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

Completed

• Conditions: Pancreatitis
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT03075618
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-23
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Pancreatitis	Questionnaires	Patients with Acute Pancreatitis.

Primary Outcome Measures

Name	Time	Method
Number of patients with persistent organ failure as assessed by their clinical course.	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.	12 months	Evaluation of the current management and outcomes of acute pancreatitis around the world.

Trial Locations

Locations (1)

UPMC Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States