Post Acute Pancreatitis Pancreatic Exocrine Insufficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-21

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

NCT06477159

Exocrine Pancreatic Insufficiency

RECRUITING PHASE4

A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)

NCT00676702

Exocrine Pancreatic Insufficiency Pancreatitis, Chronic Steatorrhea +1 more

COMPLETED PHASE1

PROOF: Pancreatitis-associated Risk Of Organ Failure

NCT03075605

Pancreatitis Organ Failure, Multiple

COMPLETED

A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)

NCT03859869

Exocrine Pancreatic Insufficiency (EPI)

TERMINATED PHASE4

Exocrine Pancreatic Insufficiency After Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy

NCT05480241

Acute Pancreatitis Exocrine Pancreatic Insufficiency Gut Microbiota +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No intervention, this is an observational study

Intervention Type DIAGNOSTIC_TEST

Assessment for exocrine pancreatic insufficiency

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention, this is an observational study

Assessment for exocrine pancreatic insufficiency

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No