Post Acute Pancreatitis Pancreatic Exocrine Insufficiency (PAPPEI)

PAPPEI: Post Acute Pancreatitis Pancreatic Exocrine Insufficiency

This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Diagnostic test: No intervention, this is an observational study

Detailed Description

This study is a proposed a comprehensive prospective assessment of exocrine pancreatic insufficiency (EPI), nutritional status, and quality of life (QOL) during the early re-feeding phase, at 3 months, and 12 months following an AP attack. A blood sample will be collected for measurement of nutritional markers and a fecal sample for elastase-1, and data regarding demographics, etiology, history of previous pancreatitis episodes, and their hospital course (imaging findings, interventions, length of stay, intensive care admission, and severity based on the Revised Atlanta Classification) will be obtained from medical records at hospital discharge. Subsequently, each subject will be prospectively followed at 3 months and 1 year after hospital discharge. In each follow-up, he/she will be asked to answer a questionnaire focusing on symptoms of exocrine pancreatic insufficiency and quality of life. Furthermore, blood and stool samples will be collected at the 3 and 12-month follow up for measurement of nutritional markers and fecal elastase-1 levels.

Based on available literature and our own data, we hypothesize that a significant fraction of AP patients develop EPI that may persist up to 1 year after the discharge, and result in nutritional deficiencies and impaired QOL. This study will help to clarify the incidence, natural history and duration of EPI, as well as identify subgroups of patients at high risk of EPI after AP. It will serve as the basis for the design of future randomized controlled trials of pancreatic enzyme replacement following AP. This is a novel proposal by an investigator with extensive experience and a well-established record in AP research from an internationally known pancreas center of excellence. The methodological strength of our proposal lies on its prospective nature, the 1-year follow up with serial assessments of EPI, nutritional status and QOL, and the detailed phenotypical characterization of the AP patient cohort.

Primary endpoints

• Measure the incidence of exocrine pancreatic insufficiency at 12 months after an attack of AP.

Secondary endpoints

• Identify subgroups of patients at risk for EPI at 12 months after an attack of AP based on severity classification, etiology, and demographics.
• Measure the incidence of transient (present at 3 but no at 12 months) and persistent (present both at 3 and 12 months after AP) exocrine pancreatic insufficiency following an AP attack.
• Measure the incidence of nutritional deficiencies, and impaired quality of life at 3 and 12 months from an attack of AP.
• Assess whether EPI is associated with nutritional deficiencies or impaired quality of life at 3 and 12 months from an AP attack.

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Johns Hopkins Medical Institutions
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria:

• Abdominal pain consistent with the disease,
• Serum amylase and/or lipase greater than three times the upper limit of normal, and or
• Characteristic findings from abdominal imaging (i.e. demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis)

Description

Inclusion Criteria:

• Men and women, at least 18 years of age, admitted at the University of Pittsburgh Medical Center with an AP attack defined as the presence of 2 or more of the following criteria:

  • Abdominal pain consistent with the disease,
  • Serum amylase and/or lipase greater than three times the upper limit of normal, and or
  • Characteristic findings from abdominal imaging (i.e. demonstrating pancreatic edema, peripancreatic fat stranding or complications or acute pancreatitis)

Exclusion Criteria:

• Known or newly diagnosed chronic pancreatitis based on cross sectional imaging findings
• Pre-existing exocrine pancreatic insufficiency (meaning EPI present before the onset of AP; development of EPI during early refeeding is not an exclusion criterion)
• History of gastric or pancreatic resection
• History of small bowel disease (celiac disease, or Crohn's disease)
• History of pancreatic malignancy
• History of gastroparesis
• History of cystic fibrosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients after acute pancreatitis; Such patients will be followed and assessed for the development of Exocrine Pancreatic Insufficiency. 'No intervention, this is an observational study.	Diagnostic test: No intervention, this is an observational study; Assessment for exocrine pancreatic insufficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exocrine pancreatic insufficiency at 12 months	Fecal elastase-1 levels EPI below 200 mcg/g stool,	12 months

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: AbbVie
• Investigators: Principal Investigator: Georgios I Papachristou, MD, Ohio State University

Publications and helpful links

General Publications

• Paragomi P, Phillips AE, Machicado JD, Lahooti A, Kamal A, Afghani E, Pothoulakis I, Reynolds SL, Mays M, Conwell DL, Lara LF, Singh VK, Papachristou GI. Post-Acute Pancreatitis Pancreatic Exocrine Insufficiency: Rationale and Methodology of a Prospective, Observational, Multicenter Cohort Study. Pancreas. 2021 Feb 1;50(2):147-152. doi: 10.1097/MPA.0000000000001743.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): February 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: STUDY19080096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: In the future, the data may be shared with other entities. If so, the research data/documents will be coded and subject identifiers removed prior to access by the external persons.