Clinical trial NCT03063398: Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
Official title: PAPPEI: Post Acute Pancreatitis Pancreatic Exocrine Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-02-24
Enrollment: 196
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: 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)

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exocrine pancreatic insufficiency at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: Ohio State University
name: Georgios I Papachristou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.