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

NCT03075618 | Completed DMC

• 1 other identifier: PRO15040389
• Study Type: observational
• Target: 623
• Locations: 1 country
• Sites: 1

Brief Summary

The management of acute pancreatitis is mainly based on expert opinions; large randomized controlled trials are missing and novel therapeutic approaches are considered necessary. This study will evaluate the current management and outcomes of acute pancreatitis around the world.

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (4)

• Number of patients with persistent organ failure as assessed by their clinical course.

  Evaluation of the existing risks, predictive scores, and markers of severe disease.

  12 months

• 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

• Number of patients with pancreatic necrosis as assessed by their clinical course.

  Evaluation of the current management and outcomes of acute pancreatitis around the world.

  12 months

Study Arms (1)

Acute Pancreatitis

Patients with Acute Pancreatitis.

Behavioral: Questionnaires

Interventions

Questionnaires BEHAVIORAL

Questionnaires

Acute Pancreatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Acute Pancreatitis, ages 18 and over.

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Lee PJ, Culp S, Kamal A, Paragomi P, Pothoulakis I, Talukdar R, Kochhar R, Goenka MK, Gulla A, Gonzales J, Stevens T, Barbu S, Nawaz H, Gutierrez S, Zarnescu N, Capurso G, Easler J, Triantafyllou K, Ocampo C, de-Madaria E, Wu B, Hart PA, Akshintala VS, Singh VK, Bischof J, Buxbaum J, Pelaez M, Papachristou GI. Lactated Ringers Use in the First 24 Hours of Hospitalization Is Associated With Improved Outcomes in 999 Patients With Acute Pancreatitis. Am J Gastroenterol. 2023 Dec 1;118(12):2258-2266. doi: 10.14309/ajg.0000000000002391. Epub 2023 Jul 10.

  PMID: 37428139 DERIVED

• Paragomi P, Tuft M, Pothoulakis I, Singh VK, Stevens T, Nawaz H, Easler JJ, Thakkar S, Cote GA, Lee PJ, Akshintala V, Kamal A, Gougol A, Phillips AE, Machicado JD, Whitcomb DC, Greer PJ, Buxbaum JL, Hart P, Conwell D, Tang G, Wu BU, Papachristou GI. Dynamic changes in the pancreatitis activity scoring system during hospital course in a multicenter, prospective cohort. J Gastroenterol Hepatol. 2021 Sep;36(9):2416-2423. doi: 10.1111/jgh.15430. Epub 2021 Feb 18.

  PMID: 33604947 DERIVED

• Matta B, Gougol A, Gao X, Reddy N, Talukdar R, Kochhar R, Goenka MK, Gulla A, Gonzalez JA, Singh VK, Ferreira M, Stevens T, Barbu ST, Nawaz H, Gutierrez SC, Zarnescu NO, Capurso G, Easler J, Triantafyllou K, Pelaez-Luna M, Thakkar S, Ocampo C, de-Madaria E, Cote GA, Wu BU, Paragomi P, Pothoulakis I, Tang G, Papachristou GI. Worldwide Variations in Demographics, Management, and Outcomes of Acute Pancreatitis. Clin Gastroenterol Hepatol. 2020 Jun;18(7):1567-1575.e2. doi: 10.1016/j.cgh.2019.11.017. Epub 2019 Nov 9.

  PMID: 31712075 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be obtained to study DNA.

MeSH Terms

Conditions

Pancreatitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• George Papachristou, MD

  Ohio State University

  STUDY CHAIR

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: July 1, 2015
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

US (1)