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

NCT ID: NCT03075631

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-03-04

Brief Summary

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

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).

Conditions

Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Acute Pancreatitis

Patients with Acute Pancreatitis

Questionnaire

Intervention Type: OTHER

Questionnaires

Interventions

Questionnaire

Questionnaires

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Georgios Papachristou

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios I Papachristou, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO15100089

Identifier Type: -

Identifier Source: org_study_id