NCT03075631

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,183

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4.3 years

First QC Date

February 2, 2017

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Patients with Acute Pancreatitis

Patients with Acute Pancreatitis

Other: Questionnaire

Interventions

Questionnaires

Patients with Acute Pancreatitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Acute Pancreatitis

You may qualify if:

  • The diagnosis of AP based upon presence of two out of the three following criteria:
  • Abdominal pain typical to AP
  • Serum amylase or lipase levels more than three times the upper limit of normal
  • Imaging findings suggestive of AP
  • Willingness to participate in the study and ability to sign informed consent by patient or his/her proxy (if unable to speak).

You may not qualify if:

  • Age under 18 years
  • Unwilling to provide consent by patient or his/her proxy
  • Presence of pancreatic cancer
  • Presence of chronic pancreatitis
  • Occurrence of AP following a multiple trauma episode
  • Having history of organ transplant
  • Presence of any cancer which required chemotherapy or radiation therapy in the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimens will be collected to look at biological measures.

MeSH Terms

Conditions

Pancreatitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Georgios I Papachristou, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 2, 2017

First Posted

March 9, 2017

Study Start

December 1, 2015

Primary Completion

March 4, 2020

Study Completion

March 4, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations