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

Pancreatitis Clinical Trial

— APPRENTICE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075631
• Other study ID #: PRO15100089
• Status: Completed
• Start date: December 2015
• Est. completion date: March 4, 2020

Study information

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

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1183
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 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

Other:
• Questionnaire
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 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