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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