Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2 (APPRENTICE2)

This study is an ancillary of APPRENTICE. This will be the international based study.

Study Overview

• Status: Completed
• Conditions: Pancreatitis
• Intervention / Treatment: Other: Questionnaire

Detailed Description

This study is an ancillary of APPRENTICE. This will be the international based study. The initial study design with discussions about the different variables to be included into our 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. We 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.University of Pittsburgh will be responsible for collecting all required regulatory documents from other sites. Developing templates for questionnaires and other data collection forms. Will train approved sites on procedures. The coordinating center will be the recipient of de-identified data and will not be involved in the collection of data.

Note that copies of training records, licenses, certificates should be maintained in the study regulatory binder and are subject to audit by the Research Conduct and Compliance Office (RCCO).

• Study Type: Observational
• Enrollment (Actual): 1183

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Acute Pancreatitis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Acute Pancreatitis	Other: Questionnaire; Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Georgios I Papachristou, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: PRO15100089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The results will be shared with the other IRB approved sites associated with this study.