Clinical trial NCT03075631: Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
Official title: Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 1183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Acute Pancreatitis

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).

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.

Primary outcomes:
measure: Number of patients with pancreatic necrosis as assessed by their clinical course.
timeFrame: 12 months
measure: Number of patients with persistent organ failure as assessed by their clinical course.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Georgios I Papachristou, MD
role: PRINCIPAL_INVESTIGATOR
References: