Post Acute Pancreatitis Pancreatic Exocrine Insufficiency

NCT03063398 | Completed DMC

• 1 other identifier: STUDY19080096
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Exocrine pancreatic insufficiency at 12 months

  Fecal elastase-1 levels EPI below 200 mcg/g stool,

  12 months

Study Arms (1)

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

Interventions

No intervention, this is an observational study DIAGNOSTIC_TEST

Assessment for exocrine pancreatic insufficiency

Patients after 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

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)

You may qualify if:

• 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)

You may not qualify if:

• Known or newly diagnosed chronic pancreatitis based on cross sectional imaging findings
• 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

Sponsors & Collaborators

• Ohio State University: lead
• AbbVie: collaborator

Study Sites (3)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21225, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Bejjani J, Culp S, Nikahd M, Phillips AE, Singh V, Roberts KM, Abu-El-Haija M, Krishna SG, Ramsey ML, Lahooti A, Lee PJ, Hart PA, Papachristou GI. Symptom Burden After Acute Pancreatitis and Its Correlation With Exocrine Pancreatic Function: A Multicenter Prospective Study. Clin Transl Gastroenterol. 2025 Feb 1;16(2):e00799. doi: 10.14309/ctg.0000000000000799.

  PMID: 39679584 DERIVED

• Phillips AE, Bejjani J, Culp S, Chennat J, Lee PJ, Machicado JD, Singh VK, Afghani E, Ramsey ML, Paragomi P, Stello K, Nikahd M, Hart PA, Papachristou GI. Prevalence of exocrine pancreatic insufficiency at 12 months after acute pancreatitis: a prospective, multicentre, longitudinal cohort study. EClinicalMedicine. 2024 Aug 2;75:102774. doi: 10.1016/j.eclinm.2024.102774. eCollection 2024 Sep.

  PMID: 39210941 DERIVED

• Bejjani J, Papachristou GI, Dungan K, Evans Phillips A, Singh V, Toledo FG, Han S, Krishna SG, Lahooti A, Lee PJ, Machicado JD, Nikahd M, Paragomi P, Ramsey M, Yadav D, Culp S, Hart PA. Incident diabetes following acute pancreatitis in a multicenter prospective observational cohort. Pancreatology. 2023 Dec;23(8):900-903. doi: 10.1016/j.pan.2023.10.009. Epub 2023 Oct 10.

  PMID: 37839923 DERIVED

• 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.

  PMID: 33565790 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and fecal samples will be collected for future Pancreatitis studies concerning EPI or genetics.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Georgios I Papachristou, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 24, 2017
• Study Start: June 21, 2017
• Primary Completion: February 1, 2023
• Study Completion: June 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (3)